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Chiropractic Spinal Manipulative Therapy for Migraine

Chiropractic Spinal Manipulative Therapy for Migraine

Headaches can be a real aggravating issue, especially if these begin to occur more frequently. Even more so, headaches can become a bigger problem when the common type of head pain becomes a migraine. Head pain is often a symptom resulting from an underlying injury and/or condition along the cervical spine, or upper back and neck. Fortunately, a variety of treatment methods are available to help treat headaches. Chiropractic care is a well-known alternative treatment option which is commonly recommended for neck pain, headaches and migraines. The purpose of the following research study is to determine the effectiveness of chiropractic spinal manipulative therapy for migraine.

Chiropractic Spinal Manipulative Therapy for Migraine: a Study Protocol of a Single-Blinded Placebo-Controlled Randomised Clinical Trial

 

Abstract

 

Introduction

 

Migraine affects 15% of the population, and has substantial health and socioeconomic costs. Pharmacological management is first-line treatment. However, acute and/or prophylactic medicine might not be tolerated due to side effects or contraindications. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs in a single-blinded placebo-controlled randomised clinical trial (RCT).

 

Method and Analysis

 

According to the power calculations, 90 participants are needed in the RCT. Participants will be randomised into one of three groups: CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1?month run-in, 3?months intervention and follow-up analyses at the end of the intervention and 3, 6 and 12?months. The primary end point is migraine frequency, while migraine duration, migraine intensity, headache index (frequency x duration x intensity) and medicine consumption are secondary end points. Primary analysis will assess a change in migraine frequency from baseline to the end of the intervention and follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Owing to two group comparisons, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a p value below 0.05 will be used. The results will be presented with the corresponding p values and 95% CIs.

 

Ethics and Dissemination

 

The RCT will follow the clinical trial guidelines from the International Headache Society. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services have approved the project. Procedure will be conducted according to the declaration of Helsinki. The results will be published at scientific meetings and in peer-reviewed journals.

 

Trial Registration Number

 

NCT01741714.

Keywords: Statistics & Research Methods

 

Strengths and Limitations of this Study

 

  • The study will be the first three-armed manual therapy randomised clinical trial (RCT) assessing the efficacy of chiropractic spinal manipulative therapy versus placebo (sham manipulation) and control (continue usual pharmacological management without receiving manual intervention) for migraineurs.
  • Strong internal validity, since a single chiropractor will conduct all interventions.
  • The RCT has the potential to provide a non-pharmacological treatment option for migraineurs.
  • Risk for dropouts is increased due to strict exclusion criteria and 17?months duration of the RCT.
  • A generally accepted placebo has not been established for manual therapy; thus, there is a risk for unsuccessful blinding, while the investigator who provides the interventions cannot be blinded for obvious reasons.

 

Background

 

Migraine is a common health problem with substantial health and socioeconomic costs. On the recent Global Burden of Disease study, migraine was ranked as the third most common condition.[1]

 

Image of a woman with a migraine demonstrated by lightning coming out of her head.

 

About 15% of the general population have migraine.[2, 3] Migraine is usually unilateral with pulsating and moderate/severe headache which is aggravated by routine physical activity, and is accompanied by photophobia and phonophobia, nausea and sometimes vomiting.[4] Migraine exists in two major forms, migraine without aura and migraine with aura (below). Aura is reversible neurological disturbances of the vision, sensory and/or speech function, occurring prior to the headache. However, intraindividual variations from attack to attack are common.[5, 6] The origin of migraine is debated. The painful impulses may originate from the trigeminal nerve, central and/or peripheral mechanisms.[7, 8] Extracranial pain sensitive structures include the skin, muscles, arteries, periosteum and joints. The skin is sensitive to all usual forms of pain stimuli, while temporal and neck muscles may especially be sources for pain and tenderness in migraine.[9�11] Similarly, the frontal supraorbital, superficial temporal, posterior and occipital arteries are sensitive to pain.[9, 12]

 

Notes

 

The International Classification of Headache Disorders-II Diagnostic Criteria for Migraine

 

Migraine without Aura

  • A. At least five attacks fulfilling criteria B�D
  • B. Headache attacks lasting 4�72?h (untreated or unsuccessfully treated)
  • C. Headache has at least two of the following characteristics:
  • 1. Unilateral location
  • 2. Pulsating quality
  • 3. Moderate or severe pain intensity
  • 4. Aggravated by or causing avoidance of routine physical activity
  • D. During headache at least one of the following:
  • 1. Nausea and/or vomiting
  • 2. Photophobia and phonophobia
  • E. Not attributed to another disorder
  • Migraine with aura
  • A. At least two attacks fulfilling criteria B�D
  • B. Aura consisting of at least one of the following, but no motor weakness:
  • 1. Fully reversible visual symptoms including positive features (ie, flickering lights, spots or lines) and/or negative features (ie, loss of vision). Moderate or severe pain intensity
  • 2. Fully reversible sensory symptoms including positive features (ie, pins and needles) and/or negative features (ie, numbness)
  • 3. Fully reversible dysphasic speech disturbance
  • C. At least two of the following:
  • 1. Homonymous visual symptoms and/or unilateral sensory symptoms
  • 2. At least one aura symptom develops gradually over ?5?min and/or different aura symptoms occur in succession over ?5?min
  • 3. Each symptom lasts ?5 and ?60?min
  • D. Headache fulfilling criteria B-D for 1.1 Migraine without aura begins during the aura or follows the aura within 60?min
  • E. Not attributed to another disorder

 

Pharmacological management is the first treatment option for migraineurs. However, some patients do not tolerate acute and/or prophylactic medicine due to side effects or contraindications due to comorbidity of other diseases or due to a wish to avoid medication for other reasons. The risk of medication overuse due to frequent migraine attacks represents a major health hazard with direct and indirect cost concerns. The prevalence of medication overuse headache (MOH) is 1�2% in the general population,[13�15] that is, about half the population suffering chronic headache (15 headache days or more per month) have MOH.[16] Migraine causes loss of 270 workdays per year per 1000 persons from the general population.[17] This corresponds to about 3700 work years lost per year in Norway due to migraine. The economic cost per migraineur was estimated to be $655 in USA and �579 in Europe per year.[18, 19] Owing to the high prevalence of migraine, the total cost per year was estimated to be $14.4 billion in the USA and �27 billion in the EU countries, Iceland, Norway and Switzerland at that time. Migraine costs more than neurological disorders such as dementia, multiple sclerosis, Parkinson’s disease and stroke.[20] Thus, non-pharmacological treatment options are warranted.

