Back Clinic Chiropractic. This is a form of alternative treatment that focuses on the diagnosis and treatment of various musculoskeletal injuries and conditions, especially those associated with the spine. Dr. Alex Jimenez discusses how spinal adjustments and manual manipulations regularly can greatly help both improve and eliminate many symptoms that could be causing discomfort to the individual. Chiropractors believe among the main reasons for pain and disease are the vertebrae’s misalignment in the spinal column (this is known as a chiropractic subluxation).
Through the usage of manual detection (or palpation), carefully applied pressure, massage, and manual manipulation of the vertebrae and joints (called adjustments), chiropractors can alleviate pressure and irritation on the nerves, restore joint mobility, and help return the body’s homeostasis. From subluxations, or spinal misalignments, to sciatica, a set of symptoms along the sciatic nerve caused by nerve impingement, chiropractic care can gradually restore the individual’s natural state of being. Dr. Jimenez compiles a group of concepts on chiropractic to best educate individuals on the variety of injuries and conditions affecting the human body.
Back pain is one of the most common causes people visit their healthcare professional every year. A primary care physician is often the first doctor who can provide treatment for a variety of injuries and/or conditions, however, among those individuals seeking complementary and alternative treatment options for back pain, most people choose chiropractic care. Chiropractic care focuses on the diagnosis, treatment and prevention of trauma and disease of the musculoskeletal and nervous systems, by correcting misalignments of the spine through the use of spinal adjustments and manual manipulations.
Approximately 35% of individuals seek chiropractic treatment for back pain caused by automobile accidents, sports injuries, and a variety of muscle strains. When people suffer an trauma or injury as a result of an accident, however, they may first receive treatment for their symptoms of back pain in a hospital. Hospital outpatient care describes treatment which does not require an overnight stay at a medical facility. A research study conducted an analysis comparing the effects of chiropractic care and hospital outpatient management for back pain. The results are described in detail below.
Abstract
Objective: To compare the effectiveness over three years of chiropractic and hospital outpatient management for low back pain.
Design: Randomised allocation of patients to chiropractic or hospital outpatient management.
Setting: Chiropractic clinics and hospital outpatient departments within reasonable travelling distance of each other in I I centres.
Subjects: 741 men and women aged 18-64 years with low back pain in whom manipulation was not contraindicated.
Outcome measures: Change in total 0swestry questionnaire score and in score for pain and patient satisfaction with allocated treatment.
Results: According to total 0swestry scores improvement in all patients at three years was about 291/6 more in those treated by chiropractors than in those treated by the hospitals. The beneficial effect of chiropractic on pain was particularly clear. Those treated by chiropractors had more further treatments for back pain after the completion of trial treatment. Among both those initially referred from chiropractors and from hospitals more rated chiropractic helpful at three years than hospital management.
Conclusions: At three years the results confirm the findings of an earlier report that when chiropractic or hospital therapists treat patients with low back pain as they would in day to day practice those treated by chiropractic derive more benefit and long term satisfaction than those treated by hospitals.
Introduction
In 1990 we reported greater improvement in patients with low back pain treated by chiropractic compared with those receiving hospital outpatient management. The trial was “pragmatic” in allowing the therapists to treat patients as they would in day to day practice. At the time of our first report not all patients had been in the trial for more than six months. This paper presents the full results up to three years for all patients for whom follow up information from Oswestry questionnaires and for other outcomes was available for analysis. We also present data on pain from the questionnaire, which is by definition the main complaint prompting referral or self referral.
Methods
Methods were fully described in our first report. Patients initially referred or presenting either to a chiropractic clinic or in hospital were randomly allocated to be treated either by chiropractic or in hospital. A total of 741 patients started treatment. Progress was measured with the Oswestry questionnaire on back pain, which gives scores for I 0 sections for example, intensity of pain and difficulty with lifting, walking, and travelling. The result is expressed on a scale ranging from 0 (no pain or difficulties) to 100 (highest score for pain and greatest difficulty on all items). For an individual item, such as pain, scores range from 0 to 10. The main outcome measures are the changes in Oswestry score from before treatment to each follow up. At one, two, and three years patients were also asked about further treatment since the completion of their trial treatment or since the previous annual questionnaire. At the three year follow up patients were asked whether they thought their allocated trial treatment had helped their back pain.
In the random allocation of treatment minimisation was used within each centre to establish groups for the analysis of results according to initial referral clinic, length of current episode (more or less than ‘a month), presence or absence of a history of back pain, and an Oswestry score at entry of > 40 or <=40%.
Results were analysed on an intention to treat basis (subject to the availability of data at follow up as well as at entry for individual patients). Differences between mean changes were tested by unpaired t tests, and X2 tests were used to test for differences in proportions between the two treatment groups.
Dr. Alex Jimenez’s Insight
Chiropractic is a natural form of health care which purpose is to restore and maintain the function of the musculoskeletal and nervous systems, promoting spinal health and allowing the body to heal itself naturally. Our philosophy emphasizes on the treatment of the human body as a whole, rather than on the treatment of a single injury and/or condition. As an experienced chiropractor, my goal is to properly assess patients in order to determine which type of treatment will most effectively heal their individual type of health issue. From spinal adjustments and manual manipulations to physical activity, chiropractic care can help correct spinal misalignments that cause back pain.
Results
Follow up Oswestry questionnaires were returned by a consistently higher proportion of patients allocated to chiropractic than to hospital treatment. At six weeks, for example, they were returned by 95% and 89% of chiropractic and hospital patients, respectively and at three years by 77% and 70%.
Mean (SD) scores before treatment were 29-8 (14-2) and 28-5 (14-1) in the chiropractic and hospital treatment groups, respectively. Table I shows the differences between the mean changes in total Oswestry scores according to randomly allocated treatment group. The difference at each follow up is the mean change for the chiropractic group minus the mean change for the hospital group.
Positive differences therefore reflect more improvement (due to a greater change in score) in those treated by chiropractic than in hospital (negative differences the reverse). The 3-18 percentage point difference at three years in table I represents a 29% greater improvement in patients treated with chiropractic compared with hospital treatment, the absolute improvement in the two groups at this time being 14-1 and 10-9 percentage points, respectively. As in the first report those with short current episodes, a history of back pain, and initially high Oswestry scores tended to derive most benefit from chiropractic. Those referred by chiropractors consistently derived more benefit from chiropractic than those referred by hospitals.
Table II shows changes between the scores on pain intensity before treatment and the corresponding scores at the various follow up intervals. All these changes were positive that is, indicated improvement but were all significantly greater in those treated by chiropractic, including the changes early on that is, at six weeks and six months, when the proportions returning questionnaires were high. As with the results based on the full Oswestry score the improvement due to chiropractic was greatest in those initially referred by chiropractors, although there was also a non-significant improvement (ranging from 9% at six months to 34% at three years) due to chiropractic at each follow up interval in those referred by hospitals.
Other scores for individual items on the Oswestry index to show significant improvement attributable to chiropractic were ability to sit for more than a short time and sleeping (P=0’004 and 0 03, respectively, at three years), though the differences were not as consistent as for pain. Other scores (personal care, lifting, walking, standing, sex life, social life, and travelling) also nearly all improved more in the patients treated with chiropractic, though most of the differences were small compared with the differences for pain.
Higher proportions of patients allocated to chiropractic sought further treatment (of any kind) for back pain after completion of trial treatment than those managed in hospital. For example, between one and two years after trial entry 122/292 (42%) patients treated with chiropractic compared with 80/258 (3 1%) of hospital treated patients did so (Xl=6 8, P=0 0 1).
Table III shows the proportions of patients at three years who thought their allocated trial treatment had helped their back pain. Among those initially referred by hospitals as well as among those initially referred by chiropractors higher proportions treated by chiropractic considered that treatment had helped compared with those treated in hospital.
Key Messages
Back pain often remits spontaneously
Effective treatments for non-remitting episodes need to be more clearly identified
Chiropractic seems to be more effective than hospital management, possibly because more treatments are spread over longer time periods
A growing number of NHS purchasers are making complementary treatments, including chiropractic, available
Further trials to identify the effective components of chiropractic are needed
Discussion
The results at six weeks and six months shown in table I are identical with those in our first report, as all patients had then been followed up for six months. The findings at one year are similar as many patients had also been followed up then. The considerably larger numbers of patients with data now available at two and three years show smaller benefits at these intervals than previously, though these still significantly favour chiropractic. The substantial benefit of chiropractic on intensity of pain is evident early on and then persists. The consistently larger proportions lost to follow up throughout the trial in those treated in hospital than in those treated by chiropractic suggests greater satisfaction with chiropractic. This conclusion is supported (table III) by the higher proportions in each referral group considering chiropractic helpful by comparison with hospital treatment.
The main criticism of the trial after our first report centred on its “pragmatic” nature, particularly the larger number of chiropractic than hospital treatments and the longer period over which the chiropractic treatments were spread and which were deliberately allowed. These considerations and any consequences of the higher proportions of patients allocated to chiropractic who received further treatment in the later stages of follow up, however, do not apply to the results at six weeks and only apply to a limited extent at six months, when the proportions followed up were high and extra treatment had either not occurred at all or was not yet extensive. Benefits atributable to chiropractic were already evident (especially on pain, table II) at these shorter intervals.
We believe there is now more support for the need for “fastidious” trials focusing on specific components of management and on their feasibility. Meanwhile, the results of our trial show that chiropractic has a valuable part to play in the management of low back pain.
We thank Dr Iain Chalmers for commenting on an earlier draft of the paper. We thank the nurse coordinators, medical staff, physiotherapists, and chiropractors in the 11 centres for their work, and Dr Alan Breen of the British Chiropractic Association for his help. The centres were in Harrow Taunton, Plymouth, Bournemouth and Poole, Oswestry, Chertsey, Liverpool, Chelmsford, Birmingham, Exeter, and Leeds. Without the assistance of many staff members in each the trial could not have been completed.
Funding: Medical Research Council, the National Back Pain Association, the European Chiropractors Union, and the King Edward’s Hospital Fund for London.
Conflict of interest: None.
In conclusion,�after three years, the results of the research study comparing chiropractic care and hospital outpatient management for low back pain determined that people treated by chiropractic experienced more benefits as well as long-term satisfaction than those treated by hospitals. Because back pain is one of the most common�causes people visit their healthcare professional every year, its essential to seek the most effective type of health care. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
References
Meade TW, Dyer S, Browne W, Townsend J, Frank AO. Low back pain of mechanical origin: randomised comparison of chiropractic and hospital outpatient treatment.�BMJ.�1990 Jun 2;300(6737):1431�1437.�[PMC free article]�[PubMed]
Fairbank JC, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire.�Physiotherapy.�1980 Aug;66(8):271�273.�[PubMed]
Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial.�Biometrics.�1975 Mar;31(1):103�115.�[PubMed]
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
In association with professional experience in fitness and chiropractic care,�symptoms of back pain have been determined to improve in people who participate in physical activity and exercise, as directed by a physiotherapist, or physical therapist, or any other healthcare professional, such as a chiropractor. Various complementary and alternative treatment options for back pain also involve the use of functional fitness therapy, however, additional evidence-based research studies on the effectiveness of physical activity and exercise are still needed.
On a personal note, chiropractic care utilizes spinal adjustments and manual manipulations to carefully correct misalignments on the spine, or spinal subluxations. Along with chiropractic treatment, a doctor of chiropractor may also recommend a series of stretches and exercises to help increase flexibility, strength and mobility, improving the overall function of the spine. Physical activity for low back pain has been evaluated in the randomized controlled trial below.
Abstract
Objective
To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities.
Design
Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients� preferences for type of management were elicited independently of randomisation.
Participants
187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months� duration.
Interventions
Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used.
Main Outcome Measures
Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services.
Results
At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients� preferences.
Conclusions
The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective.
Key Messages
Patients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmful
An exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year later
Patients� preferences for type of management did not affect outcome
Patients in the intervention group tended to use fewer healthcare resources and took fewer days off work
This type of exercise programme should be more widely available
Introduction
Low back pain is common and, although it may settle quickly, recurrence rates are about 50% in the following 12 months. Recent management guidelines recommend that an early return to physical activities should be encouraged, but patients are often afraid of movement after an acute onset of back pain. Trials of specific exercise programmes for acute back pain have not shown them to be effective, but a specific exercise programme may have to be tailored to suit the individual patient and so is less likely to be effective for a heterogeneous group of patients.
However, there is some evidence that a general exercise programme, which aims to increase individuals� confidence in the use of their spine and overcome the fear of physical activity, can be effective for patients with chronic back pain (of more than six months� duration). A recent randomised trial of a supervised exercise programme in a hospital setting reported significantly better outcomes at six months and two years for the exercise group compared with the control group. Whether this approach would be effective and cost effective for patients with low back pain of less than six months� duration in a primary care setting is unknown.
An important methodological problem occurs when it is not possible to blind subjects to the treatment they receive, since outcome is probably directly influenced by their preconceived ideas regarding the effectiveness of intervention. Thus, in trials where a double blind procedure is not feasible, participants who are not randomised to their treatment of choice may be disappointed and suffer from resentful demoralisation, whereas those randomised to their preferred treatment may have a better outcome irrespective of the physiological efficacy of the intervention. However, this problem may be partly ameliorated if patients� treatment preferences are elicited before randomisation, so that they can be used to inform the analysis of costs and outcomes.
In this paper, we report a fully randomised trial for the treatment of subacute low back pain in which the analysis was informed by patient preference.
Subjects and Methods
Recruitment of Subjects
Eighty seven general practitioners agreed to participate in the study, and the principal investigator (JKM) visited each practice to discuss participation. Selection of general practitioners was based in the York area and restricted by the need to provide easy access for patients to the classes. Only one invited practice declined to participate. Single handed practices were not invited. The general practitioners referred patients directly to the research team or sent a monthly list of patients who had consulted with back pain. Inclusion criteria were patients with mechanical low back pain of at least four weeks� duration but less than six months, aged between 18 and 60, declared medically fit by their general practitioner to undertake the exercise, and who had consulted one of the general practitioners participating in the study. Patients with any potentially serious pathology were excluded, as were any who would have been unable to attend or participate in the classes. The exclusion criteria were the same as described by Frost et al except that concurrent physiotherapy rather than previous physiotherapy was an exclusion criterion in this trial.
Evaluation
Patients who seemed eligible were contacted by telephone and if they were interested in participating in the study were invited to an initial interview, at which the study and its implications for participants were explained. Patients who met all the eligibility criteria and consented to participate attended a first assessment a week later.
This included a physical examination (to exclude possible serious spinal pathology) and collection of baseline data by means of validated measures of health status. The main outcome measures were the Roland back pain disability questionnaire, which measures functional limitations due to back pain, and the Aberdeen back pain scale, which is more a measure of clinical status. The Roland disability questionnaire consists of a 24 point scale: a patient scoring three points on the scale means that he or she reports, for example, �Because of my back I am not doing any of the jobs that I usually do around the house, I use a handrail to get upstairs, and I lie down to rest more often.� We also administered the EuroQoL health index (EQ-5D) and the fear and avoidance beliefs questionnaire (FABQ).
The second assessment was carried out at the patients� general practice six weeks after randomisation to treatment. The brief physical examination was repeated, and the patients were asked to complete the same outcome questionnaires.
In addition, patients were asked to complete pain diaries in the week before their first assessment and in the week before their second assessment. The diaries were used to assess subjective pain reports and asked �How strong is the pain?� and �How distressing is the pain?�
We also evaluated patients at six and 12 months� follow up by sending them outcome questionnaires to complete and return.
Randomisation and Treatments
A pre-prepared randomisation list was generated from a random numbers table and participants were stratified by practice in blocks of six. The trial coordinator ensured concealment of allocation from the clinical researchers by providing the research physiotherapist with a sealed envelope for a named patient before baseline assessment. A note inside the envelope invited the participant either to attend exercise classes or to continue with the current advice or treatment offered by his or her general practitioner. (One of the referring general practitioners used manipulation as usual treatment on most of his patients so that up to 37 patients in each arm of the study could also have received manipulation.) Each patient had an equal chance of being allocated to the intervention or the control group. Before patients were given their envelope they were asked whether they had any preference for the treatment assignment. The participants opened the envelope after leaving the surgery.
Intervention group�The exercise programme consisted of eight sessions, each lasting an hour, spread out over four weeks, with up to 10 participants in each class. The programme was similar to the Oxford fitness programme and included stretching exercises, low impact aerobic exercises, and strengthening exercises aimed at all the main muscle groups. The overall aim was to encourage normal movement of the spine. No special equipment was needed. Participants were discouraged from viewing themselves as invalids and from following the precept of �Let pain be your guide.� They were encouraged to improve their individual record and were selectively rewarded with attention and praise. Although partly based on a traditional physiotherapy approach, the programme used cognitive-behavioural principles. One simple educational message encouraging self reliance was delivered at each class. Participants were told that they should regard the classes as a stepping stone to increasing their own levels of activity.
Controls�Patients allocated to the control group continued under the care of their doctor and in some cases were referred to physiotherapy as usual. No attempt was made to regulate the treatment they received, but it was recorded.
Economic Analysis
We recorded patients� use of healthcare services using a combination of retrospective questionnaires and prospective diary cards, which they returned at 6 and 12 months� follow up. From this information we estimated the cost of each patient�s treatment. We compared the mean costs of treatment for the two groups by using Student�s t tests and standard confidence intervals. However, as cost data were highly positively skewed, these results were checked with a non-parametric �bootstrap.� The economic evaluation addressed both costs to the NHS and the costs to society. Participants were not charged for the classes, in line with any treatment currently available on the NHS.
Statistical Analysis
Our original intention was to recruit 300 patients, which, given a standard deviation of 4, would have provided 90% power at the 5% significance level to detect a 1.5 point difference between the two groups in the mean change on the Roland disability questionnaire. However, recruitment of patients to the study proved much slower than expected, and, because of the limitations of study resources, recruiting was stopped after 187 patients had been included into the study. This smaller sample reduced the power to detect such a difference to 72%, but there was still 90% power to detect a 2 point difference in outcome.
Our analysis was based on intention to treat. We estimated the effects of treatment on the outcome measures by means of analysis of covariance, with the change in scores as the dependent variable and adjustment being made for baseline score and patient preference. We used Student�s t tests to analyse the data from the pain diaries as the baseline scores were quite similar.
Dr. Alex Jimenez’s Insight
In consideration with the research study regarding a randomized controlled trial coordinated to determine the effectiveness of functional fitness towards the improvement of low back pain, we supplement our philosophies of overall health and wellness to our patients and we make sure to take their recovery and rehabilitation to the next level. Our fitness and chiropractic care treatment goes beyond many other medically advanced methods. The proprietary treatment methods offered at our clinic promote true well-being and fitness practices with a primary goal on the calibration of the human body. The outcome measures of the randomized controlled trial on exercise for low back pain involved two groups of participants, an intervention group and a control group. The results are recorded below.
Results
Study Population
Of the 187 patients included in the trial, 89 were randomised to the intervention and 98 to the control group. The figure shows their progress through the trial. In both groups those with the most severe back pain at randomisation were less likely to return follow up questionnaires: the mean Roland disability questionnaire score for responders at one year follow up was 5.80 (SD 3.48) compared with a mean score of 9.06 (4.58) for non responders respectively (P=0.002).
Baseline Characteristics
The clinical and demographic characteristics of the patients in the two groups were fairly well balanced at randomisation (Table 1), although those allocated to the intervention group tended to report more disability on the Roland disability questionnaire than did the control group. Most patients (118, 63%), when asked, would have preferred to be allocated to the exercise programme. Attendance of the classes was considered quite good, with 73% of the intervention group attending between six and eight of the classes. Four people failed to attend any classes and were included in the intention to treat analysis. No patients allocated to the control group took part in the exercise programme.
Table 1: Baseline characteristics of patients with mechanical low back pain included in study. Values are means (standard deviations) unless stated otherwise.
Clinical Outcomes
Table ?2 shows the mean changes in outcome measures over time, from randomisation to final follow up at one year. After adjustment for baseline scores, the intervention group showed greater decreases in all measures of back pain and disability compared with the controls. At six weeks after randomisation, patients in the intervention group reported less distressing pain than the control group (P=0.03) and a marginally significant difference on the Roland disability questionnaire scores. Other variables were not significantly different, but the differences in change were all in favour of the intervention group. At six months the difference of the mean change scores of the Roland disability questionnaire was significant, and at one year the differences in changes of both the Roland disability questionnaire and the Aberdeen back pain scale were significant (Table ?2). Most of the intervention group improved by at least three points on the Roland disability questionnaire: 53% (95% confidence interval 42% to 64%) had done so at six weeks, 60% (49% to 71%) at six months, and 64% (54% to 74%) at one year. A smaller proportion of the control group achieved this clinically important improvement: 31% (22% to 40%) at six weeks, 40% (29% to 50%) at six months, and 35% (25% to 45%) at one year.
Table 2: Changes in back pain scores from baseline values in intervention and control groups at 6 weeks, 6 months, and 1 year follow up.
Patients� Preference
We examined the effect of patients� baseline preference for treatment on outcome after adjusting for baseline scores and main effects. Preference did not significantly affect response to treatment. The intervention had similar effects on both costs and outcomes regardless of baseline preference. For example, the change in the Roland disability questionnaire score at 12 months in the control group was ?1.93 for patients who preferred intervention and ?1.18 for those who were indifferent (95% confidence interval of difference ?1.05 to 2.55), and in the intervention group the change in score was ?3.10 for those who preferred intervention and ?3.15 for those who were indifferent ((95% confidence interval of difference ?1.47 to 3.08). As the interaction term (preference by random allocation) was non-significant, the results shown in Table ?2 exclude the preference term.
Economic Evaluation
Patients in the intervention group tended to use fewer healthcare and other resources compared with those in the control group (Table ?3). However, the mean difference, totalling �148 per patient, was not significant: the 95% confidence interval suggests there could have been a saving of as much as �442 per patient in the intervention group or an additional cost of up to �146. Patients in the control group took a total of 607 days off work during the 12 months after randomisation compared with 378 days taken off by the intervention group.
Table 3: Use of services and their costs associated with back pain in the two study groups at 12 months follow up.
Discussion
Our results support the hypothesis that a simple exercise class can lead to long term improvements for back pain sufferers. Studies have shown that a similar programme for patients with chronic back pain can be effective in the hospital setting. In this study we show the clinical effectiveness for patients with subacute or recurrent low back pain who were referred by their general practitioner to a community programme.
Current management guidelines for low back pain recommend a return to physical activity and taking exercise. In particular, they recommend that patients who are not improving at six weeks after onset of back pain, which may be a higher proportion than previously realised, should be referred to a reactivation programme. The programme we evaluated fits that requirement well. It shows participants how they can safely start moving again and increase their levels of physical activity. It is simple and less costly than individual treatment.
It seemed to have beneficial effects even one year later, as measured by functional disability (Roland disability questionnaire) and clinical status (Aberdeen back pain scale). The mean changes in scores on these instruments were small, with many patients reporting mild symptoms on the day of entry to the trial. However, a substantially larger proportion of participants in the exercise classes gained increases of over three points on the Roland disability questionnaire at six weeks, six months, and one year, which might be clinically important. At six weeks, participants in the exercise classes reported significantly less distressing pain compared with the control group, although the intensity of pain was not significantly different. This is consistent with findings from a study of chronic back pain patients in Oxford, in which changes in distressing pain were much greater than were the changes in intensity of pain.
People with back pain who use coping strategies that do not avoid movement and pain have less disability. In our study the participants in the exercise classes were able to function better according to Roland disability questionnaire scores than the control group at six months and one year after randomisation to treatment, and at one year they also showed a significantly greater improvement in clinical status as measured by the Aberdeen back pain scale. This increase in differences in effect between the intervention and control groups over time is consistent with the results from long term follow up in comparable back pain trials.
Study Design
The design of this study was a conventional randomised controlled trial in that all eligible patients were randomised. However, the participants were asked to state their preferred treatment before they knew of their allocation. A study of antenatal services showed that preferences can be an important determinant of outcome, but we did not find any strong effect of preference on the outcome, although a much larger sample size would be needed to confidently exclude any modest interaction between preference and outcome. This information may be useful to clinicians in that it suggests that exercise classes are effective even in patients who are not highly motivated. Our trial design, of asking patients for their preferences at the outset, has substantial advantages over the usual patient preference design, in which costs and outcomes cannot be reliably controlled for confounding by preference.