 

The Diversified technique and the Gonstead method are the two most commonly used chiropractic manipulative treatment modalities in the profession, used by 91% and 59%, respectively,[21, 22] along with other manual and non-manual interventions, that is, soft tissue techniques, spinal and peripheral mobilisation, rehabilitation, postural corrections and exercises as well as general nutrition and dietetic advice.

 

A few spinal manipulative therapy (SMT) randomised controlled trials (RCTs) using the Diversified technique have been conducted for migraine, suggesting an effect on migraine frequency, migraine duration, migraine intensity and medicine consumption.[23�26] However, common for previous RCTs are the methodological shortcomings such as inaccurate headache diagnosis, that is, questionnaire diagnoses used are imprecise,[27] inadequate or no randomisation procedure, lack of placebo group, and primary and secondary end points not prespecified.[28�31] In addition, previous RCTs did not consequently adhere to the recommended clinical guidelines from the International Headache Society (IHS).[32, 33] At present, no RCTs have applied the Gonstead chiropractic SMT (CSMT) method. Thus, considering the methodological shortcomings in previous RCTs, a clinical placebo-controlled RCT with improved methodological quality remains to be conducted for migraine.

 

The SMT mechanism of action on migraine is unknown. It is argued that migraine might originate from a complexity of nociceptive afferent responses involving the upper cervical spine (C1, C2 and C3), leading to a hypersensitivity state of the trigeminal pathway conveying sensory information for the face and much of the head.[34, 35] Research has thus suggested that SMT may stimulate neural inhibitory systems at different spinal cord levels, and might activate various central descending inhibitory pathways.[36�40] However, although the proposed physiological mechanisms are not fully understood, there are most likely additional unexplored mechanisms which could explain the effect SMT has on mechanical pain sensitisation.

 

Double image of a woman with a migraine and a diagram showcasing the human brain during a migraine.

 

The objective of this study is to assess the efficacy of CSMT versus placebo (sham manipulation) and controls (continue usual pharmacological management without receiving manual intervention) for migraineurs in an RCT.

 

Method and Design

 

This is a single-blinded placebo-controlled RCT with three parallel groups (CSMT, placebo and control). Our primary hypothesis is that CSMT gives at least 25% reduction in the average number of migraine days per month (30?days/month) as compared to placebo and control from baseline to the end of intervention, and we expect the same reduction to be maintained at 3, 6 and 12?months follow-up. If the CSMT treatment is effective, it will be offered to participants who received placebo or control after study completion, that is, after 12?months follow-up. The study will adhere to the recommended clinical trial guidelines from the IHS,32 33 and the methodological CONSORT and SPIRIT guidelines.[41, 42]

 

Patient Population

 

Participants will be recruited in the period January to September 2013 through the Akershus University Hospital, through general practitioners and media advertisement, that is, posters with general information will be put up at general practitioners� offices along with oral information in the Akershus and Oslo counties, Norway. Participants will receive posted information about the project followed by a short telephone interview. Those recruited from the general practitioners� offices will have to contact the clinical investigator whose contact details have been provided on the posters in order to obtain extensive information about the study.

 

Eligible participants are between 18 and 70?years of age and have at least one migraine attack per month. Participants are diagnosed according to the diagnostic criteria of the International Classification of Headache Disorders (ICHD-II) by a neurologist at the Akershus University Hospital.[43] They are only allowed to have co-occurrence of tension-type headache and not other primary headaches.

 

Exclusion criteria are contraindication to SMT, spinal radiculopathy, pregnancy, depression and CSMT within the previous 12?months. Participants whom during the RCT receive any manual interventions by physiotherapists, chiropractors, osteopaths or other health professionals to treat musculoskeletal pain and disability, including massage therapy, joint mobilisation and manipulation,[44] changed their prophylactic headache medicine or pregnancy will be withdrawn from the study at that time and be regarded as dropouts. They are allowed to continue and change their usual acute migraine medication throughout the trial.

 

In response to initial contact, participants fulfilling the inclusion criteria will be invited to further assessment by the chiropractic investigator. The assessment includes an interview and a physical examination with special emphasis on the whole spinal column. Oral and written information about the project will be provided in advance and oral and written consent will be obtained from all accepted participants during the interview and by the clinical investigator. In accordance with good clinical practice, all patients will be informed about the harms and benefits as well as possible adverse reactions of the intervention primarily including local tenderness and tiredness on the treatment day. No serious adverse events have been reported for the chiropractic Gonstead method.[45, 46] Participants randomised into active or placebo interventions will undergo a full spine radiographic examination and be scheduled for 12 intervention sessions. The control group will not be exposed to this assessment.

 

Clinical RCT

 

The clinical RCT consists of a 1?month run-in and 3?months intervention. Time profile will be assessed from baseline to the end of follow-up for all end points (Figure 1).

 

Figure 1 Study Flow Chart

Figure 1: Study flow chart. CSMT, chiropractic spinal manipulative therapy; Placebo, sham manipulation; Control, continue usual pharmacological management without receiving manual intervention.

 

Run-In

 

The participants will fill in a validated diagnostic paper headache diary 1?month prior to intervention which will be used as baseline data for all participants.[47, 48] The validated diary includes questions directly related to the primary and secondary end points. X-rays will be taken in standing position in the anterioposterior and lateral planes of the entire spine. The X-rays will be assessed by the chiropractic investigator.

 

Randomisation

 

Prepared sealed lots with the three interventions, that is, active treatment, placebo and the control group, will be subdivided into four subgroups by age and gender, that is, 18�39 and 40�70?years of age and men and women, respectively. Participants will be equally allocated to the three groups by allowing the participant to draw one lot only. The block randomisation will be administrated by an external trained party with no involvement from the clinical investigator.

 

Intervention

 

Active treatment consists of CSMT using the Gonstead method,[21] that is, a specific contact, high-velocity, low-amplitude, short-lever spinal with no postadjustment recoil directed to spinal biomechanical dysfunction (full spine approach) as diagnosed by standard chiropractic tests.

 

The placebo intervention consists of sham manipulation, that is, a broad non-specific contact, low-velocity, low-amplitude sham push manoeuvre in a non-intentional and non-therapeutic directional line. All the non-therapeutic contacts will be performed outside the spinal column with adequate joint slack and without soft tissue pretension so that no joint cavitations occur. In some sessions, the participant lay either prone on a Zenith 2010 HYLO bench with the investigator standing at the participant’s right side with his left palm placed on the participant’s right lateral scapular edge with the other hand reinforcing. In other sessions, the investigator will stand at the participant’s left side and place his right palm over the participant’s left scapular edge with the left hand reinforcing, delivering a non-intentional lateral push manoeuvre. Alternatively, the participant lay in the same side posture position as the active treatment group with the bottom leg straight and the top leg flexed with the top leg’s ankle resting on the bottom leg’s knee fold, in preparation for a side posture push move, which will be delivered as a non-intentional push in the gluteal region. The sham manipulation alternatives will be equally interchanged among the placebo participants according to protocol during the 12-week treatment period to strengthen the study validity. The active and the placebo groups will receive the same structural and motion assessment prior to and after each intervention. No additional cointerventions or advice will be given to participants during the trial period. The treatment period will include 12 consultations, that is, twice per week in the first 3?weeks followed by once a week in the next 2?weeks and once every second week until 12?weeks are reached. Fifteen minutes will be allocated per consultation for each participant. All interventions will be conducted at the Akershus University Hospital and administered by an experienced chiropractor (AC).

 

Image of an older man receiving chiropractic care for migraine relief.

 

Dr Jimenez works on wrestler's neck_preview

 

The control group will continue usual care, that is, pharmacological management without receiving manual intervention by the clinical investigator. The same exclusion criteria apply for the control group during the whole study period.

 

Blinding

 

After each treatment session, the participants who receive active or placebo intervention will complete a de-blinding questionnaire administrated by an external trained independent party with no involvement from the clinical investigator, that is, providing a dichotomous �yes� or �no� answer as to whether active treatment was received. This response was followed by a second question regarding how certain they were that active treatment was received on a 0�10 numeric rating scale (NRS), where 0 represents absolutely uncertain and 10 represents absolutely certainty. The control group and the clinical investigator can for obvious reasons not be blinded.[49, 50]

 

Follow-Up

 

Follow-up analysis will be conducted on the end points measured after the end of intervention and at 3, 6 and 12?months follow-up. During this period, all participants will continue to fill in a diagnostic paper headache diary and return it on a monthly basis. In the case of unreturned diary or missing values in the diary, the participants will be contacted immediately on detection to minimise recall bias. Participants will be contacted by phone to secure compliance.

 

Primary and Secondary End Points

 

The primary and secondary end points are listed below. The end points adhere to the recommended IHS clinical trial guidelines.[32, 33] We define number of migraine days as the primary end point and expect at least a 25% reduction in average number of days from baseline to the end of intervention, with the same level of reduction being maintained at follow-up. On the basis of previous reviews on migraine, a 25% reduction is considered to be a conservative estimate.[30] A 25% reduction is also expected in secondary end points from baseline to the end of intervention, retaining at follow-up for migraine duration, migraine intensity and headache index, where the index is calculated as number of migraine days (30?days)�average migraine duration (hours per day)�average intensity (0�10 NRS). A 50% reduction in medication consumption from baseline to the end of intervention and to follow-up is expected.

 

Notes

 

Primary and Secondary End Points

 

Primary End Points

  • 1. Number of migraine days in active treatment versus placebo group.
  • 2. Number of migraine days in active treatment versus control group.

Secondary End Points

  • 3. Migraine duration in hours in active treatment versus placebo group.
  • 4. Migraine duration in hours in active treatment versus control group.
  • 5. Self-reported VAS in active treatment versus placebo group.
  • 6. Self-reported VAS in active treatment versus control group.
  • 7. Headache index (frequency x duration x intensity) in active treatment versus placebo group.
  • 8. Headache index in active treatment versus control group.
  • 9. Headache medication dosage in active treatment versus placebo group.
  • 10. Headache medication dosage in active treatment versus control group.

 

*The data analysis is based on the run-in period versus end of intervention. Point 11�40 will be duplicate of point 1�10 above at 3, 6 and 12?months follow-up, respectively.

 

Data Processing

 

A flow chart of the participants is shown in Figure 2. Baseline demographic and clinical characteristics will be tabulated as means and SDs for continuous variables and proportions and percentages for categorical variables. Each of three groups will be described separately. Primary and secondary end points will be presented by suitable descriptive statistics in each group and for each time point. Normality of end points will be assessed graphically and transformation will be considered if necessary.

 

Figure 2 Expected Participant's Flow Diagram

Figure 2: Expected participant’s flow diagram. CSMT, chiropractic spinal manipulative therapy; Placebo, sham manipulation; Control, continue usual pharmacological management without receiving manual intervention.

 

Change in primary and secondary end points from baseline to the end of intervention and to follow-up will be compared between the active and placebo groups and the active and control groups. The null hypothesis states that there is no significant difference between the groups in average change, while the alternative hypothesis states that a difference of at least 25% exists.

 

Owing to the follow-up period, repeated recordings of primary and secondary end points will be available, and analyses of trend in primary and secondary end points will be of main interest. Intra-individual correlations (cluster effect) are likely to be present in data with repeated measurements. Cluster effect will thus be assessed by calculating intraclass correlation coefficient quantifying the proportion of total variation attributable to the intraindividual variations. The trend in end points will be assessed by a linear regression model for longitudinal data (linear mixed model) to correctly account for the possible cluster effect. The linear mixed model handles unbalanced data, enabling all available information from randomised patients to be included, as well as from dropouts. Regression models with fixed effects for time component and group allocation as well as the interaction between the two will be estimated. The interaction will quantify possible differences between groups regarding time trend in the end points and serve as an omnibus test. Random effects for patients will be included to adjust the estimates for intraindividual correlations. Random slopes will be considered. The linear mixed models will be estimated by the SAS PROC MIXED procedure. The two pairwise comparisons will be performed by deriving individual time point contrasts within each group with the corresponding p values and 95% CIs.

 

Both per-protocol and intention-to-treat analyses will be conducted if relevant. All analyses will be performed by a statistician, blinded for group allocation and participants. All adverse effects will also be registered and presented. Participants who experience any sort of adverse effects during the trial period will be entitled to call the clinical investigator on the project cell phone. The data will be analysed with SPSS V.22 and SAS V.9.3. Owing to two group comparisons in the primary end point, p values below 0.025 will be considered statistically significant. For all secondary end points and analyses, a significance level of 0.05 will be used. Missing values might appear in incomplete interview questionnaires, incomplete headache diaries, missed intervention sessions and/or due to dropouts. The pattern of missingness will be assessed and missing values handled adequately.