Conclusions
Our exercise programme did not seem to influence the intensity of pain but did affect the participants� ability to cope with the pain in the short term and even more so in the longer term. It used a cognitive-behavioural model, shifting the emphasis away from a disease model to a model of normal human behaviour, and with minimal extra training a physiotherapist can run it. Patients� preferences did not seem to influence the outcome.
Figure 1: Flow chart describing patients’ progress through the trial.
Footnotes
Funding: This research was funded by the Arthritis Research Campaign, the Northern and Yorkshire Regional Health Authority, and the National Back Pain Association.
Competing interests: None declared.
In conclusion,�the participation of patients in functional fitness and/or exercise as recommended by a physiotherapist, or physical therapist, or any other healthcare professional, such as a chiropractor, is essential towards the improvement of their symptoms of low back pain. The exercise programme helped patients better cope with their symptoms of back pain where the intervention group showed that they used fewer healthcare resources and took fewer day off work, according to the outcome measures of the research study. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
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Attributed from a personal perspective, as a practicing chiropractor with experience on a variety of spinal injuries and conditions, back pain is one of the most common health issues reported among the general population, affecting about 8 out of 10 individuals at some point throughout their lives. While many different types of treatments are currently available to help improve the symptoms of back pain, health care based on clinical and experimental evidence has caused an impact on the type of treatment individuals will receive for their back pain. Many patients in health care are turning to non-invasive treatment modalities for their back pain as a result of growing evidence associated with its safety and effectiveness.
On a further note, non-invasive treatment modalities are defined as conservative procedures which do not require incision into the body, where no break in the skin is created and there is no contact with the mucosa or internal body cavity beyond a natural or artificial body orifice, or the removal of tissue. The clinical and experimental methods and results of a variety of non-invasive treatment modalities on back pain have been described and discussed in detail below.
Abstract
At present, there is an increasing international trend towards evidence-based health care. The field of low back pain (LBP) research in primary care is an excellent example of evidence-based health care because there is a huge body of evidence from randomized trials. These trials have been summarized in a large number of systematic reviews. This paper summarizes the best available evidence from systematic reviews conducted within the framework of the Cochrane Back Review Group on non-invasive treatments for non-specific LBP. Data were gathered from the latest Cochrane Database of Systematic Reviews 2005, Issue 2. The Cochrane reviews were updated with additional trials, if available. Traditional NSAIDs, muscle relaxants, and advice to stay active are effective for short-term pain relief in acute LBP. Advice to stay active is also effective for long-term improvement of function in acute LBP. In chronic LBP, various interventions are effective for short-term pain relief, i.e. antidepressants, COX2 inhibitors, back schools, progressive relaxation, cognitive�respondent treatment, exercise therapy, and intensive multidisciplinary treatment. Several treatments are also effective for short-term improvement of function in chronic LBP, namely COX2 inhibitors, back schools, progressive relaxation, exercise therapy, and multidisciplinary treatment. There is no evidence that any of these interventions provides long-term effects on pain and function. Also, many trials showed methodological weaknesses, effects are compared to placebo, no treatment or waiting list controls, and effect sizes are small. Future trials should meet current quality standards and have adequate sample size.
Keywords: Non-specific low back pain, Non-invasive treatment, Primary care, Effectiveness, Evidence review
Introduction
Low back pain is most commonly treated in primary health care settings. Clinical management of acute as well as chronic low back pain (LBP) varies substantially among health care providers. Also, many different primary health care professionals are involved in the management of LBP, such as general practitioners, physical therapists, chiropractors, osteopaths, manual therapists, and others. There is a need to increase consistency in the management of LBP across professions.
At present, there is an increasing international trend towards evidence-based health care. Within the framework of evidence-based health care, clinicians should conscientiously, explicitly, and judiciously use the best current evidence in making decisions about the care of individual patients. The field of LBP research in primary care is an excellent example of evidence-based health care because there is a huge body of evidence. At present, more than 500 randomized controlled trials (RCTs) have been published, evaluating all types of conservative and alternative treatments for LBP that are commonly used in primary care. These trials have been summarized in a large number of systematic reviews. The Cochrane Back Review Group (CBRG) offers a framework for conducting and publishing systematic reviews in the fields of back and neck pain. However, method guidelines have also been developed and published by the CBRG to improve the quality of reviews in this field and to facilitate comparison across reviews and enhance consistency among reviewers. This paper summarizes the best available evidence from systematic reviews conducted within the framework of the CBRG on non-invasive treatments for non-specific LBP.
Objectives
To determine the effectiveness of non-invasive (pharmaceutical and non-pharmaceutical) interventions compared to placebo (or sham treatment, no intervention and waiting list control) or other interventions for acute, subacute, and chronic non-specific LBP. Trials comparing various types of the same interventions (e.g. various types of NSAIDs or various types of exercises) were excluded. The evidence on complementary and alternative medicine interventions (acupuncture, botanical medicines, massage, and neuroreflexotherapy) has been published elsewhere. Evidence on surgical and other invasive interventions for LBP will be presented in another paper in the same issue of the European Spine Journal.
Methods
The results of systematic reviews conducted within the framework of the CBRG were used. Most of these reviews were published, but preliminary results from one Cochrane review on patient education (A. Engers et al., submitted for publication) that has been submitted for publication were also used. Because no Cochrane review was available, we used two recently published systematic reviews for the evidence summary on antidepressants. The Cochrane review on work conditioning, work hardening, and functional restoration was not taken into account because all trials included in this review were also included in the reviews on exercise therapy and multidisciplinary treatment. The Cochrane reviews were updated with additional trials, if available, using Clinical Evidence as source (www.clinicalevidence.com). This manuscript consists of two parts: one on evidence of pharmaceutical interventions and the other on evidence of non-pharmaceutical interventions for non-specific LBP.
Search Strategy and Study Selection
The following search strategy was used in the Cochrane reviews:
A computer aided search of the Medline and Embase databases since their beginning.
A search of the Cochrane Central Register of Controlled Trials (Central).
Screening references given in relevant systematic reviews and identified trials.
Personal communication with content experts in the field.
Two reviewers independently applied the inclusion criteria to select the potentially relevant trials from the titles, abstracts, and keywords of the references retrieved by the literature search. Articles for which disagreement existed, and articles for which title, abstract, and keywords provided insufficient information for a decision on selection were obtained to assess whether they met the inclusion criteria. A consensus method was used to resolve disagreements between the two reviewers regarding the inclusion of studies. A third reviewer was consulted if disagreements were not resolved in the consensus meeting.
Inclusion Criteria
Study design. RCTs were included in all reviews.
Participants. Participants of trials that were included in the systematic reviews usually had acute (less than 6 weeks), subacute (6�12 weeks), and/or chronic (12 weeks or more) LBP. All reviews included patients with non-specific LBP.
Interventions. All reviews included one specific intervention. Typically any comparison group was allowed, but comparisons with no treatment/placebo/waiting list controls and other interventions were separately presented.
Outcomes. The outcome measures included in the systematic reviews were outcomes of symptoms (e.g. pain), overall improvement or satisfaction with treatment, function (e.g. back-specific functional status), well-being (e.g. quality of life), disability (e.g. activities of daily living, work absenteeism), and side effects. Results were separately presented for short-term and long-term follow-up.
Methodological Quality Assessment
In most reviews, the methodological quality of trials included in the reviews was assessed using the criteria recommended by the CBRG. The studies were not blinded for authors, institutions, or the journals in which the studies were published. The criteria were: (1) adequate allocation concealment, (2) adequate method of randomization, (3) similarity of baseline characteristics, (4) blinding of patients, (5) blinding of care provider, (6) equal co-interventions, (7) adequate compliance, (8) identical timing of outcome assessment, (9) blinded outcome assessment, (10) withdrawals and drop outs adequate, and (11) intention-to-treat analysis. All items were scored as positive, negative, or unclear. High quality was typically defined as fulfilling 6 or more of the 11 quality criteria. We refer readers to the original Cochrane reviews for details of the quality of trials.
Data Extraction
The data that were extracted and presented in tables included characteristics of participants, interventions, outcomes, and results. We refer readers to the original Cochrane reviews for summaries of trial data.
Data Analysis
Some reviews conducted a meta-analysis using statistical methods to analyse and summarize the data. If relevant valid data were lacking (data were too sparse or of inadequate quality) or if data were statistically too heterogeneous (and the heterogeneity could not be explained), statistical pooling was avoided. In these cases, reviewers performed a qualitative analysis. In the qualitative analyses, various levels of evidence were used that took into account the participants, interventions, outcomes, and methodological quality of the original studies. If only a subset of available trials provided sufficient data for inclusion in a meta-analysis (e.g. only some trials reported standard deviations), both a quantitative and qualitative analysis was used.
Dr. Alex Jimenez’s Insight
The purpose of the following research study was to determine which of the various non-invasive treatment modalities used could be safe and most effective towards the prevention, diagnosis and treatment of acute, subacute and chronic non-specific low back pain, as well as general back pain. All of the systematic reviews included participants with some type of non-specific low back pain, or LBP, where each received health care for one specific intervention. The outcome measures included in the systematic reviews were based on symptoms, overall improvement or satisfaction with treatment, function, well-being, disability and side effects. The data of the results was extracted and presented in Tables 1 and 2. The researchers of the study performed a qualitative analysis of all the presented clinical and experimental data before demonstrating it in this article. As a healthcare professional, or patient with back pain, the information in this research study may help determine which non-invasive treatment modality should be considered to achieve the desired recovery outcome measures.
Results
Pharmaceutical Interventions
Antidepressants
There are three reasons for using antidepressants in the treatment of LBP. The first reason is that chronic LBP patients often also cope with depression, and treatment with antidepressants may elevate mood and increase pain tolerance. Second, many antidepressant drugs are sedating, and it has been suggested that part of their value for managing chronic pain syndromes simply could be improving sleep. The third reason for the use of antidepressants in chronic LBP patients is their supposed analgesic action, which occurs at lower doses than the antidepressant effect.
Effectiveness of antidepressants for acute LBP No trials were identified.
Effectiveness of antidepressants for chronic LBP Antidepressants versus placebo. We found two systematic reviews including a total of nine trials. One review found that antidepressants significantly increased pain relief compared with placebo but found no significant difference in functioning [pain: standardized mean difference (SMD) 0.41, 95% CI 0.22�0.61; function: SMD 0.24, 95% CI -0.21 to +0.69]. The other review did not statistically pool data but had similar results.
Adverse effects Adverse effects of antidepressants include dry mouth, drowsiness, constipation, urinary retention, orthostatic hypotension, and mania. One RCT found that the prevalence of dry mouth, insomnia, sedation, and orthostatic symptoms was 60�80% with tricyclic antidepressants. However, rates were only slightly lower in the placebo group and none of the differences were significant. In many trials, the reporting of side effects was insufficient.
Muscle Relaxants
The term �muscle relaxants� is very broad and includes a wide range of drugs with different indications and mechanisms of action. Muscle relaxants can be divided into two main categories: antispasmodic and antispasticity medications.
Antispasmodics are used to decrease muscle spasm associated with painful conditions such as LBP. Antispasmodics can be subclassified into benzodiazepines and non-benzodiazepines. Benzodiazepines (e.g. diazepam, tetrazepam) are used as anxiolytics, sedatives, hypnotics, anticonvulsants, and/or skeletal muscle relaxants. Non-benzodiazepines include a variety of drugs that can act at the brain stem or spinal cord level. The mechanisms of action with the central nervous system are still not completely understood.
Antispasticity medications are used to reduce spasticity that interferes with therapy or function, such as in cerebral palsy, multiple sclerosis, and spinal cord injuries. The mechanism of action of the antispasticity drugs with the peripheral nervous system (e.g. dantrolene sodium) is the blockade of the sarcoplasmic reticulum calcium channel. This reduces calcium concentration and diminishes actin�myosin interaction.
Effectiveness of muscle relaxants for acute LBP Benzodiazepines versus placebo. One study showed that there is limited evidence (one trial; 50 people) that an intramuscular injection of diazepam followed by oral diazepam for 5 days is more effective than placebo for patients with acute LBP on short-term pain relief and better overall improvement, but is associated with substantially more central nervous system side effects.
Non-benzodiazepines versus placebo. Eight studies were identified. One high quality study on acute LBP showed that there is moderate evidence (one trial; 80 people) that a single intravenous injection of 60 mg orphenadrine is more effective than placebo in immediate relief of pain and muscle spasm for patients with acute LBP.
Three high quality and one low quality trial showed that there is strong evidence (four trials; 294 people) that oral non-benzodiazepines are more effective than placebo for patients with acute LBP on short-term pain relief, global efficacy, and improvement of physical outcomes. The pooled RR and 95% CIs for pain intensity was 0.80 (0.71�0.89) after 2�4 days (four trials; 294 people) and 0.58 (0.45�0.76) after 5�7 days follow-up (three trials; 244 people). The pooled RR and 95% CIs for global efficacy was 0.49 (0.25�0.95) after 2�4 days (four trials; 222 people) and 0.68 (0.41�1.13) after 5�7 days follow-up (four trials; 323 people).
Antispasticity drugs versus placebo. Two high quality trials showed that there is strong evidence (two trials; 220 people) that antispasticity muscle relaxants are more effective than placebo for patients with acute LBP on short-term pain relief and reduction of muscle spasm after 4 days. One high quality trial also showed moderate evidence on short-term pain relief, reduction of muscle spasm, and overall improvement after 10 days.
Effectiveness of muscle relaxants for chronic LBP Benzodiazepines versus placebo. Three studies were identified. Two high quality trials on chronic LBP showed that there is strong evidence (two trials; 222 people) that tetrazepam 50 mg t.i.d. is more effective than placebo for patients with chronic LBP on short-term pain relief and overall improvement. The pooled RRs and 95% CIs for pain intensity were 0.82 (0.72�0.94) after 5�7 days follow-up and 0.71 (0.54�0.93) after 10�14 days. The pooled RR and 95% CI for overall improvement was 0.63 (0.42�0.97) after 10�14 days follow-up. One high quality trial showed that there is moderate evidence (one trial; 50 people) that tetrazepam is more effective than placebo on short-term decrease of muscle spasm.
Non-benzodiazepines versus placebo. Three studies were identified. One high quality trial showed that there is moderate evidence (one trial; 107 people) that flupirtin is more effective than placebo for patients with chronic LBP on short-term pain relief and overall improvement after 7 days, but not on reduction of muscle spasm. One high quality trial showed that there is moderate evidence (one trial; 112 people) that tolperisone is more effective than placebo for patients with chronic LBP on short-term overall improvement after 21 days, but not on pain relief and reduction of muscle spasm.
Adverse effects Strong evidence from all eight trials on acute LBP (724 people) showed that muscle relaxants are associated with more total adverse effects and central nervous system adverse effects than placebo, but not with more gastrointestinal adverse effects; RRs and 95% CIs were 1.50 (1.14�1.98), 2.04 (1.23�3.37), and 0.95 (0.29�3.19), respectively. The most commonly and consistently reported adverse events involving the central nervous system were drowsiness and dizziness. For the gastrointestinal tract this was nausea. The incidence of other adverse events associated with muscle relaxants was negligible.
NSAIDs
The rationale for the treatment of LBP with NSAIDs is based both on their analgesic potential and their anti-inflammatory action.
Effectiveness of NSAIDs for acute LBP NSAIDs versus placebo. Nine studies were identified. Two studies reported on LBP without radiation, two on sciatica, and the other five on a mixed population. There was conflicting evidence that NSAIDs provide better pain relief than placebo in acute LBP. Six of the nine studies which compared NSAIDs with placebo for acute LBP reported dichotomous data on global improvement. The pooled RR for global improvement after 1 week using the fixed effects model was 1.24 (95% CI 1.10�1.41), indicating a statistically significant effect in favour of NSAIDs compared to placebo. The pooled RR (three trials) for analgesic use using the fixed effects model was 1.29 (95% CI 1.05�1.57), indicating significantly less use of analgesics in the NSAIDs group.
NSAIDs versus paracetamol/acetaminophen. There were no differences between NSAIDs and paracetamol reported in two studies, but one study reported better outcomes for two of the four types of NSAIDs. There is conflicting evidence that NSAIDs are more effective than paracetamol for acute LBP.
NSAIDs versus other drugs. Six studies reported on acute LBP, of which five did not find any differences between NSAIDs and narcotic analgesics or muscle relaxants. Group sizes in these studies ranged from 19 to 44 and, therefore, these studies simply may have lacked power to detect a statistically significant difference. There is moderate evidence that NSAIDs are not more effective than other drugs for acute LBP.
Effectiveness of NSAIDs for chronic LBP NSAIDs versus placebo. One small cross-over study (n=37) found that naproxen sodium 275 mg capsules (two capsules b.i.d.) decreased pain more than placebo at 14 days.
COX2 inhibitors versus placebo. Four additional trials were identified. There is strong evidence that COX2 inhibitors (etoricoxib, rofecoxib and valdecoxib) decreased pain and improved function compared with placebo at 4 and 12 weeks, but effects were small.
Adverse effects NSAIDs may cause gastrointestinal complications. Seven of the nine studies which compared NSAIDs with placebo for acute LBP reported data on side effects. The pooled RR for side effects using the fixed effects model was 0.83 (95% CI 0.64�1.08), indicating no statistically significant difference. One systematic review of the harms of NSAIDs found that ibuprofen and diclofenac had the lowest gastrointestinal complication rate, mainly because of the low doses used in practice (pooled OR for adverse effects vs. placebo 1.30, 95% CI 0.91�1.80). COX2 inhibitors have been shown to have less gastrointestinal side effects in osteoarthritis and rheumatoid arthritis studies. However, increased cardiovascular risk (myocardial infarction and stroke) has been reported with long-term use.
Non-Pharmaceutical Interventions
Advice to Stay Active
Effectiveness of advice to stay active for acute LBP Stay active versus bed rest. The Cochrane review found four studies that compared advice to stay active as single treatment with bed rest. One high quality study showed that advice to stay active significantly improved functional status and reduced sick leave after 3 weeks compared with advice to rest in bed for 2 days. It also found a significant reduction of pain intensity in favour of the stay active group at intermediate follow-up (more than 3 weeks). The low quality studies showed conflicting results. The additional trial (278 people) found no significant differences in pain intensity and functional disability between advice to stay active and bed rest after 1 month. However, it found that advice to stay active significantly reduced sick leave compared with bed rest up to day 5 (52% with advice to stay active vs. 86% with bed rest; P<0.0001).
Stay active versus exercise. One trial found short-term improvement in functional status and reduction in sick leave in favour of advice to stay active. A significant reduction in sick leave in favour of the stay active group was also reported at long-term follow-up.
Effectiveness of advice to stay active for chronic LBP No trials identified.
Adverse effects No trials reported side effects.
Back Schools
The original �Swedish back school� was introduced by Zachrisson Forsell in 1969. It was intended to reduce the pain and prevent recurrences. The Swedish back school consisted of information on the anatomy of the back, biomechanics, optimal posture, ergonomics, and back exercises. Four small group sessions were scheduled during a 2-week period, with each session lasting 45 min. The content and length of back schools has changed and appears to vary widely today.
Effectiveness of back schools for acute LBP Back schools versus waiting list controls or �placebo� interventions. Only one trial compared back school with placebo (shortwaves at the lowest intensity) and showed better short-term recovery and return to work for the back school group. No other short- or long-term differences were found.
Back schools versus other interventions. Four studies (1,418 patients) showed conflicting evidence on the effectiveness of back schools compared to other treatments for acute and subacute LBP on pain, functional status, recovery, recurrences, and return to work (short-, intermediate-, and long-term follow-up).
Effectiveness of back schools for chronic LBP Back schools versus waiting list controls or �placebo� interventions. There is conflicting evidence (eight trials; 826 patients) on the effectiveness of back schools compared to waiting list controls or placebo interventions on pain, functional status, and return to work (short-, intermediate-, and long-term follow-up) for patients with chronic LBP.
Back schools versus other treatments. Six studies were identified comparing back schools with exercises, spinal or joint manipulation, myofascial therapy, and some kind of instructions or advice. There is moderate evidence (five trials; 1,095 patients) that a back school is more effective than other treatments for patients with chronic LBP for pain and functional status (short- and intermediate-term follow-up). There is moderate evidence (three trials; 822 patients) that there is no difference in long-term pain and functional status.
Adverse effects None of the trials reported any adverse effects.
Bed Rest
One rationale for bed rest is that many patients experience relief of symptoms in a horizontal position.
Effectiveness of bed rest for acute LBP Twelve trials were included in the Cochrane review. Some trials were on a mixed population of patients with acute and chronic LBP or on a population of patients with sciatica.
Bed rest versus advice to stay active. Three trials (481 patients) were included in this comparison. The results of two high quality trials showed small but consistent and significant differences in favour of staying active, at 3- to 4-week follow-up [pain: SMD 0.22 (95% CI 0.02�0.41); function: SMD 0.31 (95% CI 0.06�0.55)], and at 12-week follow-up [pain: SMD 0.25 (95% CI 0.05�0.45); function: SMD 0.25 (95% CI 0.02�0.48)]. Both studies also reported significant differences in sick leave in favour of staying active. There is strong evidence that advice to rest in bed is less effective than advice to stay active for reducing pain and improving functional status and speeding-up return to work.
Bed rest versus other interventions. Three trials were included. Two trials compared advice to rest in bed with exercises and found strong evidence that there was no difference in pain, functional status, or sick leave at short- and long-term follow-up. One study found no difference in improvement on a combined pain, disability, and physical examination score between bed rest and manipulation, drug therapy, physiotherapy, back school, or placebo.
Short bed rest versus longer bed rest. One trial in patients with sciatica reported no significant difference in pain intensity between 3 and 7 days of bed rest, measured 2 days after the end of treatment.
Effectiveness of bed rest for chronic LBP There were no trials identified.
Adverse effects No trials reported adverse effects.
Behavioural Treatment
The treatment of chronic LBP not only focuses on removing the underlying organic pathology, but also tries to reduce disability through the modification of environmental contingencies and cognitive processes. In general, three behavioural treatment approaches can be distinguished: operant, cognitive, and respondent. Each of these approaches focus on the modification of one of the three response systems that characterize emotional experiences: behaviour, cognition, and physiological reactivity.
Operant treatments include positive reinforcement of healthy behaviours and consequent withdrawal of attention towards pain behaviours, time-contingent instead of pain-contingent pain management, and spousal involvement. The operant treatment principles can be applied by all health care disciplines involved with the patient.
Cognitive treatment aims to identify and modify patients� cognitions regarding their pain and disability. Cognition (the meaning of pain, expectations regarding control over pain) can be modified directly by cognitive restructuring techniques (such as imagery and attention diversion), or indirectly by the modification of maladaptive thoughts, feelings, and beliefs.
Respondent treatment aims to modify the physiological response system directly, e.g. by reduction of muscular tension. Respondent treatment includes providing the patient with a model of the relationship between tension and pain, and teaching the patient to replace muscular tension by a tension-incompatible reaction, such as the relaxation response. Electromyographic (EMG) biofeedback, progressive relaxation, and applied relaxation are frequently used.
Behavioural techniques are often applied together as part of a comprehensive treatment approach. This so-called cognitive�behavioural treatment is based on a multidimensional model of pain that includes physical, affective, cognitive, and behavioural components. A large variety of behavioural treatment modalities are used for chronic LBP because there is no general consensus about the definition of operant and cognitive methods. Furthermore, behavioural treatment often consists of a combination of these modalities or is applied in combination with other therapies (such as medication or exercises).
Effectiveness of behavioural therapy for acute LBP One RCT (107 people) identified by the review found that cognitive�behavioural therapy reduced pain and perceived disability after 9�12 months compared with traditional care (analgesics plus back exercises until pain had subsided).
Effectiveness of behavioural therapy for chronic LBP Behavioural treatment versus waiting list controls. There is moderate evidence from two small trials (total of 39 people) that progressive relaxation has a large positive effect on pain (1.16; 95% CI 0.47�1.85) and behavioural outcomes (1.31; 95% CI 0.61�2.01) in the short-term. There is limited evidence that progressive relaxation has a positive effect on short-term back-specific and generic functional status.