 

Power Calculation

 

Sample size calculations are based on the results in a recently published group comparison study on topiramate.[51] We hypothesise that the average difference in reduction of number of days with migraine per month between the active and the placebo groups is 2.5?days. The same difference is assumed between the active and control groups. SD for reduction in each group is assumed to be equal to 2.5. Under the assumption of, on average, 10 migraine days per month at baseline in each group and no change in the placebo or control group during the study, 2.5?days reduction corresponds to a reduction by 25%. Since primary analysis includes two group comparisons, we set a significance level at 0.025. A sample size of 20 patients is required in each group to detect a statistically significant average difference in reduction of 25% with 80% power. To allow for dropouts, the investigators plan to recruit 120 participants.

 

Dr Jimenez White Coat

Dr. Alex Jimenez’s Insight

“I’ve been recommended to seek chiropractic care for my migraine-type headaches. Is chiropractic spinal manipulative therapy effective for migraine?”�Many different types of treatment options can be utilized to effectively treat migraine, however, chiropractic care is one of the most popular treatment approaches for naturally treating migraine. Chiropractic spinal manipulative therapy�is the traditional high-velocity low-amplitude (HVLA) thrust. Also known as spinal manipulation, a chiropractor performs this chiropractic technique by applying a controlled sudden force to a joint while the body is positioned in a specific way. According to the following article, chiropractic spinal manipulative therapy can effectively help treat migraine.

 

Discussion

 

Methodological Considerations

 

Current SMT RCTs on migraine suggest treatment efficacy regarding migraine frequency, duration and intensity. However, a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings.[30] Such studies should adhere to the recommended IHS clinical trial guidelines with migraine frequency as the primary end point and migraine duration, migraine intensity, headache index and medication consumption as secondary end points.[32, 33] The headache index, as well as a combination of frequency, duration and intensity, gives an indication of the total level of suffering. Despite the lack of consensus, the headache index has been recommended as an accepted standard secondary end point.[33, 52, 53] The primary and secondary end points will be collected prospectively in a validated diagnostic headache diary for all participants in order to minimise recall bias.[47, 48] To the best of our knowledge, this is the first prospective manual therapy in a three-armed single-blinded placebo-controlled RCT to be conducted for migraine. The study design adheres to the recommendations for pharmacological RCTs as far as possible. RCTs that include a placebo group and a control group are advantageous to pragmatic RCTs that compare two active treatment arms. RCTs also provide the best approach for producing safety as well as efficacy data.

 

Image of a woman with a migraine holding her head.

 

Unsuccessful blinding is a possible risk to the RCT. Blinding is often difficult as there is no single validated standardised chiropractic sham intervention which can be used as a control group for this date. It is, however, necessary to include a placebo group in order to produce a true net effect of the active intervention. Consensus about an appropriate placebo for a clinical trial of SMT among experts representing clinicians and academics has, however, not been reached.[54] No previous studies have, to the best of our knowledge, validated a successful blinding of a CSMT clinical trial with multiple treatment sessions. We intend to minimise this risk by following the proposed protocol for the placebo group.

 

The placebo response is furthermore high in pharmacological and assumed similarly high for non-pharmacological clinical studies; however, it might even be higher in manual therapy RCTs were attention and physical contact is involved.[55] Similarly, a natural concern with regard to attention bias will be involved for the control group as it is not being seen by anyone or not seen as much by the clinical investigator as the other two groups.

 

There are always risks for dropouts due to various reasons. Since the trial duration is 17?months with a 12?month follow-up period, the risk for loss to follow-up is thus enhanced. Co-occurrence of other manual intervention during the trial period is another possible risk, as those who receive manipulation or other manual physical treatments elsewhere during the trial period will be withdrawn from the study and regarded as dropouts at the time of violation.

 

The external validity of the RCT might be a weakness as there is only one investigator. However, we found that advantageous to multiple investigators, in order to provide similar information to participants in all three groups and manual intervention in the CSMT and the placebo groups. Thus, we intend to eliminate inter-investigator variability which might be present if there are two or more investigators. Although the Gonstead method is the second most commonly used technique among chiropractors, we do not see an issue of concern when it comes to generalisability and external validity. Furthermore, the block randomisation procedure will provide a homogeneous sample across the three groups.

 

The internal validity is, however, strong by having one treating clinician. It reduces the risk of potential selection, information and experimental biases. Furthermore, the diagnosis of all participants is performed by experienced neurologists and not by questionnaires. A direct interview has higher sensitivity and specificity as compared to a questionnaire.[27] Individual motivational factors which can influence a participant’s perception and personal preferences when treating are both reduced by having one investigator. In addition, the internal validity is further strengthened by a concealed validated randomisation procedure. Since age and genders may play a role in migraine, block randomisation was found necessary to balance arms by age and gender in order to reduce possible age-related and/or gender-related bias.

 

Image of X-rays demonstrating loss of cervical lordosis as a possible cause for migraine.

X-rays demonstrating loss of cervical lordosis as a possible cause for migraine.

 

Conducting X-rays prior to the active and placebo interventions was found to be applicable in order to visualise posture, joint and disc integrity.[56, 57] Since the total X-ray radiation dose varies from 0.2�0.8?mSv, the radiation exposure was considered low.[58, 59] X-ray assessments were also found to be necessary in order to determine if full spine X-rays are useful in future studies or not.

 

Since we are unaware of the mechanisms of possible efficacy, and both spinal cord and central descending inhibitory pathways have been postulated, we see no reasons to exclude a full spine treatment approach for the intervention group. It has furthermore been postulated that pain in different spinal regions should not be regarded as separate disorders but rather as a single entity.[60] Similarly, including a full spine approach limits the differentiations between the CSMT and the placebo groups. Thus, it might strengthen the likelihood of successful blinding in the placebo group being achieved. In addition, all the placebo contacts will be performed outside the spinal column, thus minimising a possible spinal cord afferent input.

 

Innovative and Scientific Value

 

This RCT will highlight and validate the Gonstead CSMT for migraineurs, which has not previously been studied. If CSMT proves to be effective, it will provide a non-pharmacological treatment option. This is especially important as some migraineurs do not have efficacy of prescript acute and/or prophylactic medications, while others have non-tolerable side effects or comorbidity of other diseases that contradict medication while others wish to avoid medication for various reasons. Thus, if CSMT works, it can really have an impact on migraine treatment. The study also bridges cooperation between chiropractors and physicians, which is important in order to make healthcare more efficient. Finally, our method might be applied in future chiropractic and other manual therapy RCTs on headache.

 

Ethics and Dissemination

 

Ethics

 

The study has been approved by the Norwegian Regional Committee for Medical Research Ethics (REK) (2010/1639/REK) and the Norwegian Social Science Data Services (11�77). The declaration of Helsinki is otherwise followed. All data will be anonymised while participants must give oral and written informed consent. Insurance is provided through �The Norwegian System of Compensation to Patients� (NPE), which is an independent national body set up to process compensation claims from patients who have suffered an injury as a result of treatment under the Norwegian health service. A stopping rule was defined for withdrawing participants from this study in accordance with recommendations in the CONSORT extension for Better Reporting of Harms.[61] If a participant reports to their chiropractor or research staff a severe adverse event, he or she will be withdrawn from the study and referred to their general practitioner or hospital emergency department depending on the nature of the event. The final data set will be available to the clinical investigator (AC), the independent and blinded statistician (JSB) and Study Director (MBR). Data will be stored in a locked cabinet at the Research Centre, Akershus University Hospital, Norway, for 5?years.

 

Dissemination

 

This project is due for completion 3?years after the start. Results will be published in peer-reviewed international scientific journals in accordance with the CONSORT 2010 Statement. Positive, negative, as well as inconclusive results will be published. In addition, a written lay summary of the results will be available to study participants on request. All authors should qualify for authorship according to the International Committee of Medical Journal Editors, 1997. Each author should have participated sufficiently in the work to take public responsibility for the content. The final decision on the order of authorship will be decided when the project has been finalised. The results from the study may, moreover, be presented as posters or oral presentations at national and/or international conferences.

 

Acknowledgments

 

Akershus University Hospital kindly provided research facilities. Chiropractor Clinic1, Oslo, Norway, performed X-ray assessments.

 

Footnotes

 

Contributors: AC and PJT had the original idea for the study. AC and MBR obtained funding. MBR planned the overall design. AC prepared the initial draft and PJT commented on the final version of the research protocol. JSB performed all the statistical analyses. AC, JSB, PJT and MBR were involved in the interpretation and assisted in the revision and preparation of the manuscript. All authors have read and approved the final manuscript.

 

Funding: The study has received funding from Extrastiftelsen (grant number: 2829002), the Norwegian Chiropractic Association (grant number: 2829001), Akershus University Hospital (grant number: N/A) and University of Oslo in Norway (grant number: N/A).

 

Competing interests: None declared.

 

Patient consent: Obtained.

 

Ethics approval: The Norwegian Regional Committee for Medical Research Ethics approved the project (ID of the approval: 2010/1639/REK).

 

Provenance and peer review: Not commissioned; externally peer reviewed.

 

A Randomized Controlled Trial of Chiropractic Spinal Manipulative Therapy for Migraine

 

Abstract

 

Objective: To assess the efficacy of chiropractic spinal manipulative therapy (SMT) in the treatment of migraine.

 

Design: A randomized controlled trial of 6 months’ duration. The trial consisted of 3 stages: 2 months of data collection (before treatment), 2 months of treatment, and a further 2 months of data collection (after treatment). Comparison of outcomes to the initial baseline factors was made at the end of the 6 months for both an SMT group and a control group.

 

Setting: Chiropractic Research Center of Macquarie University.

 

Participants: One hundred twenty-seven volunteers between the ages of 10 and 70 years were recruited through media advertising. The diagnosis of migraine was made on the basis of the International Headache Society standard, with a minimum of at least one migraine per month.

 

Interventions: Two months of chiropractic SMT (diversified technique) at vertebral fixations determined by the practitioner (maximum of 16 treatments).

 

Main Outcome Measures: Participants completed standard headache diaries during the entire trial noting the frequency, intensity (visual analogue score), duration, disability, associated symptoms, and use of medication for each migraine episode.

 

Results: The average response of the treatment group (n = 83) showed statistically significant improvement in migraine frequency (P < .005), duration (P < .01), disability (P < .05), and medication use (P< .001) when compared with the control group (n = 40). Four persons failed to complete the trial because of a variety of causes, including change in residence, a motor vehicle accident, and increased migraine frequency. Expressed in other terms, 22% of participants reported more than a 90% reduction of migraines as a consequence of the 2 months of SMT. Approximately 50% more participants reported significant improvement in the morbidity of each episode.

 

Conclusion: The results of this study support previous results showing that some people report significant improvement in migraines after chiropractic SMT. A high percentage (>80%) of participants reported stress as a major factor for their migraines. It appears probable that chiropractic care has an effect on the physical conditions related to stress and that in these people the effects of the migraine are reduced.

 

In conclusion, chiropractic spinal manipulative therapy can be used effectively to help treat migraine, according to the research study. Furthermore, chiropractic care improved the individual’s overall health and wellness. The well-being of the human body as a whole is believed to be one of the biggest factors as to why chiropractic care is effective for migraine. 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

 

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Additional Topics: Neck Pain

 

Neck pain is a common complaint which can result due to a variety of injuries and/or conditions. According to statistics, automobile accident injuries and whiplash injuries are some of the most prevalent causes for neck pain among the general population. During an auto accident, the sudden impact from the incident can cause the head and neck to jolt abruptly back-and-forth in any direction, damaging the complex structures surrounding the cervical spine. Trauma to the tendons and ligaments, as well as that of other tissues in the neck, can cause neck pain and radiating symptoms throughout the human body.

 

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IMPORTANT TOPIC: EXTRA EXTRA: A Healthier You!

 

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Non-Invasive Treatment Modalities for Back Pain

Non-Invasive Treatment Modalities for Back Pain

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:

 

  1. A computer aided search of the Medline and Embase databases since their beginning.
  2. A search of the Cochrane Central Register of Controlled Trials (Central).
  3. Screening references given in relevant systematic reviews and identified trials.
  4. 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 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

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

 

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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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IMPORTANT TOPIC: EXTRA EXTRA: Treating Sciatica Pain

 

 

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Close Accordion
What is Spinal Decompression Therapy? | Eastside Chiropractor

What is Spinal Decompression Therapy? | Eastside Chiropractor

Spinal decompression therapy involves the stretching of the spine, using a traction table or similar device, with the objective of relieving back pain and/or leg pain.