There is moderate evidence from three small trials (total of 88 people) that there is no significant difference between EMG biofeedback and waiting list control on behavioural outcomes in the short-term. There is conflicting evidence (two trials; 60 people) on the effectiveness of EMG versus waiting list control on general functional status.
There is conflicting evidence from three small trials (total of 153 people) regarding the effect of operant therapy on short-term pain intensity, and moderate evidence that there is no difference [0.35 (95% CI -0.25 to 0.94)] between operant therapy and waiting list control for short-term behavioural outcomes. Five studies compared combined respondent and cognitive therapy with waiting list controls. There is strong evidence from four small trials (total of 134 people) that combined respondent and cognitive therapy has a medium sized, short-term positive effect on pain intensity. There is strong evidence that there are no differences [0.44 (95% CI -0.13 to 1.01)] on short-term behavioural outcomes.
Behavioural treatment versus other interventions. There is limited evidence (one trial; 39 people) that there are no significant differences between behavioural treatment and exercise on pain intensity, generic functional status and behavioural outcomes, either post-treatment, or at 6- or 12-month follow-up.
Adverse effects None reported in the trials.
Exercise Therapy
Exercise therapy is a management strategy that is widely used in LBP; it encompasses a heterogeneous group of interventions ranging from general physical fitness or aerobic exercise, to muscle strengthening, to various types of flexibility and stretching exercises.
Effectiveness of exercise therapy for acute LBP Exercise versus no treatment. The pooled analysis failed to show a difference in short-term pain relief between exercise therapy and no treatment, with an effect of -0.59 points/100 (95% CI -12.69 to 11.51).
Exercise versus other interventions. Of 11 trials involving 1,192 adults with acute LBP, 10 had non-exercise comparisons. These trials provide conflicting evidence. The pooled analysis showed that there was no difference at the earliest follow-up in pain relief when compared to other conservative treatments: 0.31 points (95% CI -0.10 to 0.72). Similarly, there was no significant positive effect of exercise on functional outcomes. Outcomes show similar trends at short-, intermediate-, and long-term follow-up.
Effectiveness of exercise therapy for subacute LBP Exercise versus other interventions. Six studies involving 881 subjects had non-exercise comparisons. Two trials found moderate evidence of reduced work absenteeism with a graded activity intervention compared to usual care. The evidence is conflicting regarding the effectiveness of other exercise therapy types in subacute LBP compared to other treatments.
Effectiveness of exercise therapy for chronic LBP Exercise versus other interventions. Thirty-three exercise groups in 25 trials on chronic LBP had non-exercise comparisons. These trials provide strong evidence that exercise therapy is at least as effective as other conservative interventions for chronic LBP. Two exercise groups in high quality studies and nine groups in low quality studies found exercise more effective than comparison treatments. These studies, mostly conducted in health care settings, commonly used exercise programs that were individually designed and delivered (as opposed to independent home exercises). The exercise programs commonly included strengthening or trunk stabilizing exercises. Conservative care in addition to exercise therapy was often included in these effective interventions, including behavioural and manual therapy, advice to stay active, and education. One low quality trial found a group-delivered aerobics and strengthening exercise program resulted in less improvement in pain and function outcomes than behavioural therapy. Of the remaining trials, 14 (2 high quality and 12 low quality) found no statistically significant or clinically important differences between exercise therapy and other conservative treatments; 4 of these trials were inadequately powered to detect clinically important differences on at least one outcome. Trials were rated low quality most commonly because of inadequate assessor blinding.
Meta-analysis of pain outcomes at the earliest follow-up included 23 exercise groups with an independent comparison and adequate data. Synthesis resulted in a pooled weighted mean improvement of 10.2 points (95% CI 1.31�19.09) for exercise therapy compared to no treatment, and 5.93 points (95% CI 2.21�9.65) compared to other conservative treatment [vs. all comparisons 7.29 points (95% CI 3.67�0.91)]. Smaller improvements were seen in functional outcomes with an observed mean positive effect of 3.15 points (95% CI -0.29 to 6.60) compared to no treatment, and 2.37 points (95% CI 0.74�4.0) versus other conservative treatment at the earliest follow-up [vs. all comparisons 2.53 points (95% CI 1.08�3.97)].
Adverse effects Most trials did not report any side effects. Two studies reported cardiovascular events that were considered not to be caused by the exercise therapy.
Lumbar Supports
Lumbar supports are provided as treatment to people suffering from LBP with the aim of making the impairment and disability vanish or decrease. Different desired functions have been suggested for lumbar supports: (1) to correct deformity, (2) to limit spinal motion, (3) to stabilize part of the spine, (4) to reduce mechanical uploading, and (5) miscellaneous effects: massage, heat, placebo. However, at the present time the putative mechanisms of action of a lumbar support remain a matter of debate.
Effectiveness of lumbar supports for acute LBP No trials were identified.
Effectiveness of lumbar supports for chronic LBP No RCT compared lumbar supports with placebo, no treatment, or other treatments for chronic LBP.
Effectiveness of lumbar supports for a mixed population of acute, subacute, and chronic LBP Four studies included a mix of patients with acute, subacute, and chronic LBP. One study did not give any information about the duration of the LBP complaints of the patients. There is moderate evidence that a lumbar support is not more effective in reducing pain than other types of treatment. Evidence on overall improvement and return to work was conflicting.
Adverse effects Potential adverse effects associated with prolonged lumbar support use include decreased strength of the trunk musculature, a false sense of security, heat, skin irritation, skin lesions, gastrointestinal disorders and muscle wasting, higher blood pressure and higher heart rates, and general discomfort.
Multidisciplinary Treatment Programmes
Multidisciplinary treatments for back pain evolved from pain clinics. Initially, multidisciplinary treatments focused on a traditional biomedical model and in the reduction of pain. Current multidisciplinary approaches to chronic pain are based on a multifactorial biopsychosicial model of interrelating physical, psychological, and social/occupational factors. The content of multidisciplinary programs varies widely and, at present, it is unclear what the optimal content is and who should be involved.
Effectiveness of multidisciplinary treatment for subacute LBP No trials identified.
Effectiveness of multidisciplinary treatment for subacute LBP Multidisciplinary treatment versus usual care. Two RCTs on subacute LBP were included. The study population in both studies consisted of workers on sick leave. In one study the patients in the intervention group returned to work sooner (10 weeks) compared with the control group (15 weeks) (P=0.03). The intervention group also had fewer sick leave during follow-up than the control group (mean difference=-7.5 days, 95% CI -15.06 to 0.06). There was no statistically significant difference in pain intensity between the intervention and control group, but subjective disability had decreased significantly more in the intervention group than in the control group (mean difference=-1.2, 95% CI -1.984 to -0.416). In the other study, the median duration of absence from regular work was 60 days for the group with a combination of occupational and clinical intervention, 67 days with the occupational intervention group, 131 days with the clinical intervention group, and 120.5 days with the usual care group (P=0.04). Return to work was 2.4 times faster in the group with both an occupational and clinical intervention (95% CI 1.19�4.89) than the usual care group, and 1.91 times faster in the two groups with occupational intervention than the two groups without occupational interventions (95% CI 1.18�3.1). There is moderate evidence that multidisciplinary treatment with a workplace visit and comprehensive occupational health care intervention is effective with regard to return to work, sick leave, and subjective disability for patients with subacute LBP.
Effectiveness of multidisciplinary treatment for chronic LBP Multidisciplinary treatment versus other interventions. Ten RCTs with a total of 1,964 subjects were included in the Cochrane review. Three additional papers reported on long-term outcomes of two of these trials. All ten trials excluded patients with significant radiculopathy or other indication for surgery. There is strong evidence that intensive multidisciplinary treatment with a functional restoration approach improves function when compared with inpatient or outpatient non-multidisciplinary treatments. There is moderate evidence that intensive multidisciplinary treatment with a functional restoration approach reduces pain when compared with outpatient non-multidisciplinary rehabilitation or usual care. There is contradictory evidence regarding vocational outcomes. Five trials evaluating less intensive multidisciplinary treatment programmes could not demonstrate beneficial effects on pain, function, or vocational outcomes when compared with non-multidisciplinary outpatient treatment or usual care. One additional RCT was found that showed no difference between multidisciplinary treatment and usual care on function and health related quality of life after 2 and 6 months.
The reviewed studies provide evidence that intensive (>100 h of therapy) MBPSR with a functional restoration approach produces greater improvements in pain and function for patients with disabling chronic LBP than non-multidisciplinary rehabilitation or usual care. Less intensive treatments did not seem effective.
Adverse effects No adverse effects were reported.
Spinal Manipulation
Spinal manipulation is defined as a form of manual therapy which involves movement of a joint past its usual end range of motion, but not past its anatomic range of motion. Spinal manipulation is usually considered as that of long lever, low velocity, non-specific type manipulation as opposed to short lever, high velocity, specific adjustment. Potential hypotheses for the working mechanism of spinal manipulation are: (1) release for the entrapped synovial folds, (2) relaxation of hypertonic muscle, (3) disruption of articular or periarticular adhesion, (4) unbuckling of motion segments that have undergone disproportionate displacement, (5) reduction of disc bulge, (6) repositioning of miniscule structures within the articular surface, (7) mechanical stimulation of nociceptive joint fibres, (8) change in neurophysiological function, and (9) reduction of muscle spasm.
Effectiveness of spinal manipulation for acute LBP Spinal manipulation versus sham. Two trials were identified. Patients receiving treatment that included spinal manipulation had statistically significant and clinically important short-term improvements in pain (10-mm difference; 95% CI 2�17 mm) compared with sham therapy. However, the improvement in function was considered clinically relevant but not statistically significant (2.8-mm difference on the Roland Morris scale; 95% CI -0.1 to 5.6).
Spinal manipulation versus other therapies. Twelve trials were identified. Spinal manipulation resulted in statistically significant more short-term pain relief compared with other therapies judged to be ineffective or possibly even harmful (4-mm difference; 95% CI 1�8 mm). However, the clinical significance of this finding is questionable. The point estimate of improvement in short-term function for treatment with spinal manipulation compared with the ineffective therapies was considered clinically significant but was not statistically significant (2.1-point difference on the Roland Morris scale; 95% CI -0.2 to 4.4). There were no differences in effectiveness between patients treated with spinal manipulation and those treated with any of the conventionally advocated therapies.
Effectiveness of spinal manipulation for chronic LBP Spinal manipulation versus sham. Three trials were identified. Spinal manipulation was statistically significantly more effective compared with sham manipulation on short-term pain relief (10 mm; 95% CI 3�17 mm) and long-term pain relief (19 mm; 95% CI 3�35 mm). Spinal manipulation was also statistically significantly more effective on short-term improvement of function (3.3 points on the Roland and Morris Disability Questionnaire (RMDQ); 95% CI 0.6�6.0).
Spinal manipulation versus other therapies. Eight trials were identified. Spinal manipulation was statistically significantly more effective compared with the group of therapies judged to be ineffective or perhaps harmful on short-term pain relief (4 mm; 95% CI 0�8), and short-term improvement in function (2.6 points on the RMDQ; 95% CI 0.5�4.8). There were no differences in short- and long-term effectiveness compared with other conventionally advocated therapies such as general practice care, physical or exercise therapy, and back school.
Adverse effects In the RCTs identified by the review that used a trained therapist to select people and perform spinal manipulation, the risk of serious complications was low. An estimate of the risk of spinal manipulation causing a clinically worsened disk herniation or cauda equina syndrome in a patient presenting with lumbar disk herniation is calculated from published data to be less than 1 in 3.7 million.
Traction
Lumbar traction uses a harness (with velcro strapping) that is put around the lower rib cage and around the iliacal crest. Duration and level of force exerted through this harness can be varied in a continuous or intermittent mode. Only in motorized and bed rest traction can the force be standardized. With other techniques total body weight and the strength of the patient or therapist determine the forces exerted. In the application of traction force, consideration must be given to counterforces such as lumbar muscle tension, lumbar skin stretch and abdominal pressure, which depend on the patient�s physical constitution. If the patient is lying on the traction table, the friction of the body on the table provides the main counterforce during traction. The exact mechanism through which traction might be effective is unclear. It has been suggested that spinal elongation, through decreasing lordosis and increasing intervertebral space, inhibits nociceptive impulses, improves mobility, decreases mechanical stress, reduces muscle spasm or spinal nerve root compression (due to osteophytes), releases luxation of a disc or capsule from the zygo-apophysial joint, and releases adhesions around the zygo-apophysial joint and the annulus fibrosus. So far, the proposed mechanisms have not been supported by sufficient empirical information.
Thirteen of the studies identified in the Cochrane review included a homogeneous population of LBP patients with radiating symptoms. The remaining studies included a mix of patients with and without radiation. There were no studies exclusively involving patients who had no radiating symptoms.
Five studies included solely or primarily patients with chronic LBP of more than 12 weeks; in one study patients were all in the subacute range (4�12 weeks). In 11 studies the duration of LBP was a mixture of acute, subacute, and chronic. In four studies duration was not specified.
Effectiveness of traction for acute LBP No RCTs included primarily people with acute LBP. One study was identified that included patients with subacute LBP, but this population consisted of a mix of patients with and without radiation.
Effectiveness of traction for chronic LBP One trial found that continuous traction is not more effective on pain, function, overall improvement, or work absenteeism than placebo. One RCT (42 people) found no difference in effectiveness between standard physical therapy including continuous traction and the same program without traction. One RCT (152 people) found no significant difference between lumbar traction plus massage and interferential treatment in pain relief, or improvement of disability 3 weeks and 4 months after the end of treatment. This RCT did not exclude people with sciatica, but no further details of the proportion of people with sciatica were reported. One RCT (44 people) found that autotraction is more effective than mechanical traction on global improvement, but not on pain and function, in chronic LBP patients with or without radiating symptoms. However, this trial had several methodological problems that may be associated with biased results.
Adverse effects Little is known about the adverse effects of traction. Only a few case reports are available, which suggest that there is some danger for nerve impingement in heavy traction, i.e. lumbar traction forces exceeding 50% of the total body weight. Other risks described for lumbar traction are respiratory constraints due to the traction harness or increased blood pressure during inverted positional traction. Other potential adverse effects of traction include debilitation, loss of muscle tone, bone demineralization, and thrombophlebitis.
Transcutaneous Electrical Nerve Stimulation
Transcutaneous electrical nerve stimulation (TENS) is a therapeutic non-invasive modality mainly used for pain relief by electrically stimulating peripheral nerves via skin surface electrodes. Several types of TENS applications, differing in intensity and electrical characteristics, are used in clinical practice: (1) high frequency, (2) low frequency, (3) burst frequency, and (4) hyperstimulation.
Effectiveness of TENS for acute LBP: No trials were identified.
Effectiveness of TENS for chronic LBP The Cochrane review included two RCTs of TENS for chronic LBP. The results of one small trial (N=30) showed a significant decrease in subjective pain intensity with active TENS treatment compared to placebo over the course of the 60-min treatment session. The pain reduction seen at the end of stimulation was maintained for the entire 60-min post-treatment time interval assessed (data not shown). Longer term follow-up was not conducted in this study. The second trial (N=145) demonstrated no significant difference between active TENS and placebo for any of the outcomes measured, including pain, functional status, range of motion, and use of medical services.
Adverse effects In a third of the participants in one trial, minor skin irritation occurred at the site of electrode placement. These adverse effects were observed equally in the active TENS and placebo groups. One participant randomized to placebo TENS developed severe dermatitis 4 days after beginning therapy and was required to withdraw (Tables 1, ?2).
Table 1: Effectiveness of conservative interventions for acute non-specific low back pain.
Table 2: Effectiveness of conservative interventions for chronic non-specific low back pain.
Discussion
The best available evidence for conservative treatments for non-specific LBP summarized in this paper shows that some interventions are effective. Traditional NSAIDs, muscle relaxants, and advice to stay active are effective for short-term pain relief in acute LBP. Advice to stay active is also effective for long-term improvement of function in acute LBP. In chronic LBP, various interventions are effective for short-term pain relief, i.e. antidepressants, COX2 inhibitors, back schools, progressive relaxation, cognitive�respondent treatment, exercise therapy, and intensive multidisciplinary treatment. Several treatments are also effective for short-term improvement of function in chronic LBP, namely COX2 inhibitors, back schools, progressive relaxation, exercise therapy, and multidisciplinary treatment. There is no evidence that any of these interventions provides long-term effects on pain and function. Also, many trials showed methodological weaknesses, effects are compared to placebo, no treatment or waiting list controls, and effect sizes are small. Future trials should meet current quality standards and have adequate sample size. However, in summary, there is evidence that some interventions are effective while evidence for many other interventions is lacking or there is evidence that they are not effective.
During the last decade, various clinical guidelines on the management of acute LBP in primary care have been published that have used this evidence. At present, guidelines exist in at least 12 different countries: Australia, Denmark, Finland, Germany, Israel, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States. Since the available evidence is international, one would expect that each country�s guidelines would give more or less similar recommendations regarding diagnosis and treatment. Comparison of clinical guidelines for the management of LBP in primary care from 11 different countries showed that the content of the guidelines regarding therapeutic interventions is quite similar. However, there were also some discrepancies in recommendations across guidelines. Differences in recommendations between guidelines may be due to incompleteness of the evidence, different levels of evidence, magnitude of effects, side effects and costs, differences in health care systems (organization/financial), or differences in membership of guidelines committees. More recent guidelines may have included more recently published trials and, therefore, may end up with slightly different recommendations. Also, guidelines may have been based on systematic reviews that included trials in different languages; the majority of existing reviews have considered only studies published in a few languages, and several, only those published in English. Recommendations in guidelines are not only based on scientific evidence, but also on consensus. Guideline committees may consider various arguments differently, such as the magnitude of the effects, potential side effects, cost-effectiveness, and current routine practice and available resources in their country. Especially as we know that effects in the field of LBP, if any, are usually small and short-term effects only, interpretation of effects may vary among guideline committees. Also, guideline committees may differently weigh other aspects such as side effects and costs. The constitution of the guideline committees and the professional bodies they represent may introduce bias�either for or against a particular treatment. This does not necessarily mean that one guideline is better than the other or that one is right and the other is wrong. It merely shows that when translating the evidence into clinically relevant recommendations more aspects play a role, and that these aspects may vary locally or nationally.
Recently European guidelines for the management of LBP were developed to increase consistency in the management of non-specific LBP across countries in Europe. The European Commission has approved and funded this project called �COST B13�. The main objectives of this COST action were developing European guidelines for the prevention, diagnosis and treatment of non-specific LBP, ensuring an evidence-based approach through the use of systematic reviews and existing clinical guidelines, enabling a multidisciplinary approach, and stimulating collaboration between primary health care providers and promoting consistency across providers and countries in Europe. Representatives from 13 countries participated in this project that was conducted between 1999 and 2004. The experts represented all relevant health professions in the field of LBP: anatomy, anaesthesiology, chiropractic, epidemiology, ergonomy, general practice, occupational care, orthopaedic surgery, pathology, physiology, physiotherapy, psychology, public health care, rehabilitation, and rheumatology. Within this COST B13 project four European guidelines were developed on: (1) acute LBP, (2) chronic LBP, (3) prevention of LBP, and (4) pelvic girdle pain. The guidelines will soon be published as a supplement to the European Spine Journal.
Contributor Information
Maurits W. van Tulder, Bart Koes, Antti Malmivaara: Ncbi.nlm.nih.gov
In conclusion,�the clinical and experimental evidence above for non-invasive treatment modalities on back pain demonstrated that several of the treatments are safe and effective. While the results of a variety of the methods used to improve back pain symptoms were proven to be efficient, many other treatment modalities requires additional evidence and others were reported to not be effective towards improving symptoms of back pain.�The main objective of the research study was to determine the safest and most effective guideline for the prevention, diagnosis and treatment of non-specific back pain.�Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
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Understanding clinical and experimental evidence,�manual therapies, or manipulative therapies, are physical treatments that utilize skilled, hands-on techniques, such as manipulation and/or mobilization, used by a physical therapist, among other healthcare professionals, to diagnose and treat a variety of musculoskeletal and non-musculoskeletal injuries and conditions. Spinal manipulation/mobilization has been determined to be effective for back pain, neck pain, headache and migraine, as well as for several types of joint pain, including various other disorders in adults.
For additional notice, the following research study is a comprehensive summary of the scientific evidence regarding the effectiveness of manual therapies for the management of a variety of musculoskeletal and non-musculoskeletal injuries and conditions. The conclusions are based on the results of randomized clinical trials, widely accepted and primarily UK and United States evidence-based guidelines and the results of other randomized clinical trials not yet included.
Background
The impetus for this report stems from the media debate in the United Kingdom (UK) surrounding the scope of chiropractic care and claims regarding its effectiveness particularly for non-musculoskeletal conditions.
The domain of evidence synthesis is always embedded within the structure of societal values. What constitutes evidence for specific claims is framed by the experience, knowledge, and standards of communities. This varies substantially depending on jurisdictional restrictions by country and region. However, over the last several decades a strong international effort has been made to facilitate the systematic incorporation of standardized synthesized clinical research evidence into health care decision making.
Evidence-Based Healthcare (EBH)
EBH is about doing the right things for the right people at the right time. It does so by promoting the examination of best available clinical research evidence as the preferred process of decision making where higher quality evidence is available. This reduces the emphasis on unsystematic clinical experience and pathophysiological rationale alone while increasing the likelihood of improving clinical outcomes. The fact that randomized clinical trial (RCT) derived evidence of potentially effective interventions in population studies may not be translated in a straight forward manner to the management of individual cases is widely recognized. However, RCTs comprise the body of information best able to meet existing standards for claims of benefit from care delivery. The evidence provided by RCTs constitutes the first line of recommended action for patients and contributes, along with informed patient preference, in guiding care. Practice, as opposed to claims, is inherently interpretative within the context of patient values and ethical defensibility of recommendations. Indeed, the need to communicate research evidence, or its absence, to patients for truly informed decision-making has become an important area of health care research and clinical practice.
While some may argue that EBH is more science than art, the skill required of clinicians to integrate research evidence, clinical observations, and patient circumstances and preferences is indeed artful. It requires creative, yet informed improvisation and expertise to balance the different types of information and evidence, with each of the pieces playing a greater or lesser role depending on the individual patient and situation.
It has become generally accepted that providing evidence-based healthcare will result in better patient outcomes than non-evidence-based healthcare. The debate of whether or not clinicians should embrace an evidence-based approach has become muted. Put simply by one author: “…anyone in medicine today who does not believe in it (EBH) is in the wrong business.” Many of the criticisms of EBH were rooted in confusion over what should be done when good evidence is available versus when evidence is weak or nonexistent. From this, misunderstandings and misperceptions arose, including concerns that EBH ignores patient values and preferences and promotes a cookbook approach. When appropriately applied, EBH seeks to empower clinicians so they can develop fact-based independent views regarding healthcare claims and controversies. Importantly, it acknowledges the limitations of using scientific evidence alone to make decisions and emphasizes the importance of patients’ values and preferences in clinical decision making.
The question is no longer “should” we embrace EBH but “how”? With EBH comes the need for new skills including: efficient literature search strategies and the application of formal rules of evidence in evaluating the clinical literature. It is important to discern the role of the health care provider as an advisor who empowers informed patient decisions. This requires a healthy respect for which scientific literature to use and how to use it. “Cherry-picking” only those studies which support one’s views or relying on study designs not appropriate for the question being asked does not promote doing the right thing for the right people at the right time.
Perhaps most critical is the clinician’s willingness to change the way they practice when high quality scientific evidence becomes available. It requires flexibility born of intellectual honesty that recognizes one’s current clinical practices may not�really�be in the best interests of the patient. In some cases this will require the abandonment of treatment and diagnostic approaches once believed to be helpful. In other cases it will require the acceptance and training in new methods. The ever-evolving scientific knowledge base demands that clinicians be accepting of the possibility that what is “right” today might not be “right” tomorrow. EBH requires that clinicians’ actions are influenced by the evidence. Importantly a willingness to change must accompany the ability to keep up to date with the constant barrage of emerging scientific evidence.
Purpose
The purpose of this report is to provide a brief and succinct summary of the scientific evidence regarding the effectiveness of manual treatment as a therapeutic option for the management of a variety of musculoskeletal and non-musculoskeletal conditions based on the volume and quality of the evidence. Guidance in translating this evidence to application within clinical practice settings is presented.