 

What is spinal decompression therapy?

 

This process is known as nonsurgical, spinal decompression therapy (as opposed to surgical spinal decompression like laminectomy and microdiscectomy). This article offers an overview of nonsurgical spinal decompression therapy and its role in treatment of lower back pain and neck pain.

 

Theory of Spinal Decompression Therapy

 

Spinal decompression devices use the exact fundamental principle of spinal traction that’s been provided by chiropractors, osteopaths, and other appropriately trained health professionals for many decades. Both traction and decompression therapies are applied together with the aims of relieving pain and promoting the best healing environment for bulging, degenerating, or herniated discs.

 

Spinal decompression is a type of traction treatment applied to the spine in an attempt to result in several theoretical benefits such as to create a negative intradiscal pressure to promote retraction or repositioning of the herniated or bulging disc material and to produce a reduce pressure in the disc that will cause an influx of recovery nutrients and other substances into the disk.

 

Clinical Evidence

 

While the fundamental concept of spinal decompression is broadly accepted as legitimate, there’s a shortage of evidence supporting decompression therapy as being efficacious. There are a number of dangers.

 

Though some studies that don’t include control groups conclude that decompression treatment is effective, the few that do normally conclude that mechanized spinal decompression is not any greater than sham decompression. Thus, there’s insufficient evidence that spinal decompression therapy is as effective, or even more effective, compared to less expensive manual approaches in treating back pain or injured herniated discs.

 

An overview of medical literature so far suggests that most clinical trials assessing the effectiveness of spinal decompression therapy or traction were lacking in a couple of regions, such as inadequate numbers of topics to create a statistically valid conclusion, lack of blinding (the individual or provider knows the therapy given), no regard to a placebo group (known as a sham controlled study), or absence of comparison to a treatment substitute. At the time of this report, few clinical studies of spinal decompression therapy have been published in peer reviewed journals.

 

How Spinal Decompression Works

 

In nonsurgical spinal decompression therapy, the spine is relaxed and stretched intermittently in a controlled way. The concept is that this process creates a negative intradiscal pressure (pressure inside the disc itself), which is thought to have two possible benefits: pull the herniated or bulging disc material back into the disk; and promote the passage of healing nutrients, into the disc and fosters a better recovery environment.

 

Spinal Decompression Session

 

During spinal decompression treatment for the lower spine (lumbar spine), patients stay clothed and lie on a motorized table, the lower half of that which can move. First, a�harness is placed round the hips and can be connected to the lower table close to the toes. The top region of the table then remains in a fixed position while the lower part, where the individual is harnessed, slides back and forth to offer the traction and relaxation.

 

One difference between different decompression therapies is the patient’s place on the table:

 

  • Some devices place the patient in the prone position on the desk, lying down face (e.g. VAX-D)
  • Some devices have the patient lying supine, face up (e.g. DRX9000)

 

The patient shouldn’t feel pain during or after the decompression therapy although they should feel stretch in the spine.

 

Treatment Collection and Costs

 

While spinal decompression therapy could be advocated as a potential treatment for a number of lower back pain conditions, just like all lower back pain remedies, it’s the patient’s decision whether or not to have the therapy. Although the risk is reduced, the benefit of these treatments isn’t established.

 

Decompression therapy generally consists of a series of 15 to 30 treatments, lasting 30 to 45 minutes per day, within a four to four six-week period. Sessions are conducted at the practitioner’s office. The price of each session generally ranges from $30 to $200, meaning that a recommended series of remedies will generally cost from $450 to $6,000. Although insurers may cover grip, decompression therapy isn’t usually allowed although they are almost the same.

 

Sessions may include additional treatment modalities, such as electric stimulation, ultrasound, and cold and/or heat treatment applied during or after the process. Recommendations may also incorporate drinking up to some half-gallon of water per day, remainder, utilizing nutritional supplements, or performing exercises at home to boost strength and mobility. Research and find chiropractors in your area that could help relieve your back and neck discomfort.

 

The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss options on the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .�
 

By Dr. Alex Jimenez

 

Additional Topics: Wellness

 

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

 

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Chiropractic Treatment Plan for Chronic Pain | Eastside Chiropractor

Chiropractic Treatment Plan for Chronic Pain | Eastside Chiropractor

Chiropractic is a healthcare profession devoted to the nonsurgical treatment of ailments of the nervous system and/or musculoskeletal system. Chiropractors keep a focus on therapy and manipulation of surrounding structures.

 

What can chiropractic care treat?

 

Many studies have concluded that massage therapies widely used by chiropractors are effective for treating lower back pain, in addition to for therapy of lumbar herniated disk for radiculopathy and neck pain, among other ailments.

 

In fact, when patients using non-specific chronic low back pain have been treated by physicians, the long-term result is enhanced by obtaining maintenance spinal manipulation following the initial intensive manipulative treatment.

 

Core Chiropractic Treatment Plan

 

The center of chiropractic usually involves treatment of common lower back pain conditions through manual therapy:

 

  • Spinal manipulation and manual manipulation. This type of manual manipulation identifies a short lever arm push that is applied to vertebra. It is also commonly called “chiropractic adjustment”.
    There is firm literature support for chiropractic treatment of lower back pain. Many of the guidelines that are published urge manipulation to be contained in the therapy strategy in the maintenance of back pain.
  • Mobilization. Mobilization describes velocity manipulation, motion and stretching of the muscles and joints, with the goal of increasing the assortment of movement.

 

What Does a Chiropractic Treatment Plan Consist Of?

 

Most chiropractors start treatment throughout the patient’s first visit, although some might wait until the next appointment of the practice. Chiropractic therapy goals and recommendations can include some or all of the following:

 

  • Adjustments to key joint dysfunctions
  • Modalities to enhance soft tissue healing and pain management, such as ultrasound, electric stimulation, and grip
  • Strengthening and/or stretching exercises to improve muscle balance, strength, and coordination
  • Patient instruction to improve posture and motor controller, as well as potentially reduce anxiety
  • Other treatments like massage, heat/cold application, and education on ergonomics and nourishment.