Methods
For the purpose of this report, manual treatment includes spinal and extremity joint manipulation or mobilization, massage and various soft tissue techniques. Manipulation/mobilization under anaesthesia was not included in the report due to the procedure’s invasive nature. The conclusions of the report are based on the results of the most recent and most updated (spans the last five to ten years) systematic reviews of RCTs, widely accepted evidence-based clinical guidelines and/or technology assessment reports (primarily from the UK and US if available), and all RCTs not yet included in the first three categories. While critical appraisal of the included reviews and guidelines would be ideal, it is beyond the scope of the present report. The presence of discordance between the conclusions of systematic reviews is explored and described. The conclusions regarding effectiveness are based on comparisons with placebo controls (efficacy) or commonly used treatments which may or may not have been shown to be effective (relative effectiveness), as well as comparison to no treatment. The strength/quality of the evidence relating to the efficacy/effectiveness of manual treatment is graded according to an adapted version of the latest grading system developed by the US Preventive Services Task Force (see�http://www.ahrq.gov/clinic/uspstf/grades.htm). The evidence grading system used for this report is a slight modification of the system used in the 2007 Joint Clinical Practice Guideline on low back pain from the American College of Physicians and the American Pain Society.
Through a search strategy using the databases MEDLINE (PubMed), Ovid, Mantis, Index to Chiropractic Literature, CINAHL, the specialized databases Cochrane Airways Group trial registry, Cochrane Complementary Medicine Field, and Cochrane Rehabilitation Field, systematic reviews and RCTs as well as evidence-based clinical guidelines were identified. Search restrictions were human subjects, English language, peer-reviewed and indexed journals, and publications before October 2009. In addition, we screened and hand searched reference citations located in the reviewed publications. The description of the search strategy is provided in Additional file�1�(Medline search strategy).
Although findings from studies using a nonrandomized design (for example observational studies, cohort studies, prospective clinical series and case reports) can yield important preliminary evidence, the primary purpose of this report is to summarize the results of studies designed to address efficacy, relative efficacy or relative effectiveness and therefore the evidence base was restricted to RCTs. Pilot RCTs not designed or powered to assess effectiveness, and RCTs designed to test the immediate effect of individual treatment sessions were not part of the evidence base in this report.
The quality of RCTs, which have not been formally quality-assessed within the context of systematic reviews or evidence based guidelines, was assessed by two reviewers with a scale assessing the risk of bias recommended for use in Cochrane systematic reviews of RCTs. Although the Cochrane Collaboration handbook�http://www.cochrane.org/resources/handbook/�discourages that scoring be applied to the risk of bias tool, it does provide suggestion for how trials can be summarized. We have been guided by that suggestion and the adapted evidence grading system used in this report requires that we assess the validity and impact of the latest trial evidence. These additional trials are categorized as higher, moderate, or lower-quality as determined by their attributed risk of bias. For details, see Additional file�2�(The Cochrane Collaboration tool for assessing risk of bias and the rating of the bias for the purpose of this report).
The overall evidence grading system allows the strength of the evidence to be categorized into one of three categories:�high quality evidence, moderate quality evidence, and inconclusive (low quality) evidence. The operational definitions of these three categories follow below:
High quality evidence
The available evidence usually includes consistent results from well-designed, well conducted studies in representative populations which assess the effects on health outcomes.
The evidence is based on at least two consistent higher-quality (low risk of bias) randomized trials. This conclusion is therefore unlikely to be strongly affected by the results of future studies.
Moderate quality evidence
The available evidence is�sufficient�to determine the effectiveness relative to health outcomes, but confidence in the estimate is constrained by such factors as:
� The number, size, or quality of individual studies.
� Inconsistency of findings across individual studies.
� Limited generalizability of findings to routine practice.
� Lack of coherence in the chain of evidence.
The evidence is based on at least one higher-quality randomized trial (low risk of bias) with sufficient statistical power, two or more higher-quality (low risk of bias) randomized trials with some inconsistency; at least two consistent, lower-quality randomized trials (moderate risk of bias). As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion.
Inconclusive (low quality) evidence
The available evidence is�insufficient�to determine effectiveness relative to health outcomes. Evidence is insufficient because of:
� The limited number or power of studies.
� Important flaws in study design or methods (only high risk of bias studies available).
� Unexplained inconsistency between higher-quality trials.
� Gaps in the chain of evidence.
� Findings not generalizable to routine practice.
� Lack of information on important health outcomes
For the purpose of this report a determination was made whether the inconclusive evidence appears favorable or non-favorable or if a direction could even be established (unclear evidence).
Additionally, brief evidence statements are made regarding other non-pharmacological, non-invasive physical treatments (for example exercise) and patient educational interventions, shown to be effective and which can be incorporated into evidence-based therapeutic management or co-management strategies in chiropractic practices. These statements are based on conclusions of the most recent and most updated (within last five to ten years) systematic reviews of randomized clinical trials and widely accepted evidence-based clinical guidelines (primarily from the UK and US if available) identified through our search strategy.
Translating Evidence to Action
Translating evidence requires the communication of salient take-home messages in context of the user’s applications. There are two message applications for information derived from this work. First, the criteria for sufficiency of evidence differ depending on the context of the considered actions. Sufficient evidence to proffer claims of effectiveness is defined within the socio-political context�of ethics and regulation. Separate is the second application of evidence to inform decision making for individual patients. Where there is strength of evidence and the risk of bias is small, the preferred choices require little clinical judgment. Alternatively, when evidence is uncertain and/or there is higher risk of bias, then greater emphasis is placed on the patient as an active participant. This requires the clinician to effectively communicate research evidence to patients while assisting their informed decision-making.
In summary, the information derived within this report are directed to two applications 1) the determination of supportable public claims of treatment effectiveness for chiropractic care within the context of social values; and 2) the use of evidence information as a basis for individualized health care recommendations using the hierarchy of evidence (Figure 1).
Figure 1 Translating evidence to action.
Dr. Alex Jimenez’s Insight
The purpose of the research study was to provide substantial clinical and experimental evidence on the effectiveness of manual therapies, or manipulative therapies. Systematic reviews of randomized clinical trials, or RCTS, helped demonstrate the strength and quality of the evidence regarding the effectiveness of these, such as manipulation and/or mobilization. The results of the research study provide two additional purposes: to determine supportable public claims of treatment effectiveness for chiropractic care within the context of social values; and to utilize the information from the evidence as a basis for individualized healthcare recommendations using the hierarch of evidence. Detailed results of each research study method and conclusive outcome is recorded below regarding the effectiveness of manual therapies, including spinal manipulation and/or mobilization, among others.
Results
By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions (Figure 2). We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included within the identified systematic reviews and guidelines. A number of other non-invasive physical treatments and patient education with evidence of effectiveness were identified including exercise, yoga, orthoses, braces, acupuncture, heat, electromagnetic field therapy, TENS, laser therapy, cognitive behavioral therapy and relaxation. The report presents the evidence of effectiveness or ineffectiveness of manual therapy as evidence summary statements at the end of the section for each condition and in briefer summary form in Figures 3, 4, 5, 6, and 7. Additionally, definitions and brief diagnostic criteria for the conditions reviewed are provided. Diagnostic imaging for many conditions is indicated by the presence of “red flags” suggestive of serious pathology. Red flags may vary depending on the condition under consideration, but typically include fractures, trauma, metabolic disorders, infection, metastatic disease, and other pathological disease processes contraindicative to manual therapy.
Figure 2 Categories of conditions included in this report.
Figure 3 Evidence summary of spinal conditions in adults.
Figure 4 Evidence summary of extremity conditions in adults.
Figure 5 Evidence summary of headache and other conditions in adults.
Figure 6 Evidence summary of non musculoskeletal conditions in adults.
Figure 7 Evidence summary of non musculoskeletal conditions in pediatrics.
Non-specific Low Back Pain (LBP)
Definition
Non-specific LBP is defined as soreness, tension, and/or stiffness in the lower back region for which it is not possible to identify a specific cause of pain.
Diagnosis
Diagnosis of non-specific LBP is derived from the patient’s history with an unremarkable neurological exam and no indicators of potentially serious pathology. Imaging is only indicated in patients with a positive neurological exam or presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, five systematic reviews made a comprehensive evaluation of the benefit of spinal manipulation for non-specific LBP. Approximately 70 RCTs were summarized. The reviews found that spinal manipulation was superior to sham intervention and similar in effect to other commonly used efficacious therapies such as usual care, exercise, or back school. For sciatica/radiating leg pain, three reviews�found manipulation to have limited evidence. Furlan et al�concluded massage is beneficial for patients with subacute and chronic non-specific low-back pain based on a review of 13 RCTs.
Evidence-based clinical guidelines
Since 2006, four guidelines make recommendations regarding the benefits of manual therapies for the care of LBP: NICE, The American College of Physicians/American Pain Society , European guidelines for chronic LBP, and European guidelines for acute LBP. The number of RCTs included within the various guidelines varied considerably based on their scope, with the NICE guidelines including eight trials and The American College of Physicians/American Pain Society guidelines including approximately 70 trials. These guidelines in aggregate recommend spinal manipulation/mobilization as an effective treatment for acute, subacute, and chronic LBP. Massage is also recommended for the treatment of subacute and chronic LBP.
Recent randomized clinical trials not included in above
Hallegraeff et al�compared a regimen of spinal manipulation plus standard physical therapy to standard physical therapy for acute LBP. Overall there were no differences between groups for pain and disability post treatment. Prediction rules may have affected outcomes. This study had a high risk of bias.
Rasmussen et al found patients receiving extension exercise or receiving extension exercise plus spinal manipulation experienced a decrease in chronic LBP, but no differences were noted between groups. This study had a high risk of bias.
Little et al�found Alexander technique, exercise, and massage were all superior to control (normal care) at three months for chronic LBP and disability. This study had a moderate risk of bias.
Wilkey et al found chiropractic management was superior to NHS pain clinic management for chronic LBP at eight weeks for pain and disability outcomes. This study had a high risk of bias.
Bogefeldt et al found manual therapy plus advice to stay active was more effective than advice to stay active alone for reducing sick leave and improving return to work at 10 weeks for acute LBP. No differences between the groups were noted at two years. This study had a low risk of bias.
Hancock et al found spinal mobilization in addition to medical care was no more effective than medical care alone at reducing the number of days until full recovery for acute LBP. This study had a low risk of bias.
Ferreira et al found spinal manipulation was superior to general exercise for function and perceived effect at eight weeks in chronic LBP patients, but no differences were noted between groups at six and 12 months. This study had a moderate risk of bias.
Eisenberg et al found that choice of complementary therapies (including chiropractic care) in addition to usual care was no different from usual care in bothersomeness and disability for care of acute LBP. The trial did not report findings for any individual manual therapy. This study had a low risk of bias.
Hondras et al found lumbar flexion-distraction was superior to minimal medical care at 3,6,9,12, and 24 weeks for disability related to subacute or chronic LBP, but spinal manipulation was superior to minimal medical care only at three weeks. No differences between spinal manipulation and flexion-distraction were noted for any reported outcomes. Global perceived improvement was superior at 12 and 24 weeks for both manual therapies compared to minimal medical care. This study had a low risk of bias.
Mohseni-Bandpei et al showed that patients receiving manipulation/exercise for chronic LBP reported greater improvement compared with those receiving ultrasound/exercise at both the end of the treatment period and at 6-month follow-up. The study had a high risk of bias.
Beyerman et al evaluated the efficacy of chiropractic spinal manipulation, manual flexion/distraction, and hot pack application for the treatment of LBP of mixed duration from osteoarthritis (OA) compared with moist heat alone. The spinal manipulation group reported more and faster short term improvement in pain and range of motion. The study had a high risk of bias.
Poole et al showed that adding either foot reflexology or relaxation training to usual medical care in patients with chronic LBP is no more effective than usual medical care alone in either the short or long term. The study had a moderate risk of bias.
Zaproudina et al found no differences between groups (bonesetting versus exercise plus massage) at one month or one year for pain or disability. The global assessment score of improvement was superior for the bonesetting group at one month. This study had a high risk of bias.
Evidence Summary (See Figure 3)
? High quality evidence that spinal manipulation/mobilization is an effective treatment option for subacute and chronic LBP in adults.
? Moderate quality evidence that spinal manipulation/mobilization is an effective treatment option for subacute and chronic LBP in older adults.
? Moderate quality evidence that spinal manipulation/mobilization is an effective treatment option for acute LBP in adults.
? Moderate evidence that adding spinal mobilization to medical care does not improve outcomes for acute LBP in adults.
? Moderate quality evidence that massage is an effective treatment for subacute and chronic LBP in adults.
? Inconclusive evidence in a favorable direction regarding the use of manipulation for sciatica/radiating leg pain.
? Inconclusive evidence in a non-favorable direction regarding the addition of foot reflexology to usual medical care for chronic LBP.
Other effective non-invasive physical treatments or patient education
Advice to stay active, interdisciplinary rehabilitation, exercise therapy, acupuncture, yoga, cognitive-behavioral therapy, or progressive relaxation for chronic LBP and superficial heat for acute LBP.
Non-specific mid back pain
Definition
Non-specific thoracic spine pain is defined as soreness, tension, and/or stiffness in the thoracic spine region for which it is not possible to identify a specific cause of pain.
Diagnosis
Diagnosis of non-specific thoracic spine pain is derived from the patient’s history with an unremarkable neurological exam and no indicators of potentially serious pathology. Imaging is only indicated in patients with a positive neurological exam or presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
No systematic reviews addressing the role of manual therapy in thoracic spine pain that included randomized clinical trials were located.
Evidence-based clinical guidelines
The Australian acute musculoskeletal pain guidelines group concludes there is evidence from one small pilot study that spinal manipulation is effective compared to placebo for thoracic spine pain.
Recent randomized clinical trials not included in above
Multiple randomized clinical trials investigating the use of thoracic spinal manipulation were located; however, most of the trials assessed the effectiveness of thoracic manipulation for neck or shoulder pain.
Evidence Summary (See Figure 3)
? Inconclusive evidence in a favorable direction regarding the use of spinal manipulation for mid back pain.
Other effective non-invasive physical treatments or patient education
None
Mechanical neck pain
Definition
Mechanical neck pain is defined as pain in the anatomic region of the neck for which it is not possible to identify a specific pathological cause of pain. It generally includes neck pain, with or without pain in the upper limbs which may or may not interfere with activities of daily living (Grades I and II). Signs and symptoms indicating significant neurologic compromise (Grade III) or major structural pathology (Grade IV including fracture, vertebral dislocation, neoplasm, etc.) are NOT included.
Diagnosis
Diagnosis of mechanical neck pain is derived from the patient’s history. Imaging is only indicated in patients with a positive neurological exam or presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
The recently published best evidence synthesis by the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders represents the most recent and comprehensive systematic review of the literature for non-invasive interventions, including manual treatment, for neck pain. For whiplash associated disorders, they concluded that mobilization and exercises appear more beneficial than usual care or physical modalities. For Grades I and II neck pain, they concluded that the evidence suggests that manual treatment (including manipulation and mobilization) and exercise interventions, low-level laser therapy and perhaps acupuncture are more effective than no treatment, sham or alternative interventions. No one type of treatment was found to be clearly superior to any other. They also note that manipulation and mobilization yield comparable results. Conclusions regarding massage could not be made due to lack of evidence.
Since 2003, there were five other systematic reviews. One found that spinal manipulation was effective for non-specific neck pain alone and in combination with exercise, while two found effectiveness only for the combination of spinal manipulation and exercise. Differences between review conclusions are expected. It is likely they can be attributed to additional primary studies and diversity in review strategies, including inclusion criteria, methodological quality scoring, and evidence determination.
Evidence-based clinical guidelines
The American Physical Therapy Association’s guidelines on neck pain recommends utilizing cervical manipulation and mobilization procedures to reduce neck pain based on strong evidence.�They found cervical manipulation and mobilization with exercise to be more effective for reducing neck pain and disability than manipulation and mobilization alone. Thoracic spine manipulation is also recommended for reducing pain and disability in patients with neck and neck-related arm pain based on weak evidence.
Recent randomized clinical trials not included in above
H�kkinen et al used a cross-over design to compare manual therapy and stretching for chronic neck pain. Manual therapy was more effective than stretching at four weeks, but no difference between the two therapies was noted at 12 weeks. This study had a high risk of bias.
Gonz�lez-Iglesias et al examined the effectiveness of adding general thoracic spine manipulation to electrotherapy/thermal therapy for acute neck pain. In two separate trials they found an advantage for the manipulation group in terms of pain and disability. The trials had moderate to low risk of bias.
Walker et al compared manual therapy with exercise to advice to stay active and placebo ultrasound. The manual therapy group reported less pain (in the short term) and more improvement and less disability (in the long term) than the placebo group. This study had a low risk of bias.
Cleland et al�showed that thoracic spine thrust mobilization/manipulation results in a significantly greater short-term reduction in pain and disability than does thoracic non-thrust mobilization/manipulation in people with mostly subacute neck pain. The study had a low risk of bias.
Fernandez et al�found that adding thoracic manipulation to a physical therapy program was effective in treating neck pain due to whiplash injury. The study had a high risk of bias.
Savolainen et al�compared the effectiveness of thoracic manipulations with instructions for physiotherapeutic exercises for the treatment of neck pain in occupational health care. The effect of the manipulations was more favorable than the personal exercise program in treating the more intense phase of pain. The study had a moderate risk of bias.
Zaproudina et al�assessed the effectiveness of traditional bone setting (mobilization) of joints of extremities and the spine for chronic neck pain compared with conventional physiotherapy or massage. The traditional bone setting was superior to the other two treatments in both in the short and long term. The study had a moderate risk of bias.
Sherman et al compared massage therapy to self-care for chronic neck pain. Massage was superior to self-care at 4 weeks for both neck disability and pain. A greater proportion of massage patients reported a clinically significant improvement in disability than self-care patients at four weeks, and more massage patients reported a clinically significant improvement in pain at four and 10 weeks. No statistically significant differences between groups were noted at 26 weeks. This study had a low risk of bias.
Evidence Summary (See Figure 3)
? Moderate quality evidence that mobilization combined with exercise is effective for acute whiplash-associated disorders.
? Moderate quality evidence that spinal manipulation/mobilization combined with exercise is effective for chronic non-specific neck pain.
? Moderate quality evidence that thoracic spinal manipulation/mobilization is effective for acute/subacute non-specific neck pain.
? Moderate quality evidence that spinal manipulation is similar to mobilization for chronic non-specific neck pain.
? Moderate quality evidence that massage therapy is effective for non-specific chronic neck pain.
? Inconclusive evidence in a favorable direction for cervical spinal manipulation/mobilization alone for neck pain of any duration.
Other effective non-invasive physical treatments or patient education
Exercise, low-level laser therapy, acupuncture
Coccydynia
Definition
Coccydynia is defined as symptoms of pain in the region of the coccyx.
Diagnosis
Diagnosis of coccydynia is derived from the patient’s history and exam with no indicators of potentially serious pathology. Imaging is only indicated in patients with a presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
None located
Evidence-based clinical guidelines
None located
Recent randomized clinical trials not included in above
Maigne et al found manipulation was more effective than placebo for pain relief and disability in the treatment of coccydynia at one month. This study had a moderate risk of bias.
Evidence Summary (See Figure 3)
? Inconclusive evidence in a favorable direction for the use of spinal manipulation in the treatment of coccydynia.
Other effective non-invasive physical treatments or patient education
None
Shoulder pain
Definition
Shoulder pain is defined as soreness, tension, and/or stiffness in the anatomical region of the shoulder and can be secondary to multiple conditions including, but not limited to rotator cuff disease and adhesive capsulitis.
Diagnosis
Diagnosis of shoulder pain is derived mainly from the patient’s history and physical exam with no indicators of potentially serious pathology. Imaging studies are confirmatory for diagnoses of rotator cuff disorders, osteoarthritis, glenohumeral instability, and other pathologic causes of shoulder pain.
Evidence base for manual treatment
Systematic reviews (most recent)
Two systematic reviews evaluated the benefit of manual therapy for shoulder pain. Six RCTs evaluating the effectiveness of manual therapy for the treatment of shoulder pain were included. Five of the trials evaluated mobilization�while one trial evaluated the use of manipulation and mobilization�for shoulder pain. The review concluded there is weak evidence that mobilization added benefit to exercise for rotator cuff disease.
Evidence-based clinical guidelines
The Philadelphia Panel’s evidence based clinical practice guidelines on selected rehabilitation interventions for shoulder pain concluded there is insufficient evidence regarding the use of therapeutic massage for shoulder pain.
Recent randomized clinical trials not included in above
Vermeulen et al�found that high-grade mobilization techniques were more effective than low-grade mobilization techniques for active range of motion (ROM), passive ROM, and shoulder disability for adhesive capsulitis at three to 12 months. No differences were noted for pain or mental and physical general health. Both groups showed improvement in all outcome measures. This study had low risk of bias.
van den Dolder and Roberts�found massage was more effective than no treatment for pain, function, and ROM over a two week period in patients with shoulder pain. This study had moderate risk of bias.
Bergman et al�found no differences between groups during the treatment period (6 wks). More patients reported being “recovered” in the usual care plus manipulative/mobilization group at 12 and 52 weeks compared to usual care alone. This study had low risk of bias.
Johnson et al�found no differences in pain or disability between anterior and posterior mobilization for the care of adhesive capsulitis. This study had a high risk of bias.
Guler-Uysal et al�concluded that deep friction massage and mobilization exercises was superior in the short term to physical therapy including diathermy for adhesive capsulitis. The study had a high risk of bias.
? Moderate quality evidence that high-grade mobilization is superior to low-grade mobilization for reduction of disability, but not for pain, in adhesive capsulitis.
? Inconclusive evidence in an unclear direction for a comparison of anterior and posterior mobilization for adhesive capsulitis.
? Moderate evidence favors the addition of manipulative/mobilization to medical care for shoulder girdle pain and dysfunction.
? Inconclusive evidence in a favorable direction for massage in the treatment of shoulder pain.
? Inconclusive evidence in a favorable direction for mobilization/manipulation in the treatment of rotator cuff pain.
Other effective non-invasive physical treatments or patient education
Exercise therapy
Lateral epicondylitis
Definition
Lateral epicondylitis is defined as pain in the region of the lateral epicondyle which is exacerbated by active and resistive movements of the extensor muscles of the forearm.
Diagnosis
Diagnosis is made solely from the patient’s history and clinical examination.
Evidence base for manual treatment
Systematic reviews (most recent)
Three systematic reviews evaluating the benefit of manual therapy for lateral epicondylitis have been identified. Eight RCTs were included�in the systematic reviews examining the effect of various manual therapies including elbow�and wrist manipulation, cervical spine�and elbow mobilization, and cross-friction massage. Bisset et al�concluded there is some evidence of positive initial effects of manual techniques (massage/mobilization) for lateral epicondylitis, but no long term evidence. Smidt et al�concluded there is insufficient evidence to draw conclusions on the effectiveness of mobilization techniques for lateral epicondylitis.
Evidence-based clinical guidelines
None located
Recent randomized clinical trials not included in above
Verhaar et al showed that corticosteroid injection was superior to Cyriax physiotherapy for the number of pain free subjects at six weeks. No differences between groups were noted at one year. This study had a high risk of bias.
Bisset et al�found corticosteroid injections were superior to elbow mobilization with exercise which was superior to wait and see approaches for pain-free grip strength, pain intensity, function, and global improvement at six weeks. However, both elbow mobilization with exercise and the wait and see approach were superior to corticosteroid injections at six months and one year for all of the previously reported outcomes. This study had a low risk of bias.
Nourbakhsh and Fearon�found oscillating energy manual therapy (tender point massage) was superior to placebo manual therapy for pain intensity and function. This study had a high risk of bias due to sample size (low risk of bias otherwise).
Evidence Summary (See Figure 4)
? Moderate quality evidence that elbow mobilization with exercise is inferior to corticosteroid injections in the short term and superior in the long term for lateral epicondylitis.
? Inconclusive evidence in a favorable direction regarding the use of manual oscillating tender point therapy of the elbow for lateral epicondylitis.
Other effective non-invasive physical treatments or patient education
Laser therapy, acupuncture
Carpal tunnel syndrome
Definition
Carpal tunnel syndrome is defined as compression of the median nerve as it passes through the carpal tunnel in the wrist.