 

Goals of Chiropractic Care

 

The chiropractor will establish Certain goals for a patient’s individual plan for therapy:

 

  • Short-term goals typically include reducing pain and restoring normal joint function and muscle balance
  • Long-term targets include assigning functional independence and tolerance to normal activities of daily living.
    To accomplish these goals, a particular number of chiropractic visits will be recommended.

 

For most kinds of lower back pain, a treatment recommendation of 1 to 3 chiropractic visits per week for 2 to 4 weeks will be prescribed, followed closely by a re-examination from the chiropractor.

 

Chiropractic Evaluation of the Treatment

 

In the re-evaluation, the chiropractic physician will Assess the response to treatment and decide whether to:

 

  • Continue chiropractic treatment, if appropriate
  • Release the Individual from chiropractic care, if treatment goals have been met
  • Refer the patient to another health care specialist if treatment goals have not been fulfilled.
  • Chiropractic adjustment (also referred to as spinal manipulation) is a popular and recognized pain relief therapy for many types of lower back pain, sciatica, and neck pain. Knowing what to anticipate from the first visit might help an individual get the maximal benefit from treatment.

 

Since this profession has an unusually large selection of practice philosophies and chiropractic methods, people should feel comfortable asking all of the questions necessary to comprehend the chiropractic examination, diagnosis, and therapy plan.

 

The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss options on the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .�
 

By Dr. Alex Jimenez

 

Additional Topics: Wellness

 

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

 

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Interventional Chronic Pain Management Treatments | Central Chiropractor

Interventional Chronic Pain Management Treatments | Central Chiropractor

Chronic pain is known as pain that persists for 12 weeks or even longer, even after pain is no longer acute (short-term, acute pain) or the injury has healed. Of course there are many causes of chronic pain that can influence any level of the spine, cervical (neck), mid back (thoracic), lower spine (lumbar), sacral (sacrum) or some combination of levels.

 

What treatments do interventional pain management specialists perform?

 

Oftentimes, early and aggressive therapy of chronic neck or back pain can earn a difference that is life-changing. But remember that knowledge is power: Be certain that you know your choices. There are various treatment procedures and treatments available for chronic pain, each completed by a treatment specialists. Interventional pain management specialist treatments may be a fantastic solution for some people with chronic pain symptoms.

 

Interventional Pain Management Specialists

 

Interventional pain management (IPM) is a special field of medicine that uses injections and small processes to help patients control their own chronic pain. Interventional pain management specialists are trained to diagnose and cure ailments, and their goal is to improve patients’ quality of life.

 

IPM’s Role in Treating Chronic Back Pain

 

Pain control plays a big role in chronic pain since many forms of pain can’t be cured, so pain victims must find out how to live with and work around the pain. A pain management specialist can help them locate the pain relief that they need to work in the daily. The interventional treatments are part of a multi-disciplinary approach that might include use of medications, psychology, and therapy. Part of IPM is currently finding treatments that works best for your treatment or combination. Some potential interventional pain management therapies are:

 

Injections

 

Your interventional pain management expert will have you try injections, which send anti inflammatory medications and strong pain-relieving straight. A few examples of injections used for chronic pain are:

 

Epidural steroid injection: This is one of the most commonly used injections. An epidural steroid injection (ESI) aims the epidural space, that is the space surrounding the membrane which holds the spinal fluid around the spinal cord and nerve roots. Nerves traveling through the epidural area and then branch out to other parts of your body, like your thighs. When a nerve root is compressed (pinched) from the epidural space, you’ll have pain that travels down your spine and into your legs (commonly called sciatica, even though the technical medical term is radiculopathy). An epidural steroid injection sends steroids right to the nerve root that’s inflamed. You need 2-3 injections; normally, you shouldn’t have that because of the potential side effects of the steroids.

 

Facet joint injection: Also called facet blocks, facet joint injections are helpful in case your facet joints are causing annoyance. Facet joints in your back allow you to move and provide stability. Though, you will have pain, if they get inflamed. The joint wills numb and can lower your pain.

 

Sacroiliac joint injection: The joint is where your pelvis and spine come and also an aching sacroiliac joint can be extremely debilitating. The injection may reduce inflammation and pain.

 

The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss options on the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900
 

By Dr. Alex Jimenez

 

Additional Topics: Wellness

 

Overall health and wellness are essential towards maintaining the proper mental and physical balance in the body. From eating a balanced nutrition as well as exercising and participating in physical activities, to sleeping a healthy amount of time on a regular basis, following the best health and wellness tips can ultimately help maintain overall well-being. Eating plenty of fruits and vegetables can go a long way towards helping people become healthy.

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TRENDING TOPIC: EXTRA EXTRA: New PUSH 24/7�? Fitness Center

 

 

Herniated Disc Diagnosis: Exams and Imaging | Scientific Chiropractor

Herniated Disc Diagnosis: Exams and Imaging | Scientific Chiropractor

A herniated disc can lead to pain as well as disrupt your daily activities, as you likely know. That is probably what brings you to the office of the doctor: You have back pain or neck pain, and you’d love to understand why.

 

Your doctor will ask you questions and execute a few exams. This is to try to find the origin of your pain and also to find out which intervertebral disks are herniated. An accurate diagnosis will help your doctor develop a treatment plan method to help you recover and to handle your herniated disc pain and other spine symptoms.

 

Physical Exam: Herniated Disc Diagnosis

 

As part of the physical exam, your doctor will ask about your current symptoms and remedies you have already tried for your pain. Some average herniated disc diagnostic questions include:

 

  • When did the pain begin? Where’s the pain (cervical, thoracic or mid-back, or lumbar or lower back)?
  • What activities did you lately do?
  • What do you do for your herniated disc pain?
  • Can the disc herniation pain radiate or travel to other parts of your body?
  • Does anything reduce the disk pain or make it even worse?

 

Your doctor may also observe your position, range of movement, and physical condition both lying down and standing up. Movement that causes pain will be noticed. A Las�gue evaluation, also referred to as the Straight-Leg Raising evaluation, may be accomplished. You’ll be asked to lie down and extend your knee with your hip bent. If it produces pain or makes your pain worse, this may indicate a herniated disc.

 

With a herniated disc (or a bulging or ruptured disc), you might feel stiff and may have lost your normal spinal curvature because of muscle strain. Your physician may also feel for tightness and note the spine’s curvature and alignment.