Diagnosis
Diagnosis of carpal tunnel syndrome is made from the patient’s history, physical exam, and confirmatory electrodiagnostic tests.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2003, four systematic reviews evaluated the benefit of manual therapy for carpal tunnel syndrome. Two RCTs evaluating the effectiveness of manual therapy were included. One of the trials examined the use of spinal and upper extremity manipulation, while the other trial examined the use of wrist manipulation for carpal tunnel syndrome. The reviews concluded uncertain or limited evidence for manipulation/mobilization.
Evidence-based clinical guidelines
The American Academy of Orthopaedic Surgeons clinical practice guideline on the treatment of carpal tunnel syndrome�made no recommendations for or against the use of manipulation or massage therapy due to insufficient evidence.
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 4)
? Inconclusive evidence in a favorable direction for manipulation/mobilization in the treatment of carpal tunnel syndrome.
Other effective non-invasive physical treatments or patient education
Splinting
Hip pain
Definition
Hip pain is defined as soreness, tension, and/or stiffness in the anatomical region of the hip and can be secondary to multiple conditions including hip osteoarthritis.
Diagnosis
Diagnosis of hip pain is derived from the patient’s history and physical exam with an unremarkable neurological exam and no indicators of potentially serious pathology. Imaging studies are confirmatory for diagnoses of moderate or severe osteoarthritis.
Evidence base for manual treatment
Systematic reviews (most recent)
One systematic review evaluating manual therapy for hip pain has been published. One RCT evaluating the effectiveness of hip manipulation for the treatment of hip osteoarthritis was included in the published systematic review. The review concluded there is limited evidence for manipulative therapy combined with multimodal or exercise therapy for hip osteoarthritis.
Evidence-based clinical guidelines
The NICE national clinical guidelines for care and management of adults with osteoarthritis�recommends manipulation and stretching should be considered as an adjunct to core treatment, particularly for osteoarthritis of the hip. This recommendation is based on the results of one RCT.
The orthopaedic section of the American Physical Therapy Association’s guidelines on hip pain and mobility deficits�recommends clinicians should consider the use of manual therapy procedures to provide short-term pain relief and improve hip mobility and function in patients with mild hip osteoarthritis based on moderate evidence.
Recent randomized clinical trials not included in above
Licciardone et al found decreased rehabilitation efficiency with osteopathic manipulative therapy (OMT) compared to sham OMT following hip arthroplasty. No other significant differences were found between the two groups. This study had a high risk of bias.
Evidence Summary (See Figure 4)
? Moderate quality evidence that hip manipulation is superior to exercise for the treatment of the symptoms of hip osteoarthritis.
? Inconclusive evidence in a non-favorable direction regarding osteopathic manipulative therapy for rehabilitation following total hip arthroplasty.
Other effective non-invasive physical treatments or patient education
Exercise therapy, advice about weight loss, and appropriate footwear
Knee pain
Definition
Knee pain is defined as soreness, tension, and/or stiffness in the anatomical region of the knee and can be secondary to multiple conditions including knee osteoarthritis or patellofemoral pain syndrome.
Diagnosis
Diagnosis of knee pain is derived from the patient’s history and physical exam with an unremarkable neurological exam and no indicators of potentially serious pathology. Imaging studies are confirmatory for diagnoses of moderate or severe osteoarthritis.
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, one systematic review evaluating the benefit of manual therapy for knee pain has been identified . Ten RCT’s evaluating the effectiveness of manual therapy for the treatment of knee pain were included in the published systematic review. Both osteoarthritis knee pain and patellofemoral pain syndrome were included in the conditions reviewed. Various manual therapy techniques including spinal mobilization,�spinal manipulation, knee mobilization, and knee manipulation were examined within the review. The review concludes there is fair evidence for manipulative therapy of the knee and/or full kinetic chain (Sacro-iliac to foot), combined with multimodal or exercise therapy for knee osteoarthritis and patellofemoral pain syndrome.
Evidence-based clinical guidelines
The NICE national clinical guidelines for care and management of adults with osteoarthritis�recommends manipulation and stretching should be considered as an adjunct to core treatment.
Recent randomized clinical trials not included in above
Pollard et al�assessed a manual therapy protocol compared to non-forceful manual contact (control). They concluded that a short term of manual therapy significantly reduced pain compared to the control group. This study had a high risk of bias.
Perlman et al�found massage therapy was more effective than wait list control for osteoarthritis related knee pain, stiffness, and function. This study had a high risk of bias.
Licciardone et al�assessed osteopathic manipulative treatment following knee arthroplasty. This study found decreased rehabilitation efficiency with OMT compared to sham OMT; otherwise, no significant differences were found between the two groups. This study had a high risk of bias.
? Moderate quality evidence that manual therapy of the knee and/or full kinetic chain (SI to foot) combined with multimodal or exercise therapy is effective for the symptoms of knee osteoarthritis.
? Moderate quality evidence that manual therapy of the knee and/or full kinetic chain (SI to foot) combined with multimodal or exercise therapy is effective for patellofemoral pain syndrome.
? Inconclusive evidence in a favorable direction that massage therapy is effective for the symptoms of knee osteoarthritis.
? Inconclusive evidence in a non-favorable direction for the effectiveness of osteopathic manipulative therapy for rehabilitation following total hip or knee arthroplasty.
Other effective non-invasive physical treatments or patient education
Exercise therapy, advice about weight loss, appropriate footwear, pulsed electromagnetic field therapy, acupuncture, and TENS
Ankle and foot conditions
Definition
A variety of conditions are included under ankle and foot conditions including ankle sprains, plantar fasciitis, morton’s neuroma, hallux limitus/rigidus, and hallux abducto valgus.
Diagnosis
The diagnosis of ankle/foot conditions relies mainly on the patient’s history and physical examination. Imaging studies are indicated for morton’s neuroma or in the presence of potential pathology.
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, two systematic reviews evaluating the benefit of manual therapy for ankle and foot conditions have been published. The ankle and foot conditions reviewed included ankle sprain, plantar fasciitis, morton’s neuroma, hallux limitus, and hallux abducto valgus. Thirteen RCTs evaluating the effectiveness of manual therapy for the treatment of various ankle and foot conditions were included in the published systematic reviews. Of the thirteen trials, six examined the use of ankle/foot manipulation, six examined the use of ankle/foot mobilization, and one trial examined the combined use of manipulation and mobilization.
The review by Brantingham et al concluded there is fair evidence for manipulative therapy of the ankle and/or foot combined with multimodal or exercise therapy for ankle inversion sprain. The same authors found limited evidence for manipulative therapy combined with multimodal or exercise therapy for plantar fasciitis, metatarsalgia, and hallux limitus and insufficient evidence for the use of manual therapy for hallux abducto valgus.
The review by van der Wees et al concluded it is likely that manual mobilization has an initial effect on dorsiflexion range of motion after ankle sprains.
Evidence-based clinical guidelines
None making recommendations based on RCTs were located
Recent randomized clinical trials not included in above
Wynne et al found an osteopathic manipulative therapy group had greater improvement in plantar fasciitis symptoms versus placebo control. This study had a high risk of bias.
Cleland et al compared manual therapy with exercise to electrotherapy with exercise for patients with plantar heel pain. They found manual therapy plus exercise was superior. This study had a low risk of bias.
Lin et al found the addition of manual therapy (mobilization) to a standard physiotherapy program provided no additional benefit compared to the standard physiotherapy program alone for rehabilitation following ankle fracture. This study had a low risk of bias.
Evidence Summary (See Figure 4)
? Moderate quality evidence that mobilization is of no additional benefit to exercise in the rehabilitation following ankle fractures.
? Moderate quality evidence that manual therapy of the foot and/or full kinetic chain (SI to foot) combined with exercise therapy is effective for plantar fasciitis.
? Inconclusive evidence in a favorable direction for the effectiveness of manual therapy with multimodal or exercise therapy for ankle sprains.
? Inconclusive evidence in a favorable direction regarding the effectiveness of manual therapy for morton’s neuroma, hallux limitus, and hallux abducto valgus.
Other effective non-invasive physical treatments or patient education
Stretching and foot orthoses for plantar fasciitis, ankle supports for ankle sprains
Temporomandibular disorders
Definition
Temporomandibular disorders consist of a group of pathologies affecting the masticatory muscles, temporomandibular joint, and related structures.
Diagnosis
Diagnosis of temporomandibular disorders is derived from the patient’s history and physical exam with no indicators of potentially serious pathology.
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, two systematic reviews evaluating the benefit of manual therapy for temporomandibular dysfunction have been published. Three RCTs evaluating the effectiveness of manual therapy were included in the published systematic reviews. Two of the trials examined the effectiveness of mobilization�and one trial assessed massage. The reviews conclude there is limited evidence for the use of manual therapy in the treatment of temporomandibular dysfunction.
Evidence-based clinical guidelines
None located
Recent randomized clinical trials not included in above
Monaco et al�examined the effects of osteopathic manipulative treatment on mandibular kinetics compared to a no treatment control group; however, no between group analysis was performed. This study had a high risk of bias.
Ismail et al�found physical therapy including mobilization in addition to splint therapy was superior to splint therapy alone after three months of treatment for active mouth opening. No differences were found between groups for pain. This study had a moderate risk of bias.
? Inconclusive evidence in a favorable direction regarding mobilization and massage for temporomandibular dysfunction.
Other effective non-invasive physical treatments or patient education
None
Fibromyalgia
Definition
Fibromyalgia syndrome (FMS) is a common rheumatological condition characterized by chronic widespread pain and reduced pain threshold, with hyperalgesia and allodynia.
Diagnosis
Diagnosis of fibromyalgia is made primarily from the patient’s history and physical exam. The American College of Rheumatology have produced classification criteria for fibromyalgia including widespread pain involving both sides of the body, above and below the waist for at least three months and the presence of 11 out of 18 possible pre-specified tender points.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, three systematic reviews evaluating the benefit of manual therapy for fibromyalgia have been published. Six RCTs evaluating the effectiveness of manual therapy for the treatment of fibromyalgia were included in the published systematic reviews. Five of the studies assessed the effectiveness of spinal manipulation for fibromyalgia, while one assessed the effectiveness of massage.
Schneider et al�conclude there is moderate level evidence from several RCTs and a systematic review�that massage is helpful in improving sleep and reducing anxiety in chronic pain; however, few of the studies included in the systematic review�specifically investigated fibromyalgia.
Ernst�states that the current trial evidence is insufficient to conclude that chiropractic is an effective treatment of fibromyalgia.
Goldenberg et al�conclude there is weak evidence of efficacy for chiropractic, manual, and massage therapy in the treatment of fibromyalgia.
Evidence-based clinical guidelines
The 2007 a multidisciplinary task force with members from 11 European countries published evidence based recommendation for FMS. The task force notes the clinical trial evidence for manual therapy is lacking.
Randomized clinical trials not included in above
Ekici et al found improvement was higher in the manual lymph drainage group compared to connective tissue massage on the fibromyalgia impact questionnaire, but no differences were noted between groups for pain, pain pressure threshold, or health related quality of life. This study had a moderate risk of bias.
Evidence Summary (See Figure 5)
? Inconclusive evidence in a favorable direction regarding the effectiveness of massage and manual lymph drainage for the treatment of fibromyalgia.
? Inconclusive evidence in an unclear direction regarding the effectiveness of spinal manipulation for the treatment of fibromyalgia.
Other effective non-invasive physical treatments or patient education
Heated pool treatment with or without exercise, supervised aerobic exercise
Myofascial Pain Syndrome
Definition
Myofascial pain syndrome is a poorly defined condition that requires the presence of myofascial trigger points.
Diagnosis
Diagnosis of myofascial pain syndrome is made exclusively from the patient’s history and physical exam.
Evidence base for manual treatment
Systematic reviews (most recent)
As of September 2009, one systematic review evaluating the benefit of manual therapy for myofascial pain syndrome was identified, which concludes there is limited evidence to support the use of some manual therapies for providing long-term relief of pain at myofascial trigger points. Fifteen RCTs evaluating the effectiveness of manual therapy for the treatment of myofascial pain syndrome were included in the published systematic review. Only two of the truly randomized trials assessed the effectiveness of manual therapy beyond the immediate post-treatment period. One trial assessed the effectiveness of massage combined with other therapies, while the other trial assessed the effectiveness of self-treatment with ischemic compression.
Evidence-based clinical guidelines
None
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 5)
? Inconclusive evidence in a favorable direction regarding the effectiveness of massage for the treatment of myofascial pain syndrome.
Other effective non-invasive physical treatments or patient education
Laser, acupuncture
Migraine Headache
Definition
Migraine headache is defined as recurrent/episodic moderate or severe headaches which are usually unilateral, pulsating, aggravated by routine physical activity, and are associated with either nausea, vomiting, photophobia, or phonophobia.
Diagnosis
Diagnosis of migraine headaches is made primarily from the patient’s history and a negative neurological exam. Neuroimaging is only indicated in patients with a positive neurological exam or presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, two systematic reviews evaluated the benefit of manual therapy for migraine headache. The reviews evaluated three RCTs on spinal manipulation. Astin and Ernst�concluded that due to methodological limitations of the RCTs, it is unclear whether or not spinal manipulation is an effective treatment for headache disorders. In contrast, the conclusion from a Cochrane review�was that spinal manipulation is an effective option for the care of migraine headache. The conclusions of the two reviews differed in methodology for determining RCT quality and the strength of evidence. Astin and Ernst�evaluated study quality using a scale that is no longer recommended by the Cochrane Collaboration and did not apply evidence rules for their conclusions. The Cochrane review used a pre-specified, detailed protocol for synthesizing the evidence from the quality, quantity, and results of RCTs.
Evidence-based clinical guidelines
The SIGN guidelines�for the diagnosis and management of headache in adults concludes the evidence of effectiveness for manual therapy is too limited to lead to a recommendation.
Recent randomized clinical trials not included in above
Lawler and Cameron�found that massage therapy significantly reduced migraine frequency in the short term compared to filling out a diary with no other treatment. This study had a high risk of bias.
? Moderate quality evidence that spinal manipulation has an effectiveness similar to a first-line prophylactic prescription medication (amitriptyline) for the prophylactic treatment of migraine.
? Inconclusive evidence in a favorable direction comparing spinal manipulation to sham interferential.
? Inconclusive evidence in a favorable direction regarding the use of massage therapy alone.
Other effective non-invasive physical treatments or patient education
Tension-type headache is defined as a headache that is pressing/tightening in quality, mild/moderate in intensity, bilateral in location, and does not worsen with routine physical activity.
Diagnosis
Diagnosis of tension-type headaches is made primarily from the patient’s history and a negative neurological exam. Neuroimaging is only indicated in patients with a positive neurological exam or presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2002, five systematic reviews evaluated the benefit of manual therapy for tension-type headache. Eleven RCTs were included in the published systematic reviews. Three of the RCTs assessed the effectiveness of spinal manipulation, six of the trials evaluated the use of combined therapies including a form of manual therapy, one trial evaluated a craniosacral technique, and the remaining trial compared connective tissue manipulation to mobilization. The reviews generally conclude there is insufficient evidence to draw inference on the effectiveness of manual therapy in the treatment of tension-type headache. An exception is the Cochrane review�which found that some inference regarding spinal manipulation could be made from two trials with low risk of bias. One trial�showed that for the prophylactic treatment of chronic tension-type headache, amitriptyline (an effective drug) is more effective than spinal manipulation during treatment. However, spinal manipulation is superior in the short term after cessation of both treatments, but this could be due to a rebound effect of the medication withdrawal. The other trial�showed that spinal manipulation in addition to massage is no more effective than massage alone for the treatment of episodic tension-type headache.
Evidence-based clinical guidelines
The SIGN guideline�for the diagnosis and management of headache in adults draws no conclusions.
Recent randomized clinical trials not included in above
Anderson and Seniscal�found that participants receiving osteopathic manipulation in addition to relaxation therapy had significant improvement in headache frequency compared to relaxation therapy alone. This study had a moderate risk of bias.
Evidence Summary (See Figure 5)
? Moderate quality evidence that spinal manipulation in addition to massage is no more effective than massage alone for the treatment of episodic tension-type headache.
? Inconclusive evidence in an unclear direction regarding the use of spinal manipulation alone or in combination with therapies other than massage for most forms of tension-type headache.
Other effective non-invasive physical treatments or patient education
Acupuncture, biofeedback
Cervicogenic Headache
Definition
Cervicogenic headache is defined as unilateral or bilateral pain localized to the neck and occipital region which may project to regions on the head and/or face. Head pain is precipitated by neck movement, sustained awkward head positioning, or external pressure over the upper cervical or occipital region on the symptomatic side.
Diagnosis
Diagnosis of cervicogenic headaches is made primarily from the patient’s history and a negative neurological exam. Neuroimaging is only indicated in patients with a positive neurological exam or presence of a “red flag”.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2002, four systematic reviews have been published on manual therapy for cervicogenic headache. The reviews made inference based on six RCTs that evaluated a range of manual therapy treatments including spinal manipulation, mobilization, and friction massage. Astin and Ernst�concluded that due to methodological limitations of the RCTs, it is unclear whether or not spinal manipulation is an effective treatment for headache disorders. In contrast, a Cochrane review concluded that spinal manipulation is an effective option for the care of cervicogenic headache. The conclusions of the two reviews differed in methodology for determining RCT quality and the strength of evidence. Ernst evaluated study quality using a scale that is no longer recommended by the Cochrane Collaboration and did not apply evidence rules for their conclusions. The Cochrane review�used a pre-specified, detailed protocol for synthesizing the evidence from the quality, quantity, and results of RCTs.
Evidence-based clinical guidelines
The SIGN guidelines�for the diagnosis and management of headache in adults concluded spinal manipulation should be considered in patients with cervicogenic headache.
Recent randomized clinical trials not included in above
Hall et al�evaluated the efficacy of apophyseal glide of the upper cervical region in comparison to a sham control. They found a large clinically important and statistically significant advantage of the intervention over sham for pain intensity. The study had a low risk of bias.
? Moderate quality evidence that spinal manipulation is more effective than placebo manipulation, friction massage, and no treatment.
? Moderate quality evidence that spinal manipulation is similar in effectiveness to exercise.
? Moderate quality evidence that self-mobilizing natural apophyseal glides are more effective than placebo.
? Inclusive evidence that deep friction massage with trigger point therapy is inferior to spinal manipulation.
? Inconclusive evidence in an unclear direction for the use of mobilization.
Other effective non-invasive physical treatments or patient education
Neck exercises
Miscellaneous Headache
Definition
Headaches not classified as tension-type, migraine, or cervicogenic in nature according to the International Headache Society’s 2004 diagnostic criteria.
Evidence base for manual treatment
Systematic reviews (most recent)
One systematic review (2004) evaluated the benefit of manual therapy for other types of chronic headache. One RCT evaluating the use of mobilization for post-traumatic (post-concussive) headache was included. The review found the evidence to be inconclusive.
Evidence-based clinical guidelines
None
Recent randomized clinical trials not included in above
? Inconclusive evidence in a favorable direction regarding mobilization for post-traumatic headache.
Other effective non-invasive physical treatments or patient education
None
Asthma
Definition
Asthma is a common, complex chronic disorder of the airways that is characterized by variable and recurring symptoms, airflow obstruction, bronchial hyperresponsiveness, and an underlying inflammation.
Diagnosis
The diagnosis is made through the combination of the patient’s history, upper respiratory physical exam, and pulmonary function testing (spirometry). Patient administered peak flow measurement is often used to monitor effects of treatment.
Evidence base for manual treatment
Systematic reviews
Since 2002, four systematic reviews, one a Cochrane review, on manual therapy for asthma have been published. Of the total of five RCTs on the effectiveness of manual therapy�available from the searched literature, two investigated chiropractic spinal manipulation for chronic asthma, one in adults�and the other in children. Two trials assessed the effectiveness on chronic asthma in children, one examined osteopathic manipulative/manual therapy, and the other massage. The fifth trial evaluated the effect of foot manual reflexology for change in asthma symptoms and lung function in adults. The four systematic reviews collectively concluded that the evidence indicates that none of the manual therapy approaches have been shown to be superior to a suitable sham manual control on reducing severity and improving lung function but that clinically important improvements occur over time during both active and sham treatment.
Evidence-based clinical guidelines
The asthma guidelines by The US National Heart, Lung, and Blood Institutes�and by The British Thoracic Society�both conclude that there is insufficient evidence to recommend the use of chiropractic or related manual techniques in the treatment of asthma.
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figures 6 & 7)
? There is moderate quality evidence that spinal manipulation is not effective (similar to sham manipulation) for the treatment of asthma in children and adults on lung function and symptom severity.
? There is inconclusive evidence in a non-favorable direction regarding the effectiveness of foot manual reflexology for change in asthma symptoms and lung function in adults.
? There is inconclusive evidence in a favorable direction regarding the effectiveness of osteopathic manipulative treatment for change in asthma symptoms and lung function in children.
? There is inconclusive evidence in an unclear direction regarding the effectiveness of massage for change in asthma symptoms and lung function in children.
Other effective non-invasive physical treatments or patient education
Education and advice on self-management, maintaining normal activity levels, control of environmental factors and smoking cessation
Pneumonia
Definition
Pneumonia is defined as an acute inflammation of the lungs caused by infection.
Diagnosis
Diagnosis of pneumonia relies primarily on chest radiography in conjunction with the patient’s history, examination, and laboratory findings.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2007, one systematic review evaluating the benefit of manual therapy for pneumonia has been published. One RCT evaluating the effectiveness of manual therapy for the treatment of pneumonia was included in the published systematic review. The included trial assessed the effectiveness of osteopathic spinal manipulation for acute pneumonia in hospitalized elderly adults. The review concluded there is promising evidence for the potential benefit of manual procedures for hospitalized elderly patients with pneumonia. Our risk of bias assessment places this trial in the moderate risk of bias category.
? There is inconclusive evidence in a favorable direction regarding the effectiveness of osteopathic manual treatment for the treatment of acute pneumonia in elderly hospitalized patients.
Other effective non-invasive physical treatments or patient education
Cases of pneumonia that are of public health concern should be reported immediately to the local health department. Respiratory hygiene measures, including the use of hand hygiene and masks or tissues for patients with cough, should be used in outpatient settings as a means to reduce the spread of respiratory infections.
Vertigo
Definition
Vertigo is defined as a false sensation of movement of the self or the environment. Vertigo is a sensation and not necessarily a diagnosis as there are multiple underlying pathologies responsible for vertigo.
Diagnosis
Diagnosis of vertigo relies primarily on the patient’s history and clinical examination. Potential causes of vertigo include both pathological disorders such as vertebrobasilar insufficiency or central nervous system lesions as well as more benign causes such as cervicogenic vertigo or benign paroxysmal positional vertigo.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2004, two systematic reviews evaluating the benefit of manual therapy for vertigo have been published.�One RCT evaluating the effectiveness of mobilization and soft-tissue massage for the treatment of cervicogenic vertigo was included in both published systematic reviews. One review concluded limited evidence of effectiveness. The other concluded effectiveness, but the inference was on the inclusion of other types of evidence.
Evidence-based clinical guidelines
None addressing the use of manual therapy
Recent randomized clinical trials not included in above
Reid et al�compared sustained natural apophyseal glides (SNAGs), delivered manually by a therapist, to detuned laser treatment for the treatment of cervicogenic dizziness. Patients receiving SNAGs reported less dizziness, disability and cervical pain after six weeks, but not at 12 weeks. This study had a low risk of bias.
? Moderate quality evidence that manual treatment (specifically sustained natural apophyseal glides) is an effective treatment for cervicogenic dizziness, at least in the short term.
Other effective non-invasive physical treatments or patient education
Particle repositioning maneuvers for benign paroxysmal positional vertigo, vestibular rehabilitation
Infantile Colic
Definition
Colic is a poorly defined condition characterized by excessive, uncontrollable crying in infants.
Diagnosis
The diagnosis of colic is based solely on the patient’s history and the absence of other explanations for the excessive crying. The “rule of threes” is the most common criteria used in making a diagnosis of colic. The rule of three’s is defined as an otherwise healthy and well fed infant with paroxysms of crying and fussing lasting for a total of three hours a day and occurring more than three days a week for at least three weeks.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2003, six systematic reviews evaluating the benefit of manual therapy for infantile colic have been published. Two of the systematic reviews evaluated the effectiveness of manual therapy for non-musculoskeletal�and pediatric�conditions as a whole but fail to draw specific conclusions regarding the use of manual therapy for infantile colic. Of the eight RCTs evaluating the effectiveness of manual therapy for the treatment of colic, five were included in the published systematic reviews. All five of the trials assessed the effectiveness of chiropractic spinal manipulation for infantile colic. All four systematic reviews concluded there is no evidence manual therapy is more effective than sham therapy for the treatment of colic.
Evidence-based clinical guidelines
No clinical guidelines located
Randomized clinical trials not included in above
Hayden et al�found cranial osteopathy was more effective than no treatment for crying duration. This study had a high risk of bias
Huhtala et al�found no difference between groups treated with massage therapy or given a crib vibrator for crying duration. This study had a high risk of bias.
Arikan et al�found all four interventions (massage, sucrose solution, herbal tea, hydrolysed formula) showed improvement compared to a no treatment control group. This study had a moderate risk of bias.
Evidence Summary (See Figure 7)
? Moderate quality evidence that spinal manipulation is no more effective than sham spinal manipulation for the treatment of infantile colic.
? Inconclusive evidence in a favorable direction regarding the effectiveness of cranial osteopathic manual treatment and massage for the treatment of infantile colic.
Other effective non-invasive physical treatments or patient education
Reduce stimulation, herbal tea, and trial of hypoallergenic formula milk
Nocturnal Enuresis
Definition
Nocturnal enuresis is defined as the involuntary loss of urine at night, in the absence of organic disease, at an age when a child could reasonably be expected to be dry (typically at the age of five).
Diagnosis
The diagnosis of nocturnal enuresis is derived mainly from the patient’s history given the absence of other organic causes including congenital or acquired defects of the central nervous system. Psychological factors can be contributory in some children requiring proper assessment and treatment.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2005, two systematic reviews, one a Cochrane review, evaluating the benefit of manual therapy for nocturnal enuresis were published. The systematic reviews included a total of two randomized clinical trials. Both of the included trials examined the use of spinal manipulation for nocturnal enuresis. Both reviews concluded there is insufficient evidence to make conclusions about the effectiveness of spinal manipulation for the treatment of enuresis.
Evidence-based clinical guidelines
None addressing manual therapy as a treatment option
? Inconclusive evidence in a favorable direction regarding the effectiveness of chiropractic care for the treatment of enuresis.
Other effective non-invasive physical treatments or patient education
Education, simple behavioral interventions, and alarm treatment
Otitis Media
Definition
Otitis media is characterized by middle ear inflammation which can exist in an acute or chronic state and can occur with or without symptoms.
Diagnosis
Diagnosis of otitis media relies on otoscopic signs and symptoms consistent with a purulent middle ear effusion in association with systemic signs of illness.
Evidence base for manual treatment
Systematic reviews (most recent)
Hawk et al�found promising evidence for the potential benefit of spinal manipulation/mobilization procedures for children with otitis media. This was based on one trial. Two other reviews specifically addressed spinal manipulation by chiropractors for non-musculoskeletal�and pediatric�conditions. Both found insufficient evidence to comment on manual treatment effectiveness or ineffectiveness for otitis media.
Evidence-based clinical guidelines
The American Academy of Pediatrics 2004 guidelines on the diagnosis and management of acute otitis media�concluded no recommendation for complementary and alternative medicine for the treatment of acute otitis media can be made due to limited data.
Recent randomized clinical trials not included in above
Wahl et al investigated the efficacy of osteopathic manipulative treatment with and without Echinacea compared to sham and placebo for the treatment of otitis media. The study found that a regimen of up to five osteopathic manipulative treatments does not significantly decrease the risk of acute otitis media episodes. This study had a high risk of bias.
? Inconclusive evidence in an unclear direction regarding the effectiveness of osteopathic manipulative therapy for otitis media.
Other effective non-invasive physical treatments or patient education
Patient education and “watch and wait” approach for 72 hours for acute otitis media
Hypertension
Definition
Hypertension is defined as the sustained elevation of systolic blood pressure over 140 mmHg, diastolic blood pressure over 90 mm Hg, or both.
Diagnosis
Diagnosis of hypertension is made by the physical exam, specifically sphygmomanometry. The patient’s history, clinical exam and laboratory tests help identify potential etiologies.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2007, one systematic review evaluating the benefit of manual therapy for hypertension has been published (Hawk et al). Two RCTs evaluating the effectiveness of manual therapy for the treatment of stage I hypertension were included in this systematic review. One of the included trials evaluated the use of spinal manipulation and the other evaluated the use of instrument assisted spinal manipulation. The review found no evidence of effectiveness for spinal manipulation.
Evidence-based clinical guidelines
None addressing the use of manual therapy
Recent randomized clinical trials not included in above
A study by Bakris et al found NUCCA upper cervical manipulation to be more effective than sham manipulation in lowering blood pressure in patients with Stage I hypertension. This study had a high risk of bias.
Evidence Summary (See Figure 6)
? Moderate quality evidence that diversified spinal manipulation is not effective when added to a diet in the treatment of stage I hypertension.
? Inconclusive evidence in a favorable direction regarding upper cervical NUCCA manipulation for stage I hypertension .
? Inconclusive evidence in an unclear direction regarding instrument assisted spinal manipulation for hypertension.
Other effective non-invasive physical treatments or patient education
Advice on lifestyle interventions including diet, exercise, moderate alcohol consumption and smoking cessation
Relaxation therapies including biofeedback, meditation, or muscle relaxation
Dysmenorrhea
Definition
Dysmenorrhea is defined as painful menstrual cramps of uterine origin. Dysmenorrhea is grouped into two categories, primary and secondary dysmenorrhea. Secondary dysmenorrhea is painful menstruation associated with a pelvic pathology like endometriosis, while primary dysmenorrhea is painful menstruation in the absence of pelvic disease.
Diagnosis
Diagnosis of primary dysmenorrhea is made from the patient’s history. Diagnosis of secondary dysmenorrhea requires further investigation including a pelvic exam and potential ultrasound or laparoscopy.
Evidence base for manual treatment
Systematic reviews (most recent)
We identified two systematic reviews evaluating the benefit of manual therapy for dysmenorrhea. Five studies evaluating the effectiveness of manual therapy for the treatment of dysmenorrhea were included in the systematic reviews. Four of the included trials examined the use of spinal manipulation�and one examined the use of osteopathic manipulative techniques. Based on these trials, the Cochrane review by Proctor et al concluded there is no evidence to suggest that spinal manipulation is effective in the treatment of primary and secondary dysmenorrhea. The review by Hawk et al concluded the evidence was equivocal regarding chiropractic care for dysmenorrhea.
Evidence-based clinical guidelines
We identified consensus guidelines from the Society of Obstetricians and Gynecologists of Canada (SOGC) published in 2005 which included an assessment of manual treatment for primary dysmenorrhea. The authors concluded there is no evidence to support spinal manipulation as an effective treatment for primary dysmenorrhea.
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 7)
? Moderate quality evidence that spinal manipulation is no more effective than sham manipulation in the treatment of primary dysmenorrhea.
Other effective non-invasive physical treatments or patient education
High frequency TENS
Premenstrual Syndrome
Definition
Premenstrual syndrome is defined as distressing physical, behavioral, and psychological symptoms, in the absence of organic or underlying psychiatric disease, which regularly recurs during the luteal phase of the menstrual cycle and disappears or significantly regresses by the end of menstruation and is associated with impairment in daily functioning and/or relationships.
Diagnosis
Diagnosis of premenstrual syndrome is made through patient history and the use of a patient diary over two menstrual cycles.
Evidence base for manual treatment
Systematic reviews (most recent)
Since 2007, three systematic reviews evaluating the benefit of manual therapy for premenstrual syndrome have been published. Three RCTs evaluating the effectiveness of manual therapy for the treatment of premenstrual syndrome were included in the reviews. The included trials examined different forms of manual therapy including spinal manipulation, massage therapy, and reflexology. Overall, the reviews concluded that the evidence is “not promising”, “equivocal”, and that high quality studies are needed to draw firm conclusions.
Evidence-based clinical guidelines
None discussing manual therapy
Recent randomized clinical trials not included in above
None
Evidence Summary (See Figure 7)
? Inconclusive evidence in a favorable direction regarding the effectiveness of reflexology and massage therapy for the treatment of premenstrual syndrome.
? Inconclusive evidence in an unclear direction regarding the effectiveness of spinal manipulation for the treatment of premenstrual syndrome.
Other effective non-invasive physical treatments or patient education
Cognitive behavioral therapy
Discussion
Making claims
There are two important questions underlying the medical and media debate surrounding the scope of chiropractic care and claims regarding its effectiveness particularly for non-musculoskeletal conditions: 1) should health professionals be permitted to use generally safe but as yet unproven methods? 2) What claims, if any, can and should be made with respect to the potential value of unproven treatments?
In response to the first question, a reasonable answer is “yes” given that professionals operate within the context of EBH, where it is acknowledged what is known today, might change tomorrow. It requires flexibility born of intellectual honesty that recognizes one’s current clinical practices may not�really�be in the best interests of the patient and as better evidence emerges, clinicians are obligated to change. Further, where evidence is absent, they are open to promoting the development of new knowledge that expands understanding of appropriate health care delivery.
In response to the second question, no claims of efficacy/effectiveness should be made for which there isn’t sufficient evidence. Unsubstantiated claims can be dangerous to patient health. We maintain the best evidence for efficacy/effectiveness that meets society’s standards comes from well-designed RCTs. While other study designs and clinical observations do offer insight into the plausibility and potential value of treatments, the concepts of plausibility and evidence of efficacy/effectiveness should not be confused when making claims.
Clinical Experience versus Clinical effectiveness
Why is it that the results of RCTs often do not confirm the results observed in clinical practice? There are several reasons. One of the problems is that both the provider and the patient are likely to interpret any improvement as being solely a result of the intervention being provided. However this is seldom the case. First, the natural history of the disorder (for example. acute LBP) is expected to partially or completely resolve by itself regardless of treatment. Second, the phenomenon of regression to the mean often accounts for some of the observed improvement in the condition. Regression to the mean is a statistical phenomenon associated with the fact that patients often present to the clinic or in clinical trials at a time where they have relatively high scores on severity outcome measures. If measured repeatedly before the commencement of treatment the severity scores usually regress towards lower more normal average values.
Additionally, there is substantial evidence to show that the ritual of the patient practitioner interaction has a therapeutic effect in itself separate from any specific effects of the treatment applied. This phenomenon is termed contextual effects. The contextual or, as it is often called, non-specific effect of the therapeutic encounter can be quite different depending on the type of provider, the explanation or diagnosis given, the provider’s enthusiasm, and the patient’s expectations. Some researchers have suggested that relying on evidence from RCTs and systematic reviews of RCTs is not adequate to determine whether a treatment is effective or not. The main issue, they contend, is that the intervention when studied in RCTs is too highly protocolized and does not reflect what is going on in clinical practice. They advocate a whole systems research approach that more accurately represents the entire clinical encounter. When using this perspective and systematically synthesizing the literature regarding chiropractic treatment of non-musculoskeletal conditions, also reviewed in this report, they conclude, for example that chiropractic is beneficial to patients with asthma and to children with infantile colic. This conclusion is at odds with the evidence summaries found in this report. We submit that whole systems research approach in this instance is clouding the interpretation of the literature regarding effectiveness as it relates to making claims, and incorrectly giving the consumer the impression that chiropractic care shows effectiveness over and above the contextual effects as it relates to the two examples above.
In a placebo-controlled RCT the question is: does the treatment provided have a specific effect over and above the contextual or non-specific effects. The result of such a trial may show that there is no important difference between the active intervention and the sham intervention. However, the patients may exhibit clinically important changes from baseline in both groups and thus the outcome would be consistent with what clinicians observe in their practice. An example of this is the results of the pragmatic placebo controlled RCT on chiropractic co-management of chronic asthma in adults (care delivered by experienced chiropractors consistent with normal clinical practice), which showed that patients improved equally during both the active and the sham intervention phases of the trial.
The Pieces of The Evidence-Based Healthcare Puzzle
It is essential to recognize what each piece of the EBH puzzle offers. Patient values and preferences do not provide sound evidence of a treatment’s effectiveness and may be misleading. A patient can be satisfied with a treatment, but it still may not be effective. The clinician’s observations, if well documented, can attest to patient improvement while under care and encourage perception of a treatment’s clinical plausibility. However, the narrow focus of attention under non-systematic observations common to practice experience tends to obscure other factors influencing case outcome. Similarly, EBH can be flawed, not because it fails to be scientific, but because-like all sciences-it imports the biases of researchers and clinicians. Well-performed clinical research however, does provide evidence for claims that a treatment is effective when the results are consistently applied to relevant patients. This is because of its reliance on methods for systematic observation and efforts to minimize bias.
Other authors’ work has been used to argue that a range of study types should be included when evaluating a treatment’s efficacy/effectiveness (case series, etc.). We maintain the best evidence that rises to societal standards to support claims of efficacy/effectiveness comes from well-designed RCTs. This is largely due to the powerful effect of successful randomization and design factors intended to minimize bias (all which help ensure that the results are due to the intervention and not some other known or unknown factor). Other evidence may be useful to inform treatment options when conditions for individual patients are not consistent with the best evidence or when better evidence is unavailable. Other types of research are more appropriate for answering related questions including, but not limited to, safety or mechanistic plausibility. This can lead to the refinement of interventions, inform the design of clinical trials, and aid in the interpretation of clinical observations. Similarly, clinical data from epidemiological studies, case reports, and case series can suggest that a treatment is�clinically plausible. That is, clinical observations demonstrate that�it is possible�that an intervention is effective. However, a gain in plausibility, biological or clinical, does NOT constitute proof of a treatment’s efficacy in human populations. Conversely lack of proof (as demonstrated through well performed randomized clinical trials) does not exclude plausibility.
Research on systematic reviews have taught us that individual studies can often lead to a conclusion very different from that of a systematic analysis of all available studies. Moreover, the scientific process is a systematic means of self-correcting investigations that classically begin with observations and hypotheses that support plausibility and/or mechanisms. Ideally, these precede and inform the conduct of RCTs under conditions most likely to yield clear results, often referred to as efficacy studies. Separately, studies that emulate general practice conditions may be used to develop an understanding of effectiveness. Historically, the modern investigation of manual treatment methods represents an aberration in this process. With the advent of social support and funding for research at the end of the 20th�Century, there was an underlying presumption that the long-term practice of these methods provided a sound clinical wisdom on which to ground RCTs, bypassing mechanistic studies. The early emphasis on clinical trials has illuminated the gaps in understanding of appropriate indications for treatment, dosage and duration of care, consistency of treatment application, and the appropriate outcome measures to monitor results. In response, funding agencies in North America have renewed research emphasis on the potential mechanisms of effect. Data from this work is expected to inform future clinical research questions, and subsequently lead to well-grounded studies that are likely to yield more complete evidence regarding appropriate and effective care.
Safety of Manual Treatment
Choosing an intervention should always be tempered by the risk of adverse events or harm. Adverse events associated with manual treatment can be classified into two categories: 1) benign, minor or non-serious and 2) serious. Generally those that are benign are transient, mild to moderate in intensity, have little effect on activities, and are short lasting. Most commonly, these involve pain or discomfort to the musculoskeletal system. Less commonly, nausea, dizziness or tiredness are reported. Serious adverse events are disabling, require hospitalization and may be life-threatening. The most documented and discussed serious adverse event associated with spinal manipulation (specifically to the cervical spine) is vertebrobasilar artery (VBA) stroke. Less commonly reported are serious adverse events associated with lumbar spine manipulation, including lumbar disc herniation and cauda equina syndrome.
Estimates of serious adverse events as a result of spinal manipulation have been uncertain and varied. Much of the available evidence has been relatively poor due to challenges in establishing accurate risk estimates for rare events. Such estimates are best derived from sound population based studies, preferably those that are prospective in nature.
Estimates of VBA stroke subsequent to cervical spine manipulation range from one event in 200,000 treatments to one in several million. In a subsequent landmark population-based study, Cassidy et al revisited the issue using case-control and case-crossover designs to evaluate over 100 million person-years of data. The authors confirmed that VBA stroke is a very rare event in general. They stated, “We found no evidence of excess risk of VBA stroke associated with chiropractic care compared to primary care.” They further concluded, “The increased risk of VBA stroke associated with chiropractic and PCP (primary care physician) visits is likely due to patients with headache and neck pain from VBA dissection seeking care before their stroke.” In regards to benign adverse reactions, cervical spine manipulation has been shown to be associated with an increased risk when compared to mobilization.
Appropriately, the risk-benefit of cervical spine manipulation has been debated. As anticipated, new research can change what is known about the benefit of manual treatment for neck pain. Currently, the evidence suggests that it has some benefit. It has been suggested that the choice between mobilization and manipulation should be informed by patient preference.
Estimates of cervical or lumbar disc herniation are also uncertain, and are based on case studies and case series. It has been estimated that the risk of a serious adverse event, including lumbar disc herniation is approximately 1 per million patient visits. Cauda equina syndrome is estimated to occur much less frequently, at 1 per several million visits.
Safety of Manual Treatment in Children
The true incidence of serious adverse events in children as a result of spinal manipulation remains unknown. A systematic review published in 2007 identified 14 cases of direct adverse events involving neurologic or musculoskeletal events, nine of which were considered serious (eg. subarachnoid hemorrhage, paraplegia, etc.). Another 20 cases of indirect adverse events were identified (delayed diagnosis, inappropriate application of spinal manipulation for serious medical conditions). The review authors note that case reports and case series are a type of “passive” surveillance, and as such don’t provide information regarding incidence. Further, this type of reporting of adverse events is recognized to underestimate true risk.
Importantly, the authors postulate that a possible reason for incorrect diagnosis (for example. delayed diagnosis, inappropriate treatment with spinal manipulation) is due to lack of sufficient pediatric training. They cite their own survey�which found that in a survey of 287 chiropractors and osteopaths, 78% reported one semester or less of formal pediatric education and 72% received no pediatric clinical training. We find this particularly noteworthy.
Limitations of the Report Conclusions
The conclusions in this report regarding the strength of evidence of presence or absence of effectiveness are predicated on the rules chosen for which there are no absolute standards. Different evidence grading systems and rules regarding impact of study quality may lead to different conclusions. However, we have applied a synthesis methodology consistent with the latest recommendations from authoritative organizations involved in setting standards for evidence synthesis. Although we used a comprehensive literature search strategy we may not have identified all relevant RCTs, guidelines, and technology reports. Conditions for which this report concludes the evidence currently shows manual treatment to be effective or even ineffective, sometimes rests on a single RCT with adequate statistical power and low risk of bias. Additional high quality RCTs on the same topics have a substantial likelihood of changing the conclusions. Including only English language reviews and trials may be considered another limitation of this report leading to language bias; however, the impact of excluding non-English trials from meta-analyses and systematic reviews is conflicting, and the incidence of randomized trials published in non-English journals is declining. Another potential limitation of this report is the lack of critical appraisal of the systematic reviews and clinical guidelines included in the report. Systematic reviews and clinical guidelines can differ widely in methodologic quality and risk of bias. While critical appraisal of the included reviews and guidelines would be ideal, it was beyond the scope of the present report. When drawing conclusions about relative effectiveness of different forms of manual treatments it is acknowledged that it has usually not been possible to isolate or quantify the specific effects of the interventions from the non-specific (contextual) effect of patient-provider interaction. It was beyond the scope of this report to assess the magnitude of the effectiveness of the different manual therapies relative to the therapies to which comparisons were made. However, if moderate or high quality evidence of effectiveness was established the therapy was interpreted as a viable treatment option, but not necessarily the most effective treatment available. We recognize that findings from studies using a nonrandomized design (for example. observational studies, cohort studies, prospective clinical series and case reports) can yield important preliminary evidence on potential mechanisms and plausibility of treatment effects. However, the primary purpose of this report is to summarize the results of studies designed to specifically address treatment efficacy and effectiveness from which claims of clinical utility, consistent with that literature, may be considered defensible. Therefore, the evidence base on the effects of care was restricted to RCTs.
Conclusions
Spinal manipulation/mobilization is effective in adults for acute, subacute, and chronic low back pain; for migraine and cervicogenic headache; cervicogenic dizziness; and a number of upper and lower extremity joint conditions. Thoracic spinal manipulation/mobilization is effective for acute/subacute neck pain, and, when combined with exercise, cervical spinal/manipulation is effective for acute whiplash-associated disorders and for chronic neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for any type of manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1 hypertension when added to an antihypertensive diet. For children, the evidence is inconclusive regarding the effectiveness of spinal manipulation/mobilization for otitis media and enuresis, but shows it is not effective for infantile colic and for improving lung function in asthma when compared to sham manipulation.
The evidence regarding massage shows that for adults it is an effective treatment option for chronic LBP and chronic neck pain. The evidence is inconclusive for knee osteoarthritis, fibromyalgia, myofascial pain syndrome, migraine headache, and premenstrual syndrome. For children, the evidence is inconclusive for asthma and infantile colic.
Competing interests
All authors are trained as doctors of chiropractic but are now full time professional researchers.
Authors’ contributions
GB was responsible for the methodology used to select and summarize the evidence, for organizing and participating in the analysis of the evidence and formulating conclusions and drafting and finalizing the report.
MH participated in analyzing the evidence and formulating conclusions for the majority of the musculoskeletal conditions and the different types of headache.
RE participated in analyzing the evidence and formulating conclusion for part of the musculoskeletal and non-musculoskeletal conditions and providing substantial input to the background and discussion sections.
BL was responsible for retrieving the research articles and providing draft summary statements for all conditions as well as participating in drafting and proof reading the manuscript.
JT was responsible for conceiving and drafting the section on translation of research into action and providing substantial input to the background and discussion sections. All authors have read and approved the final manuscript.
Includes the criteria used for evaluating risk of bias from randomized controlled trials not included within systematic reviews, evidence based guidelines, or health technology assessments.
The UK General Chiropractic Council provided the funding for this scientific evidence report.
Della Shupe, librarian at NWHSU, is acknowledged for helping design and perform the detailed search strategy used for the report.
In conclusion, the results of the above research study determined that manual therapies, such as manipulation and/or mobilization are effective in adults for acute, subacute and chronic low back pain, migraine and cervicogenic headache, cervicogenic dizziness, as well as for several extremity joint conditions and acute/subacute neck pain. The clinical and experimental evidence was inconclusive alone for some cases of neck and back pain, sciatica, tension-type headache coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome and pneumonia in older adults.� Manual therapies, such as manipulation and/or mobilization were not effective for asthma and dysmenorrhea and well as for otitis media and enuresis or infantile colic and asthma.
Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
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Recognizing clinical and experimental evidence, physiotherapy is a healthcare profession that helps restore and maintain function to individuals affected by injury, disease or disability by using mechanical force and movements, manual therapy, exercise and electrotherapy, as well as through patient education and advice. The terms physiotherapy and physical therapy are used interchangeably to describe the same healthcare profession. Physiotherapy is recommended for a variety of injuries and conditions, and it can help support overall health and wellness for people of all ages.
For further notice,�physiotherapy services may be offered alongside chiropractic care, to provide a cautious and gentle manipulation and/or mobilization of the cervical and thoracic spine in the instance of a large cervical disc herniation. Cervical disc herniations can cause pain and discomfort, numbness and weakness in the neck, shoulders, chest, arms and hands.
Abstract
A 34-year-old woman was seen in a physiotherapy department with signs and symptoms of cervical radiculopathy. Loss of cervical lordosis and a large paracentral to intraforaminal disc prolapse (8?mm) at C5�C6 level was reported on MRI. She was taking diclofenac sodium, tramadol HCl, diazepam and pregabalin for the preceding 2?months and no significant improvement, except temporary relief, was reported. She was referred to physiotherapy while awaiting a surgical opinion from a neurosurgeon. In physiotherapy she was treated with mobilisation of the upper thoracic spine from C7 to T6 level. A cervical extension exercise was performed with prior voluntary extension of the thoracic spine and elevated shoulders. She was advised to continue the same at home. General posture advice was given. Signs and symptoms resolved within the following four sessions of treatment over 3?weeks. Surgical intervention was subsequently deemed unnecessary.