 

Neurological Exam: Herniated Disc Diagnosis

 

Your spine specialist will also run a neurological exam, which tests your reflexes, muscle strength, other nerve changes, and pain disperse. Radicular pain (pain that travels away from the source of the pain) can increase when stress is applied directly to the affected area. You might, for instance, have sciatica; this is radicular pain that might be caused by the herniated disk. Since the disc is compressing a nerve, you might experience pain and symptoms in other areas of the body, although the origin of the pain is on your spine.

 

Imaging Tests for Herniated Discs

 

Your spine specialist may order imaging tests to help diagnose your injury or condition; you might have to see an imaging facility for those evaluations.

 

 

herniated-disc-large

 

An X-ray may demonstrate a secondhand disk space, fracture, bone spur, or arthritis, which might rule out disk herniation. A computerized axial tomography scan (a CT or CAT scan) or a magnetic resonance imaging test (an MRI) equally can show soft tissue of a bulging disk or herniateddisc. So that you may get treatment these tests will demonstrate location and the stage of the herniated discs.

 

Herniated Disc Imaging Samples - El Paso Chiropractor

 

Other Tests to Diagnose�a Herniated Disc

 

To obtain the most accurate identification, your spine specialist may order additional tests, for example:

 

  • Electromyography (EMG): He or she may order an examination known as an electromyography to measure your nerves respond, if your spine pro suspects you’ve got nerve damage.
  • Discogram or discography: A sterile procedure where dye is injected into one of your vertebral disc and seen under special conditions (fluoroscopy). The goal is to pinpoint which disk(s) might be causing your pain.
  • Bone scan: This technique generates film or computer images of bones. A very small number of radioactive substance is injected into a blood vessel throughout the blood flow. It collects on your bones and can be detected by a scanner. This procedure helps doctors detect spinal problems such as disease, a fracture, tumor, or arthritis.
  • Laboratory evaluations: Typically blood is attracted (venipuncture) and tested to determine if the blood cells are normal or abnormal. A metabolic disease which might be contributing to a back pain may be indicated by Chemical changes in the blood.

 

The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss options on the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .�Green-Call-Now-Button-24H-150x150-2.png

 

By Dr. Alex Jimenez

 

Additional Topics: Sciatica

 

Lower back pain is one of the most commonly reported symptoms among the general population. Sciatica, is well-known group of symptoms, including lower back pain, numbness and tingling sensations, which often describe the source of an individual’s lumbar spine issues. Sciatica can be due to a variety of injuries and/or conditions, such as spinal misalignment, or subluxation, disc herniation and even spinal degeneration.

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TRENDING TOPIC: EXTRA EXTRA: New PUSH 24/7�? Fitness Center

 

 

The Importance of MRI for Herniated Disc Diagnosis | Scientific Specialist

The Importance of MRI for Herniated Disc Diagnosis | Scientific Specialist

There are a number of important factors to take into consideration, such as the timing of when an MRI scan must be performed and limitations with interpretation of findings, to get an MRI scan for herniated discs.

 

To begin with, the difficulty with the results of an MRI scan, as with a number of other diagnostic studies, is that the abnormality may not always be the source of an individual’s back pain or other symptoms. Numerous studies have shown that approximately 30 percent of people in their twenties and forties have a lumbar disc herniation in their MRI scan, even though they don’t have any pain.

 

An MRI scan cannot be interpreted on its own. Everything Has to Be well-correlated into the individual patient’s condition, for example:

 

  • Symptoms (such as the duration, location, and severity of pain)
  • Any deficits in their examination

 

Another concern with MRI scans is the time of when the scan is done. When a patient has experienced the following symptoms would be the only time that an MRI scan is needed immediately:

 

  • Bowel or bladder incontinence
  • Progressive weakness due to nerve damage in the legs.

 

Herniated Disc Analysis with MRI

 

Obtaining an MRI (magnetic resonance imaging) can be an important step in correctly assessing a herniated disc in the spine. Unlike an X-ray, MRI uses a magnetic field and a computer to create and record detailed pictures of the internal workings of your entire body. This technology can also be capable of producing cross-sectional views in identifying a disc of the body, which greatly help doctors. MRI scans are based on new technology, but they have become essential in diagnosing a number of back and neck issues, such as spinal stenosis, herniated discs and bone spurs.

 

An MRI scan has a number of benefits that greatly help a herniated disc patient. The advantages of an MRI can be:

 

  • Unobtrusive
  • Painless and free of radiation
  • Can focus on a particular part of the entire body
  • Extremely accurate

 

Diagnosing Disc Herniation

 

Should you believe you have a herniated disc in the neck or back, the very first step would be to visit a physician. Your physician will have the ability to supply you with a complete evaluation and inspection of your medical history to create a identification. Following that, you may be referred to execute an MRI stabilize and to confirm the herniated disc.

 

 

 

 

At the imaging center you’ll be put to the tubular MRI machine to get a body scan. You may remain enclosed in the MRI device for up to an hour while the comprehensive scan of place where the herniated disc along the spine is completed. The MRI can reveal the exact condition of the herniated disc and surrounding arrangements. This allows your doctor to produce the treatment plan that is right for you and to understand the origin of the disc damage and pain.

 

Herniated Disc Follow-Up Treatment

 

Most patients are able to successfully treat herniated disc pain using nonsurgical standard treatments prescribed by their physician. These include relaxation, compression treatment and mild exercise. Surgery can then be explored when months or weeks of treatment do not bring a return to previous action.

 

If you’re researching surgical options and have become concerned by a number of the risks and unsuccessful results of traditional open back operation, contact a specialist. Spine surgery specialists perform minimally invasive spine surgery, including invasive stabilization surgeries and minimally invasive decompression, which can treat a number of the very acute herniated discs. They may review your MRI to determine if you are a candidate for minimally invasive spine surgery, which may help you get your life back.

 

The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss options on the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .�Green-Call-Now-Button-24H-150x150-2.png

 

By Dr. Alex Jimenez

 

Additional Topics: Sciatica

 

Lower back pain is one of the most commonly reported symptoms among the general population. Sciatica, is well-known group of symptoms, including lower back pain, numbness and tingling sensations, which often describe the source of an individual’s lumbar spine issues. Sciatica can be due to a variety of injuries and/or conditions, such as spinal misalignment, or subluxation, disc herniation and even spinal degeneration.

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TRENDING TOPIC: EXTRA EXTRA: New PUSH 24/7�? Fitness Center

 

 

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