Background
Surgical interventions are commonly recommended in large cervical prolapsed discs and the importance of non-aggressive physiotherapy interventions is less recognised and poorly understood. We present interventions that were associated with resolution of symptoms of radiculopathy resulting from a larger cervical herniated disc. These interventions, if applied correctly, may help to reduce the number of surgeries required for cervical prolapsed discs.
Case Presentation
The patient was a 34-year-old woman. She was seen in the physiotherapy department with a complaint of left-sided neck and shoulder pain. The pain was radiating to her left arm and there was associated numbness. The duration of symptoms was more than 2?months with no history of trauma. The pain was present on waking in the morning and gradually increased during the day. She was otherwise a healthy woman. Neck movements were aggravating the symptoms. She was seen in the acute hospital accident and emergency department (A&E) twice since onset and had been taking diclofenac sodium, tramadol HCl, diazepam and pregabalin. An MRI was planned and a request was sent for physiotherapy during the MRI waiting period. A neurosurgical review was requested by the A&E consultant upon receipt of the MRI report 7?weeks later.
Patient examination in the physiotherapy department revealed a normal gait pattern, her left arm held in front of her chest with the left shoulder slightly elevated. Her active range of neck motion was restricted and was painful on the left side. Flexion and rotation to the left were aggravating her arm and shoulder pain. Strength deficits were noted in the left elbow flexors and wrist extensors (4/5) when compared with the right side. There was paraesthesia along the radial border of the forearm and thumb regions. The brachioradialis reflex was diminished and biceps reflex was sluggish. Triceps and plantar reflexes were normal. Passive intervertebral movements were tender at C5�C6 level and were reproducing the pain. Sustained pressure at C7 and below was easing the pain and also improving the neck range of motion. The patient was deemed to have C6 radiculopathy. The MRI report, available 2?weeks after the commencement of physiotherapy, confirmed the diagnosis.
Investigations
The findings from the plain cervical x-ray were unremarkable. MRI showed (Figure 1) loss of cervical spine lordosis, a left paracentral to intraforaminal lesion with 8?mm hernia, which indented the cord and obstructed the left paracentral recess and neural foramen.
Figure 1: Loss of cervical spine lordosis and large disc herniation at C5 and C6 on MRI.
Differential Diagnosis
Cervical myelopathy.
Treatment
The patient received pharmacological treatment for the initial two symptomatic months, which included diclofenic sodium, tramadol, diazepam and pregabalin (lyrica) tablet. Physiotherapy was started after 2?months. Physiotherapy intervention consisted of mobilisation of the thoracic spine, resisted cervical extension exercises, a home programme of exercises and advice regarding the posture.
Mobilisation of the thoracic spine was administered in the prone lying position from C7 toT6 level. Mild intensity oscillations (15?reps) in an anterosuperior direction were directly applied to each of the spinal segments, through the thumb over the spinous processes, during the first visit. The applied force was enough to appreciate intervertebral movement in each segment and without significant pain. High-intensity oscillations (10�20) were applied during the subsequent treatment sessions. The patient was asked for symptom feedback during treatment.
Cervical spine extension exercises were carried out in a sitting position. The patient was asked to extend her thoracic spine with lungs fully inflated and shoulders elevated followed by extension of her cervical spine. Head extension was moderately resisted by the therapist near the end range of extension for 5�10?s and brought back to neutral after each resisted movement. The resisted movement was repeated at least three times with intervals of 30?s. The patient was asked to perform the same exercise at home every hour during the day.
The patient was educated regarding the rationale of extension exercises, sitting and lying posture and their effects on the spine. The duration of each session was approximately 20�25?min.
Dr. Alex Jimenez’s Insight
Surgical interventions are generally recommended and widely considered for large cervical disc herniations. Although less recognized and often misunderstood, however, physiotherapy can be just as effective towards improving herniated discs in the cervical spine, excluding the need for surgery, according to the research study. Pharmacological treatments are also commonly used to help temporarily reduce symptoms alongside physiotherapy interventions. Cautious and gentle, spinal manipulation and mobilization of the cervical spine should be performed in the case of large cervical disc herniations to avoid aggravating the injury and/or condition. As recommended by a physiotherapist, or other healthcare professional experienced in physiotherapy, proper exercise can restore the function of the cervical spine and prevent regression of large prolapsed discs along the spine. Through appropriate physiotherapy intervention as well as through patient safety and compliance, the retraction of the cervical herniated discs is possible.
Outcome and Follow-Up
Pharmacological interventions were helpful to reduce the patient’s pain on a temporary basis. Symptoms were recurring and resolution was not sustainable. The symptoms started improving after the first physiotherapy session and continued to improve during the subsequent sessions. It fully resolved in four sessions extended over 3?weeks. The patient was reviewed 4?months after the resolution of symptoms and there was no recurrence of symptoms. She was reviewed by a neurosurgeon and the surgical option was withdrawn.
Discussion
Stiffness of the thoracic spine has been linked to the painful pathologies of the cervical spine, and manipulation of the thoracic spine has been shown to improve painful symptoms and mobility of the cervical spine. However, cervical disc herniations of greater than 4?mm are considered inappropriate for physiotherapy interventions such as traction and manipulation. Spinal manipulation refers to a passive movement thrust of high velocity and low amplitude, usually applied at the end range of movement and is beyond the patient’s control. Manipulation of the cervical spine is an aggressive procedure, which carries various risks and is often associated with worsening of symptoms. Manipulation was not considered in the treatment options for this patient because of the risks associated with it, and also because of patient’s anxiety and lack of MRI-confirmed diagnosis.
Active extension of the thoracic spine increases the range of motion of the cervical spine and, in these authors� clinical experience, relieves minor neck symptoms. Conversely, thoracic spine kyphosis, such as slouch sitting, restricts the mobility of the cervical spine and aggravates the painful symptoms. A good sitting posture is constituted by a slightly extended thoracic spine. Therefore, active extension of the thoracic spine prior to cervical extension may improve cervical movements and restore cervical curvature.
It is believed that excessive pressure during flexion on the anterior aspect of the intervertebral discs pushes the nucleus pulposus posteriorly and causes herniations. Conversely, cervical lordosis might have the reverse effect�that is, decreases pressure on the anterior aspect of the discs and may create a suction effect which retracts the herniated contents. Therefore, a combination of short duration and repeated movements at the end of extension may serve as a suction pump and possibly retract the extruded content of the disc. Active cervical extension exercises, with an extended thoracic spine posture, may have been the key element in a home exercise programme to restore lordosis of the cervical spine and relieve radiculopathy symptoms in the current case. This may possibly have been due to the retraction of the herniated discs.
Spinal mobilisation refers to a gentle, oscillatory, passive movement of a spinal segment. These are applied to a spinal segment to gently increase the passive range of motion. It allows the patient to report aggravation of pain and to resist any unwanted movements. No mobilisation treatment was administered at C5�C6 level as palpation at this level was aggravating the symptoms. Segments below this level were mobilised with emphasis at C7�T1 level. Any treatment at the affected segment was likely to irritate the nerve root and thereby increase the inflammatory process.
Various interventions are reported for the treatment of prolapsed discs. Saal et al reported the use of traction, specific physical therapy exercise, oral anti-inflammatory medication and patient education in the treatment of 26 patients with herniated cervical discs (<4?mm) and reported significant improvement in outcomes for 24 patients. They observed that surgery for disc herniations occurs when a patient has significant myotomal weakness, severe pain or pain that persists beyond an arbitrary conservative treatment period of 2�8?weeks.
Spontaneous regressions of cervical disc protrusions are reported in the literature. However, spontaneous regressions of herniated cervical discs are speculated to be rare. Various factors related to regression are hypothesised and theorised. Pan et al summarised the factors related to the resorption of herniated disc as: the age of the patients; dehydration of the expanded nucleus pulposus; resorption of haematoma; revascularisation; penetration of herniated cervical disc fragments through the posterior longitudinal ligament; size of disc herniations; and existence of cartilage and annulus fibrosus tissue in the herniated material. Some studies on spontaneous regressions of discs reported that the patients were receiving physiotherapy. Physiotherapy interventions are not defined in any of these studies, however. Therefore, it is possible that disc regressions in these studies may be due to similar physiotherapy interventions as described here, or the patients were practising techniques and adopting postures as reported in the current case.
Learning Points
Thoracic spine mobilisation improves cervical spine biomechanics and can be considered in conjunction with other interventions in all painful conditions of the cervical spine.
Active extension of the thoracic spine facilitates movements of the cervical spine and may help regression of large prolapsed discs.
There is a possibility of retraction of herniated cervical discs through appropriate physiotherapy intervention.
Patient education ensures safety and compliance to therapist advice.
Meticulous assessment and patient feedback guides the therapist in selection of intensity of mobilisation.
Footnotes
Competing interests: None.
Patient consent: Obtained.
In conclusion,�physiotherapy, or physical therapy, is used to treat various injuries, diseases and disabilities, through the use of mechanical force and movements, manual therapy, exercise, electrotherapy, and through patient education and advice to restore and maintain function. As in the case above, physiotherapy can be recommended and considered as treatment before referring to surgical interventions of large cervical disc herniations. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
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Cause Of Sciatica: Several lumbar spine (lower back) disorders can cause sciatica. Sciatica is often described as mild to intense pain in the left or right leg. Sciatica is caused by compression of one or more of the 5 sets of nerve roots in the lower back. Sometimes doctors call sciatica a radiculopathy. Radiculopathy is a medical term used to describe pain, numbness, tingling, and weakness in the arms or legs caused by a nerve root problem. If the nerve problem is in the neck, it is called a cervical radiculopathy. However, since sciatica affects the low back, it is called a lumbar radiculopathy.
Pathways To Sciatic Nerve Pain
Five sets of paired nerve roots in the lumbar spine combine to create the sciatic nerve. Starting at the back of the pelvis (sacrum), the sciatic nerve runs from the back, under the buttock, and downward through the hip area into each leg. Nerve roots are not “solitary” structures but are part of the body’s entire nervous system capable of transmitting pain and sensation to other parts of the body. Radiculopathy occurs when compression of a nerve root from a disc rupture (herniated disc) or bone spur (osteophyte) occurs in the lumbar spine prior to it joining the sciatic nerve.
What Causes Sciatic Nerve Compression?
Several spinal disorders can cause spinal nerve compression and sciatica or lumbar radiculopathy. The 6 most common are:
a bulging or herniated disc
lumbar spinal stenosis
spondylolisthesis
trauma
piriformis syndrome
spinal tumors
Sciatica�Cause:�6 Leading Sources
Several lumbar spine (lower back) disorders can cause sciatica. Sciatica is often described as mild to intense pain in the left or right leg. Sciatica is caused by compression of one or more of the 5 sets of nerve roots in the lower back. Sometimes doctors call sciatica a radiculopathy. Radiculopathy is a medical term used to describe pain, numbness, tingling, and weakness in the arms or legs caused by a nerve root problem. If the nerve problem is in the neck, it is called a cervical radiculopathy. However, since sciatica affects the low back, it is called a lumbar radiculopathy.
Sciatica Cause #1: Lumbar Bulging Disc Or Herniated Disc
A bulging disc is also known as a contained disc disorder. This means the gel-like center (nucleus pulposus) remains “contained” within the tire-like outer wall (annulus fibrosus) of the disc.
A herniated disc occurs when the nucleus breaks through the annulus fibrosus. It is called a “non-contained” disc disorder. Whether a disc bulges or herniates, disc material can press against an adjacent nerve root and compress delicate nerve tissue and cause sciatica.
The consequences of a herniated disc are worse. Not only does the herniated disc cause direct compression of the nerve root against the interior of the bony spinal canal, but the disc material itself also contains an acidic, chemical irritant (hyaluronic acid) that causes nerve inflammation. In both cases, nerve compression and irritation cause inflammation and pain, often leading to extremity numbness, tingling, and muscle weakness.
Herniated disc is a relatively common condition that can occur anywhere along the spine, but most often affects the lower back or neck region. Also known as a slipped disc or ruptured disc, a herniated disc develops when one of the cushion-like pads between the vertebrae moves out of position and presses on adjacent nerves.
Herniated discs are typically caused by overuse injuries or trauma to the spine; however, disc conditions can also develop as a result of the normal aging process. It is also known that there is a genetic factor that contributes to the development of disc degeneration and herniated disc. In most cases, a herniated disc in the lower back will heal within six months, as the size of herniation shrinks with time via resorption. Surgery may be needed if medication, physical therapy and other treatments fail.
What Is A Disc?
Spinal discs are cushion-like pads located between the vertebrae. Without these �shock absorbers,� the bones in the spine would grind against one another. In addition to giving the spine flexibility and making movements such as twisting and bending possible, discs protect the spine by absorbing the impact of trauma and body weight. Each disc has a strong outer layer called annulus fibrosus and a soft, gel-like center, called nucleus pulposus. There are fibers on the outside of each disc that attach to adjacent vertebrae and hold the disc in place. A herniated disc occurs when the outer layer tears or ruptures and the gel-like center leaks into the spinal canal.
The spinal canal has just enough space to house the spinal cord and spinal fluid. When a disc herniates and spills into the spinal canal, it can cause compression of the nerves or spinal cord. Intense, debilitating pain and alterations in sensation often occur. In addition, the gel-like substance inside the disc releases chemical irritants that contribute to nerve inflammation and pain.
What Causes A Herniated Disc?
As we age, the spinal discs gradually lose fluid volume. This process starts at about age 30 and progresses slowly, over time. As the discs dry out, microscopic cracks or tears can form on the outer surface, causing it to become brittle, weak and more susceptible to injury. The most common causes of herniated disc are:
Wear and tear: Discs dry out and aren�t as flexible as they once were.
Repetitive movements: Work, lifestyle, and certain sports activities that put stress on the spine, especially the lower back, further weaken an already vulnerable area.
Lifting the wrong way: Never lift while bent at the waist. Proper lifting entails lifting with your legs and a straight back.
Injury: High-impact trauma can cause the disc to bulge, tear or rupture.
Obesity: Carrying excess weight puts an undue amount of strain on the spine.
Genetics: There are some genes that are more commonly present in individuals with disc degeneration. More research is needed to investigate the role of these genes�they could be targets of biological treatment in the future.
What Are The Symptoms Of A Herniated Disc?
Pain from a herniated disc can vary, depending on the location and severity of the injury. It is typically felt on one side of the body.
If the injury is minimal, little or no pain may be felt. If the disc ruptures, pain can be severe and unrelenting. Pain may radiate to an extremity in a specific nerve root distribution if significant nerve impingement has occurred. For example, sciatica is frequently caused by a herniated disc in the lower back. Herniated disc can manifest itself with a range of symptoms, including:
Dull ache to severe pain
Numbness, tingling, burning
Muscle weakness; spasm; altered reflexes
Loss of bowel or bladder control (Note: These symptoms constitute a medical emergency. If they occur, seek medical attention immediately).
How Is A Herniated Disc Diagnosed?
History and physical examination point to a diagnosis of herniated disc. A herniated disc is likely if low back pain is accompanied by radiating leg pain in a nerve root distribution with positive straight leg raising test (ie, elevating the leg while lying down causes radiating pain down the leg), and other neurologic deficits such as numbness, weakness, and altered reflexes.
Imaging studies are usually ordered to confirm a diagnosis of herniated disc. X-rays are not the imaging medium of choice because soft tissues (eg, discs, nerves) are hard to capture with this technology. However, they may be used as an initial tool to rule out other disorders such as a growth or fracture. Confirmation of the suspicion of herniated disc is generally accomplished with:
Magnetic Resonance Imaging (MRI): This technology reveals the spinal cord, surrounding soft tissue and nerves. It is the best imaging study to support the diagnosis of a herniated disc.
Nerve Conduction Studies (NCS) and Electromyogram (EMG): These studies use electrical impulses to measure the degree of damage to the nerve/s caused by compression from a herniated disc and other conditions that cause nerve impingement can be ruled out. NCS and EMG are not routine tests to diagnose herniated disc.
Herniated discs sometimes heal on their own through a process called resorption. This means that the disc fragments are absorbed by the body. Most people suffering from herniated disc respond well to conservative treatment and do not require surgery.
Sciatica Cause #2: Lumbar Spinal Stenosis
Spinal stenosis is a nerve compression disorder most often affecting older adults. Leg pain similar to sciatica may occur as a result of lumbar spinal stenosis. The pain is usually positional, often brought on by activities such as standing or walking and relieved by sitting down.
Spinal nerve roots branch outward from the spinal cord through passageways called neural foramina comprised of bone and ligaments. Between each set of vertebral bodies, located on the left and right sides, is a foramen. Nerve roots pass through these openings and extend outward beyond the spinal column to innervate other parts of the body. When these passageways become narrow or clogged causing nerve compression, the term foraminal stenosis is used.
What Is Spinal Stenosis?
A clue to answering this question is found in the meaning of each word. Spinal refers to the spine. Stenosis is a medical term used to describe a condition where a normal-size opening has become narrow. Spinal stenosis may affect the cervical (neck), thoracic (chest), or lumbar (lower back) spines.
The most commonly area affected is the lumbar spine followed by the cervical spine.
Visualize Spinal Stenosis?
Consider a water pipe. Over time, rust and debris builds up on the walls of the pipe, thereby narrowing the passageway that normally allows water to freely flow. In the spine, the passageways are the spinal canal and the neuroforamen. The spinal canal is a hollow vertical hole that contains the spinal cord. The neuroforamen are the passageways that are naturally created between the vertebrae through which spinal nerve roots exit the spinal canal.
The neuroforamen are the passageways that are naturally created between the vertebrae through which spinal nerve roots exit the spinal canal.
Illustration above: The spine’s bony structures encase and protect the spinal cord. Small nerve roots shoot off from the spinal cord and exit the spinal canal through passageways called neuroforamen.
Lumbar (low back) spinal stenosis is illustrated below. Notice the narrowed areas in the spinal canal (reddish-colored areas). As the canal space narrows, the spinal cord and nearby nerve roots are squeezed causing different types of symptoms. The medical term is nerve compression.
Anatomy Overview Can Help You Understand Spinal Stenosis
The spine is a column of connected bones called vertebrae. There are 24 vertebrae in the spine, plus the sacrum and tailbone (coccyx). Most adults have 7 vertebrae in the neck (the cervical vertebrae), 12 from the shoulders to the waist (the thoracic vertebrae), and 5 in the lower back (the lumbar vertebrae). The sacrum is made up of 5 vertebrae between the hipbones that are fused into one bone. The coccyx is made up of small fused bones at the tail end of the spine.
Lamina and Spinous Processes: At the back (posterior) of each vertebra, you have the lamina, a bony plate that protects your spinal canal and spinal cord. Your vertebrae also have several bony tabs that are called spinous processes; those processes are attachment points for muscles and ligaments.
Ligaments, Especially the Ligamentum Flavum: Vertebrae are connected by ligaments, which keep the vertebrae in their proper place. The ligamentum flavum is a particularly important ligament. Not only does it help stabilize your spine, it also protects your spinal cord and nerve roots. Plus, the ligamentum flavum is the strongest ligament in your spine.
The ligamentum flavum is a dynamic structure, which means that it adapts its shape as you move your body. When you’re sitting down and leaning forward, the ligamentum flavum is stretched out; that gives your spinal canal more room for the spinal nerves. When you stand up and lean back, though, the ligamentum flavum becomes shorter and thicker; that means there’s less room for the spinal nerves. (This dynamic capability helps explain why people with spinal stenosis find that sitting down feels better than standing or walking.)
Discs: In between each vertebra are tough fibrous shock-absorbing pads called the intervertebral discs. Each disc is made up of a tire-like outer band (annulus fibrosus) and a gel-like inner substance (nucleus pulposus).
Spinal Nerves and the Spinal Cord: Nerves are also an important part of your spinal anatomy�after all, they’re what sends messages from your brain to the rest of your body. The spinal cord, the thick bundle of nerves that extends downward from the brain, passes through a ring in each vertebra. Those rings line up into a channel called the spinal canal.
Between each vertebra, two nerves branch out of the spinal cord (one to the right and one to the left). Those nerves exit the spine through openings called the foramen and travel to all parts of your body.
Normally, the spinal channel is wide enough for the spinal cord, and the foramen are wide enough for the nerve roots. But either or both can become narrowed, and cause spinal stenosis.
Sciatica Cause #3: Spondylolisthesis
Spondylolisthesis is a disorder that most often affects the lumbar spine. It is characterized by one vertebra slipping forward over an adjacent vertebra. When a vertebra slips and is displaced, spinal nerve root compression occurs and often causes sciatic leg pain. Spondylolisthesis is categorized as developmental (found at birth, develops during childhood) or acquired from spinal degeneration, trauma or physical stress (eg, lifting weights).
Spondylolisthesis occurs when one vertebra slips forward over the vertebra below it. The term is pronounced spondy-low-lis-thesis and is derived from the Greek language: spondylo means vertebra and listhesis means to slip. There are several types or causes of spondylolisthesis; a few are listed below.
Congenital spondylolisthesis means the disorder is present at birth.
Isthmic spondylolisthesis occurs when a defect, such as a fracture occurs in a bony supporting vertebral structure at the back of the spine.
Degenerative spondylolisthesis is more common and is often associated with degenerative disc disease, wherein the discs (eg, due to the effects of growing older) lose hydration and resilency.
How Spondylolisthesis May Develop
The lumbar spine is exposed to directional pressures while it carries, absorbs, and distributes most of your body’s weight at rest and during activity. In other words, while your lumbar spine is carrying and absorbing body weight, it also moves in different directions (eg, rotate, bend forward). Sometimes, this combination causes excessive stress to the vertebra and/or its supporting structures, and may lead to a vertebral body slipping forward over the vertebrae beneath.
Who May Be At Risk
If a family member (eg, mother, father) has spondylolisthesis, your risk for developing the disorder may be greater. Some activities make you more susceptible to spondylolisthesis. Gymnasts, linemen in football, and weight lifters all put significant pressure and weight on their low backs. Think about gymnasts and the positions they put their body in: They practically bend in half backwards�that’s an extreme arched back. They also twist through the air quickly when doing flips and then land, absorbing the impact through their legs and low back. Those movements put substantial stress on the spine, and spondylolisthesis can develop as a result of repeated excessive strains and stress.
X-Ray View Of Spondylolisthesis
The x-ray below shows you a good example of a lumbar spondylolisthesis. Look at the area the arrow is pointing to: You can see that the vertebra above the arrow isn’t in line with the vertebra below it. It’s slipped forward; it’s spondylolisthesis.
Arrow Points To A Lumbar Spondylolisthesis
Grading Spondylolisthesis
Doctors “grade” the severity of a spondylolisthesis using five descriptive categories. Although there are several factors your doctor considers when evaluating your spondylolisthesis, the grading scale (below) is based on the far forward a vertebral body has slid forward over the vertera beneath. Often, the doctor uses a lateral (side view) x-ray to examine and grade a spondyloisthesis. Grade I is a smaller slip than Grade IV or V.
Grade I: Less than 25% slip
Grade II: 25% to 49% slip.
Grade III: 50% to 74% slip.
Grade IV: 75% to 99% slip.
Grade V: The vertebra that has fallen forward off the vertebra below it. This is the most severe type of spondylolisthesis and is termed spondyloptosis.
Sciatica Cause #4: Trauma
Sciatica can result from direct nerve compression caused by external forces to the lumbar or sacral spinal nerve roots. Examples include motor vehicle accidents, falling down, football and other sports. The impact may injure the nerves or, occasionally, fragments of broken bone may compress the nerves.
Sciatica Cause #5: Piriformis Syndrome
Piriformis syndrome is named for the piriformis muscle and the pain caused when the muscle irritates the sciatic nerve. The piriformis muscle is located in the lower part of the spine, connects to the thighbone, and assists in hip rotation. The sciatic nerve runs beneath the piriformis muscle. Piriformis syndrome develops when muscle spasms develop in the piriformis muscle thereby compressing the sciatic nerve. It may be difficult to diagnose and treat due to the lack of x-ray or magnetic resonance imaging (MRI) findings.
If you�ve ever felt pain in the hip, pain in the center of the butt, or pain down the back of the leg, you are likely suffering, at least partially, with piriformis syndrome. The piriformis is a muscle which runs from your sacrum (mid-line base of spine) to the outer hip bone (trochanter). This muscle truly works overtime on anyone who runs at all.
The muscles in and around the gluteal region help with three areas
rotation of the hip and leg;
balance while one foot is off the ground; and
stability for the pelvic region.
Needless to say, all of these characteristics are highly needed by runners (and everyone else, when you come to think of it).
Injuries To The Piriformis
This muscle is a prime candidate for repetitive motion injury (RMI). RMI occurs when a muscle is asked to perform beyond it�s level of capability, not given enough time to recover, and asked to perform again. The typical response from a muscle in this situation is to tighten, which is a defensive response of the muscle. This tightness, however, manifests itself in several ways to a runner.
The first symptom suggesting piriformis syndrome would be pain in and around the outer hip bone. The tightness of the muscle produces increased tension between the tendon and the bone which produces either direct discomfort and pain or an increased tension in the joint producing a bursitis. Again, a bursitis is an inflammation of the fluid filled sac in a joint caused by an elevation of stress and tension within that joint.
The second symptom suggesting piriformis syndrome would be pain directly in the center of the buttocks. Although this is not as common as the other two symtpoms, this pain can be elicited with direct compression over the belly of the buttocks area. A tight muscle is a sore muscle upon compression due to a reduced blood flow to that muscle.
The third symptom suggesting piriformis syndrome would be a sciatic neuralgia, or pain from the buttocks down the back of the leg and sometimes into different portions of the lower leg. We have an article that can teach you more about how piriformis syndrome and sciatica are related.
The sciatic nerve runs right through the belly of the piriformis muscle and if the piriformis muscle contracts from being overused, the sciatic nerve now becomes strangled, producing pain, tingling and numbness.
Simple Physiology
Any muscle repetitively used needs to have an opportunity to recover. This recovery can either be on Nature�s clock, or can be facilitated and sped up with proper knowledge and treatment. Since the muscle is tightening due to overuse, continued use will only make it worse. This injured muscle needs to relax and have increased blood flow encouraged to it for more rapid healing. This tightness that exists also reduces the normal blood flow going to the muscle reducing the speed with which the muscle can recover. To encourage fresh, oxygen-rich blood to the muscle is the most powerful means of getting the muscle to begin to relax and function normally. Multiple massages per day to this area is greatly encouraged.
The next step in this “recovery” process is to use a tennis ball under the butt and hip area. While sitting down on the floor, roll away from the side of involvement and place a tennis ball just inside the outer hip bone under the butt area. As you begin to allow your weight onto the tennis ball, note areas of increased pain and soreness. Trigger points will tend to accumulate in a repetitively used muscle, and until these toxins are manually broken up and eliminated, the muscle will have an artificial ceiling with regard to flexibility potential and recovery potential. So, if it�s sore and hurts while your sitting on it, you�re doing a good job. Let the ball work under each spot for 15-20 seconds before moving it to another area. Once you�ve been on the ball for 4-5 minutes, now put the ankle of the involved leg over the knee of the non-involved leg (crossing your legs). Now place the tennis ball just inside the outer hip bone again and work the tendon of the piriformis muscle. While this pain is typically excruciating and takes some time to effectively reduce, the benefits here are huge. Be patient, be consistent and good things will happen.
Additional Treatments
Due to the fact that the sciatic neuralgia and the hip bursitis or tendonitis are both inflammatory in nature, ice, or cryotherapy, over the involved area 15-20 minutes at a time will be beneficial. This should be done multiple times per day.
Stretching of the hip muscles should not be done until the acute pain is gone. At that point in time, begin with gentle stretching, such as the cross-legged stretch while pulling up on the knee. The muscle should have increased flexibility before an active return to running.
Finally, I�m always discouraging the use of pharmaceutical anti-inflammatories. Not only do they greatly aggravate the intestines, but they also suggest an artificial wellness that can lead to bigger problems. Proteolytic enzymes, such as bromelain, are both natural and extremely beneficial with no side effects.
Conclusion: The piriformis muscle is pretty important for all of us.
Sciatica Cause #6: Spinal Tumors
Spinal tumors are abnormal growths that are either benign or cancerous (malignant). Fortunately, spinal tumors are rare. However, when a spinal tumor develops in the lumbar region, there is a risk for sciatica to develop as a result of nerve compression.
If you think you have sciatica, call your doctor or chiropractor. The first step toward relieving pain is a proper diagnosis.
Written by Jean-Jacques Abitbol, MD; Reviewed by Brian R. Subach, MD
Howard S. An, MD, Stewart G. Eidelson, MD; Reviewed by Howard S. An, MD, Jason M. Highsmith, MD
Timothy J. Maggs, D.C.; Reviewed by Edward C. Benzel, MD
Understanding the following, traditional Chinese medicine utilizes herbal medicines as well as various mind and body practices, such as acupuncture and tai chi, in order to treat or prevent numerous health issues. Traditional Chinese medicine, or TCM, originated in ancient China and has evolved over thousands of years. TCM has been primarily used as a complementary health approach along with other alternative treatment options like chiropractic care. Like TCM, chiropractic care is an alternative healthcare approach focused on the diagnosis, treatment and prevention of a variety of injuries and conditions of the musculoskeletal and nervous system, with an emphasis on manual manipulations and adjustments of the spine. As a doctor of chiropractic, or DC, TCM can also be offered to treat various types of injuries and conditions.
On a personal note, integrative TCM conservative therapies have been utilized to help treat symptoms of low back pain due to lumbar disc herniation, or LDH. Disc material from a ruptured or herniated disc in the lumbar spine can irritate or compress one or several of the nerves found in the lower spine. Pressure along the sciatic nerve can cause symptoms of sciatica, such as pain and discomfort, burning and tingling sensations, and numbness which may radiate from the buttocks into the leg and occasionally, down to the foot.�A randomized controlled trial was conducted in order to measure the outcomes of traditional Chinese medicine for low back pain due to LDH. The results have been recorded below.
Abstract
Low back pain due to lumbar disc herniation (LDH) is very common in clinic. This randomized controlled trial was designed to investigate the effects of integrative TCM conservative therapy for low back pain due to LDH. A total of 408 patients with low back pain due to LDH were randomly assigned to an experimental group with integrative TCM therapy and a control group with normal conservative treatment by the ratio of 3?:?1. The primary outcome was the pain by the visual analogue scale (VAS). The secondary outcome was the low back functional activities by Chinese Short Form Oswestry Disability Index (C-SFODI). Immediately after treatment, patients in the experimental group experienced significant improvements in VAS and C-SFODI compared with the control group (between-group difference in mean change from baseline, ?16.62 points, P < 0.001 in VAS; ?15.55 points, P < 0.001 in C-SFODI). The difference remained at one-month followup, but it is only significant in C-SFODI at six-month followup (?7.68 points, P < 0.001). No serious adverse events were observed. These findings suggest that integrative TCM therapy may be a beneficial complementary and alternative therapy for patients with low back pain due to LDH.
Introduction
Lumbar disc herniation (LDH) is a common disease and a major contributing factor of low back pain. Although many studies have confirmed that surgery is more effective for LDH, conservative therapies have also been recognized for their therapeutic efficacy. Considering the fact that 20% of patients still have pain after surgery, 7% to 15% of surgical patients may have failed back surgery syndrome, and some patients are scared of surgery, conservative treatment is still one of the primary means for LDH.
In China, TCM is one of the main conservative treatments for LDH. Previous studies have confirmed that some TCM therapies have certain effects on low back pain due to LDH. These include acupuncture, oral administration of Chinese medicine, external application of Chinese medicine, Chinese Tuina (massage), and TCM-characteristic functional exercise. Clinically, these therapeutic methods are not used alone but often in combination. Recently, the clinical pathway of treating LDH with integrative TCM therapy has attracted attention. The Shi’s Traumatology Medical Center of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine is well recognized for its long-term commitment to the research on conservative treatment for LDH, coupled with a package protocol for LDH. However, high-quality research evidence is needed to support the effectiveness of the protocol.
This clinical trial aims to study the efficacy and safety of integrative TCM therapy for LDH and thus confirm its clinical effect.
Materials and Methods
Design
We conducted a multicenter, randomized controlled trial to evaluate the effectiveness of integrative TCM conservative treatment for patients with low back pain due to LDH. Patients were randomly assigned to an experimental group and a control group by the ratio of 3?:?1 using computer-generated numbers. The randomized treatment assignments were sealed in opaque envelopes and opened individually for each patient who agreed to be in the study. The nurse, who had no role in the design and conduct of the study, prepared the envelopes. Patients in the experimental group were treated with integrative TCM therapy once a day, for two weeks, whereas patients in the control group were treated with a two-week normal conservative intervention. At baseline, immediately after treatment, one and six months after treatment, visual analogue scale (VAS) and the Chinese Short Form Oswestry Disability Index (C-SFODI) were used as outcome assessment. This trial is registered in Chinese Clinical Trial Registry (No. ChiCTR-TRC-11001343).
Subjects
Patients were recruited from Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Ruijin Hospital Affiliated to Shanghai Jiaotong University, and Yueyang Integrative Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine between January 2011 and August 2012.
Inclusion criteria: (1) aging 20�60 years; (2) having low back pain due to LDH (MRI scan confirmed lumbar disk herniation) and ruling out other relevant ongoing pathologies such as fractures, lumbar spondylolisthesis, tumor, osteoporosis, or infection; (3) willing to participate in this study and signing the informed consent.
Exclusion criteria: (1) having other pain syndromes; (2) experiencing a history of spinal surgery; (3) having neurological disease; (4) having psychiatric disease; (5) having serious chronic diseases that could interfere with the outcomes (e.g., cardiovascular disease, rheumatoid arthritis, epilepsy, or other disqualifying conditions); (6) scared of acupuncture; (7) pregnant or planning to become pregnant during the study; (8) having other diseases that the researchers believe is not suitable for the study.
Treatment
Experimental Group
Patients in the experimental group receive a two-week integrative TCM treatment. They were further divided into three subgroups (according to the duration from initial low back pain to getting treatment) for different treatment methods: acute stage (0�14 days), subacute stage (15�30 days), and chronic stage (>30 days).
Acute stage: (1) Electroacupuncture + (2) Chinese herbal injection (Salvia miltiorrhiza injection) + (3) external plaster (Compound Redbud Injury-healing Cataplasms); Subacute stag: (1) Chinese Tuina (massage) + (2) hot compress using Chinese medicine + (3) external plaster (Compound Redbud Injury-healing Cataplasms); Chronic stage: (1) TCM functional exercise + (2) external plaster (Compound Redbud Injury-healing Cataplasms).
Treatment Parameters
Electroacupuncture. Points: bilateral Dachangshu (BL 25) and Baihuanshu (BL 30).
Method: Insert the needles (the sterile, disposable needles, 0.3 � 75?mm, manufactured by Suzhou Medical Supplies Factory Co., Ltd.) 2.5 to 2.8?cun. Upon De Qi (needling sensation), connect the needles with the electroacupuncture device (Model: G6805-II, manufactured by Guangzhou KangMai Medical Devices Co., Ltd.), using a continuous wave, an electrical stimulation pulse wave of approximately 0.6?ms and a frequency of 20?Hz. The treatment was conducted once every day, 30?min for each treatment.
Main ingredients: Zi Jing Pi (Cortex Cercis Chinensis), Huang Jing Zi (Negundo Chastetree Fruit), Da Huang (Radix et Rhizoma Rhei), Chuan Xiong (Rhizoma Chuanxiong), Tian Nan Xing (Rhizoma Arisaematis), and Ma Qian Zi (Semen Strychni).
Functions: Circulates blood, resolves stasis, eliminates swelling, and alleviates pain.
Method: Apply the cataplasms to the most painful area, one plaster each time, once a day.
Chinese Herbal Injection. Salvia miltiorrhiza injection (Approval no. Z51021303, manufactured by Sichuan ShengHe Pharmaceutical Co., Ltd.).
The main ingredient of the injection is Salvia root P.E. It acts to circulate blood and resolve stasis.
Method: Intravenous dripping of 20?mL salvia miltiorrhiza injection and 250 mL 5% glucose, once a day.
Hot Compress Using Chinese Medicine. Ingredients: 20?g of Cang Zhu (Rhizoma Atractylodis), Qin Jiao (Radix Gentianae Macrophyllae), Sang Zhi (Ramulus Mori), Mu Gua (Fructus Chaenomelis), Hong Hua (Flos Carthami), Chuan Xiong (Rhizoma Chuanxiong), Hai Feng Teng (Caulis Piperis Kadsurae) and Lei Gong Teng (Radix Tripterygii Wilfordii), respectively. All herbs were provided by Shanghai Hongqiao Pharmaceutical Co., Ltd. and have been tested and qualified.
Method: Place the previous medicinal into a gauze bag, decoct with water for 20?mins and take it out. After the temperature cooled to 40~45�C, apply the back to the affected low back area for 30�40 minutes, once a day. The hot compress can help circulate blood and resolve stasis.
TCM Functional Exercise. The exercise is known as �Fei Yan Shi� (literally meaning �the flying swallow style�) in Chinese.
Method: Ask the patient to take a prone position, extend both hands backwards, lift the chest and lower limbs off the bed using the abdomen as a pivot, and then relax. Conduct this exercise once a day and repeat 4-5 times each time.
Functions: Strengthens the power of back muscles, increases the stability of the spine, and thus prevents relapses.
Chinese Tuina (Massage). Ask the patient to take a prone position and find the tenderness spots on the low back. Then apply gun-rolling (10?min), Anrou-pressing and kneading (10?min), and Tanbo-plucking (5?min) manipulation to the tenderness spots and surrounding areas. Conclude with oblique pulling manipulation of the low back. Conduct the treatment once a day.
Functions: Relaxes spasm of the low back muscles and adjusts lumbar subluxation.
After one week TCM treatment, if the patient’s lower back pain without any relief or even aggravated, the prescription of pain medication was adjusted according to clinical guidelines, detailed records the type and dose of pain medication taken by patients, and the patient was identified as no effect.
Control Group
Patients in the control group receive a two-week normal conservative treatment. Intervention measures include three sections, (1) health education. The patients were invited to receive LDH health education twice a week in outpatient; the health education was designed exclusively to inform patients about the natural course of their illness and the expectation of successful recovery, irrespective of the initial intensity of their pain, educate patients to avoid some bad habits that aggravate the disease, such as a sitting position for a long time and carrying heavy loads, and encourage patients to participate in social activities. (2) Rest: in addition to the normal sleep, the patients need to rest in bed for at least 1-2 hours a day. (3) Pain medication or physical therapy: after one week health education, if the patient’s lower back pain without any relief or even aggravated, the prescription of pain medication was adjusted according to clinical guidelines, detailed records the type and dose of pain medication taken by patients. And if the patients do not want to take pain medication, then the patients were referred to a physiotherapist.
Measurements
All outcomes were assessed by observers unaware of the grouping, at baseline (M1), immediately after the last intervention (M2). The followup included the assessments at one month (M3) and six months (M4) after the last intervention.
The primary outcome measure was the change in pain by the visual analogue scale (VAS), scores range 0 to 100, and a higher score indicates a greater pain, 0 means no pain, and 100 means intolerable pain.
The secondary outcome measure was the change in the Chinese Short Form Oswestry Disability Index (C-SFODI), range 0 to 100%. The C-SFODI consists of nine questions, which come from Oswestry Disability Index (ODI); omit the sex life question in Section??8, because this question is always unacceptable by Chinese. The C-SFODI calculation formula is actual cumulative score/45 � 100%, with higher percentage indicating more severe functional disability. And the study has shown that the C-SFODI has good reliability and validity.
Statistical Analysis
Our pretrial power calculation indicated that 81 patients in experimental group were required to detect a difference in pain relief based on the preliminary experiment data at a significant level of 5% (a two-sided t-test) with 80% power. In anticipation of a 20% attrition rate, we sought 102 patients at least in experimental group. Taking into account the poor effect of control therapy, 102 patients were included in the control group.
Between-group difference at baseline was analyzed using independent-samples t-test or Chi-square test. Changes in continuous measures were analyzed by analysis of variance (ANOVA). Effects were evaluated on an intention-to-treat basis (ITT), and participants who did not complete the followup period were considered not having any changes in scores. A two-sided P value of less than 0.05 indicated statistical significance. Results are presented as mean and standard deviation (SD) at M1 and as between-group difference with 95% confidence intervals (CI) at M2, M3, and M4.
Quality Control
Before the beginning of the study, all researchers have to receive protocol training. A clinic research coordinator (CRC) was employed to assist researchers in each center. A monitor was also appointed to ensure the quality of the research.
Dr. Alex Jimenez’s Insight
The above clinical trial focused on investigating the safety and effectiveness of TCM, or traditional Chinese medicine, for low back pain due to lumbar disc herniation as well as to confirm its clinical result. The participants of the research study with low back pain due to LDH were divided into two groups: the experimental group, which was treated with integrative TCM conservative therapy; and the control group, which was treated normal conservative treatment. The experimental group was then further divided into three subgroups. The details of each TCM treatment method used in the subgroups, including the name, ingredients, method and function of each, are described above. The outcomes were measured accordingly by observers unaware of the specific group divisions. The statistic results were properly analyzed by researchers who received protocol training before the start of the study.
Results
Between January 2011 and August 2012, a total of 480 patients with low back pain due to LDH were recruited, 72 were rejected due to exclusion criterions, and 408 eligible patients were randomly assigned in accordance with the ratio of 3?:?1 to the experimental group and the control group, 306 in the experimental group and 102 in the control group. Patients in the experimental group all completed a two-week treatment. In the control group, at the second week one patient in the control group was unwilling to continue to participate and withdrew his informed consent, and two patients took Fenbid (500?mg for each dose, 2 doses a day) since the pain worsened during treatment (Figure 1).
Figure 1: Screening, randomization, and completion evaluations from the baseline to six-month followup, LDH = lumbar disc herniation.
Baseline Characteristics of the Patients
Table 1 shows the baseline data for the 408 participants. The mean age of all patients is 45 years, and 51% were women. In terms of disease staging, experimental group and control group were comparable. And the baseline outcome including VAS scores and C-SFODI were also reasonably well balanced between experimental group and control group.
Table 1: Baseline characteristics of the study participants.
Improvement in the Primary Outcome
The changes in the primary outcomes from baseline to six-month followup are shown in Table 2 and Figure 2. Immediately after the intervention, two groups showed significant decrease in VAS than the baseline. And the experimental group showed a more significant decrease than the control group (?16.62 points [95% confidence interval {CI}, ?20.25 to ?12.98]; P < 0.001).
Figure 2: Mean changes of the primary and secondary outcomes. The means of outcomes are shown for the experimental group (diamond) and the control group (squares). Measurements were obtained at baseline (M1), immediately after the last intervention (M2).
Table 2: Changes in primary and secondary outcomes.
One month after intervention, two groups also had significantly greater reduction in VAS than the baseline. And again, the experimental group showed a more significant decrease than the control group (?6.37 points [95% CI, ?10.20 to ?2.54]; P = 0.001).
Six months after intervention, compared with the baseline, the changes in VAS remained significant in the experimental group and control group, but between-group difference was not significant (P = 0.091).
Improvement in the Secondary Outcome
Immediately after intervention, two groups had significant improvement in C-SFODI than the baseline, and the experimental group showed a more significant improvement than the control group (?15.55 points [95% CI, ?18.92 to ?12.18]; P < 0.001).
One month after intervention, two groups also had significant improvement in C-SFODI than the baseline. And again, the experimental group improved more (?11.37 points [95% CI, ?14.62 to ?8.11]; P < 0.001).
Six months after intervention, two groups also maintained significant improvement, and the experimental group showed superiority (?7.68 points [95% CI, ?11.42 to ?3.94]; P < 0.001).
Adverse Events
One patient in the experiment group had mild fainting during acupuncture, remission by bed rest, and then completed the remaining treatment. Two patients in the control group were given Fenbid orally due to aggravated low back pain. No other adverse events were noted in either experimental group or control group.
Discussion
Although the mechanism of low back pain caused by lumbar disc herniation (LDH) is still not very clear, the prevailing view is that low back pain due to LDH was found to occur not only in response to mechanical stimuli but also to chemical irritation around the nerve root sheath and sinuvertebral nerve.
Different TCM therapies have different advantages in the treatment of LDH. Pain is the main symptom in the acute stage of LDH; acupuncture has good analgesic effect on low back pain due to LDH. Lumbar dysfunction is the main symptom in the remission stage; Chinese massage has good effect on improving dysfunction. Oral Chinese herbal formulae, external use of Chinese medicine, and Chinese herbal injection also showed good effect in relieving pain and improving dysfunction caused by LDH. And one study also found that Salvia miltiorrhiza injection especially works better and faster for the acute stage when compared with mannitol. Although the mechanism of acupuncture, Chinese massage, and traditional Chinese herbs in the treatment of LDH remains unclear, it is generally agreed that these treatment methods play a role by increasing local blood circulation, relieving nerve root edema, and speeding up the metabolism of the local inflammatory mediators. In recovery stage of the disease, the major task is to strengthen the muscles of the waist and abdomen to prevent relapse, and TCM functional exercise has advantages in this regard and can subsequently increase the lumbar stability to prevent recurrence.
Treating LDH according to different stages has been more and more accepted. In China, LDH is mainly divided into three stages, including acute stage, subacute stage (or remission stage), and chronic stage (or recovery stage). Studies have proven that treating LDH according to different stages has obtained a good clinical effect. In addition, studies have also suggested that it can obtain a better effect than treatment without differentiating different stages.
The past 20 years of clinical practice have witnessed the safety of the treatment regimens used in this study. At the same time, its efficacy has been preliminarily confirmed; however, high quality research evidence is still needed. In the treatment regimens, different TCM therapies were selected according to the characteristics of different stages. Specifically, acupuncture and Chinese herbal injections were used in the acute stage for fast pain relief, Chinese Tuina (massage) and external application of Chinese medicine were used in the subacute stage for improvement of the lumbar functions, and low back muscle exercise was used in the chronic stage to increase the stability of the spine and prevent relapses.
In China, nonsurgical treatment of lumbar disc herniation mainly uses drugs, physical therapy, or TCM treatment. TCM treatment used in the experimental group has been used in clinical routine and is considered to have good clinical efficacy; the efficacy of conservative treatment used in the control group is considered very weak, usually as auxiliary treatment of other therapies. Ethics Committee considers that in order to maximize the protection of the interests of the patients, it is necessary to let the patients have more opportunity to receive TCM treatment, so in this research the sample size of the experimental group and the control group is 3?:?1.
The findings of this study have shown that immediately and one month after intervention, integrative TCM conservative treatment can significantly reduce the VAS scores and C-SFODI, and at six month after intervention, integrative TCM conservative treatment can also significantly reduce the C-SFODI, but two groups have no significant difference in reducing VAS score. VAS is an international general pain visual analog scale, and C-SFODI is the improved version of the ODI (Oswestry Disability Index), and it consists of 9 questions, a higher percentage indicating a more severe functional disability.
Regarding adverse events, one patient had mild fainting in the experiment group, two patients in the control group were given Fenbid oral due to low back pain aggravation, and no other adverse events were noted in either experimental group or control group. The mechanism of integrative TCM conservative treatment for LDH remains unclear, and it will be our future research orientation.
The main limitation of this study is the short followup time. As a result, we failed to conduct comprehensive evaluation regarding the long-term efficacy of integrative TCM conservative treatment for LDH.
Conclusions
This randomized controlled clinical trial provides reliable evidence regarding the effectiveness of integrative TCM conservative treatment for patients with low back pain due to lumbar disc herniation. A large sample of long-term followup is further needed for future research.
Conflict of Interests
No potential conflict of interests relevant to this study was reported.
Acknowledgments
This work is supported by the Key Discipline of TCM Orthopaedic and Traumatic of the Ministry of Education of the People’s Republic of China (100508); the Medical Key Project of Shanghai Science and Technology Commission (09411953400); the project of Shanghai Medical leading talent (041); the National Natural Science Foundation of China (81073114, 81001528); the National Key New Drugs Creation Project, innovative drug research and development technology platform (no. 2012ZX09303009-001); Shanghai University Innovation Team Construction Project of the Spine Disease of Traditional Chinese Medicine (2009-26).
In conclusion, with the measured outcomes and final results of the two groups of participants with low back pain due to lumbar disc herniation, the randomized controlled trial helped contribute valuable information regarding the safety and effectiveness, as well as the clinical effect of integrative TCM conservative therapy. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
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