Back Clinic Conditions Treated. Chronic Pain, Auto Accident Care, Back Pain, Low Back Pain, Back Injuries, Sciatica, Neck Pain, Work Injuries, Personal Injuries, Sports Injuries, Migraine Headaches, Scoliosis, Complex Herniated Discs, Fibromyalgia, Wellness & Nutrition, Stress Management, and Complex Injuries.
At El Paso’s Chiropractic Rehabilitation Clinic & Integrated Medicine Center, we are focused on treating patients after debilitating injuries and chronic pain syndromes. We focus on improving your ability through flexibility, mobility, and agility programs tailored for all age groups and disabilities.
If Dr. Alex Jimenez feels you need other treatment, then you will be referred to a clinic or Physician that is best suited for you. Dr. Jimenez has teamed with the top surgeons, clinical specialists, medical researchers, and premiere rehabilitation providers to bring El Paso the top clinical treatments to our community. Providing the top non-invasive protocols is our priority. Clinical insight is what our patients demand in order to give them the appropriate care required. For answers to any questions you may have please call Dr. Jimenez at 915-850-0900
These assessment and treatment recommendations represent a synthesis of information derived from personal clinical experience and from the numerous sources which are cited, or are based on the work of researchers, clinicians and therapists who are named (Basmajian 1974, Cailliet 1962, Dvorak & Dvorak 1984, Fryette 1954, Greenman 1989, 1996, Janda 1983, Lewit 1992, 1999, Mennell 1964, Rolf 1977, Williams 1965).
Clinical Application of Neuromuscular Techniques: Infraspinatus
Assessment of Shortness in the Infraspinatus
Infraspinatus shortness test (a) The patient is asked to reach upwards, backwards and across to touch the upper border of the opposite scapula, so producing external rotation of the humeral head. If this effort is painful infraspinatus shortness should be suspected.
Infraspinatus shortness test (b) (see Fig. 4.37 below) Visual evidence of shortness is obtained by having the patient supine, upper arm at right angles to the trunk, elbow flexed so that lower arm is parallel with the trunk, pointing caudad with the palm downwards. This brings the arm into internal rotation and places infraspinatus at stretch. The practitioner ensures that the shoulder remains in contact with the table during this assessment by means of light compression.
Figure 4.37 Assessment and self-treatment position for infraspinatus. If the upper arm cannot rest parallel to the floor, possible shortness of infraspinatus is indicated.�If infraspinatus is short, the lower arm will not be capable of resting parallel with the floor, obliging it to point somewhat towards the ceiling.
Assessment for Infraspinatus Weakness
The patient is seated. The practitioner stands behind. The patient�s arms are flexed at the elbows and held to the side, and the practitioner provides isometric resistance to external rotation of the lower arms (externally rotating them and also the humerus at the shoulder). If this effort is painful, an indication of probable infraspinatus shortening exists.
The relative strength is also judged. If weak, the method discussed by Norris (1999) should be used to increase strength (isotonic eccentric contraction performed slowly).
NOTE: In this as in other tests for weakness there may be a better degree of cooperation if the practitioner applies the force, and the patient is asked to resist as much as possible. Force should always be built slowly and not suddenly.
MET Treatment of Infraspinatus
Figure 4.38 MET treatment of infraspinatus. Note that the practitioner�s left hand maintains a downward pressure to stabilise the shoulder to the table during this procedure.
The patient is supine, upper arm at right angles to the trunk, elbow flexed so that lower arm is parallel with the trunk, pointing caudad with the palm downwards. This brings the arm into internal rotation and places infraspinatus at stretch.
The practitioner ensures that the posterior shoulder remains in contact with the table by means of light compression. The patient slowly and gently lifts the dorsum of the wrist towards the ceiling, against resistance from the practitioner, for 7�10 seconds.
After this isometric contraction, on relaxation, the forearm is taken towards the floor (combined patient and practitioner action), so increasing internal rotation at the shoulder and stretching infraspinatus (mainly at its shoulder attachment).
Care needs to be taken to prevent the shoulder from rising from the table as rotation is introduced, so giving a false appearance of stretch in the muscle. In order to initiate stretch of infraspinatus at the scapular attachment, the patient is seated with the arm (flexed at the elbow) fully internally rotated and taken into full adduction across the chest. The practitioner holds the upper arm and applies sustained traction from the shoulder in order to prevent subacromial impingement.
The patient is asked to use a light (20% of strength) effort to attempt to externally rotate and abduct the arm, against resistance offered by the practitioner, for 7�10 seconds.
After this isometric contraction, and with the traction from the shoulder maintained, the arm is taken into increased internal rotation and adduction (patient and practitioner acting together) where the stretch is held for at least 20 seconds.
Dr. Alex Jimenez offers an additional assessment and treatment of the hip flexors as a part of a referenced clinical application of neuromuscular techniques by Leon Chaitow and Judith Walker DeLany. The scope of our information is limited to chiropractic and spinal injuries and conditions. To discuss 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.
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]
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)
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.
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).
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).
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.
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. 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.
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.
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
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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Defeat Chronic Pain: If you are one of the estimated 50 to 100 million Americans who struggles with Chronic Pain, you are aware of just how miserable and life-altering it can be. There is not a single area of you life that remains unaffected. You no longer sleep well. Your SEX LIFE is non-existent. Everyday activities have become your own personal �Mount Everest �. You cannot concentrate because the pain IS ALWAYS ON YOUR MIND. It is wearing you out, physically, mentally, and emotionally. It’s sapping your ability to think clearly or make decisions. In short we’re here to defeat chronic pain.
People can see the pain on your face and in your eyes. Chronic Pain and the inability to do the things you love, is making you feel DEPRESSED (not the other way around like your doctor may have suggested). Recent studies have even shown that brains of people suffering with Chronic Pain, show patterns of atrophy that are virtually indistinguishable from what is seen in patients with dementia or ALZHEIMER’S. In fact, a recent study from a prominent Canadian University showed that Chronic Pain causes the brain to degenerate at almost 10 times the rate of someone without pain!
Although Chronic Pain may seem hopeless, there are some things that you can do to help yourself � even though your doctor undoubtedly failed to educate you in this regard. Some of the most basic of these include eating only healthy foods (I recommend a PALEO DIET), taking only WHOLE FOOD SUPPLEMENTS, drinking more WATER, giving up the CIGARETTES, and EXERCISING to the degree that you can (difficult when suffering with Chronic Pain or FIBROMYALGIA).
Although DOING THESE SIMPLE THINGS will certainly help a large percentage who suffer and be able to defeat chronic pain; there is a significant percentage of you whose pain is not greatly diminished by these measures. It is for you that I created this website. But before we move on to treatment of Chronic Pain, you must first understand what Chronic Pain is and how it really works.
Defeat Chronic Pain: It Works Like This
For years, neuro-scientists have known that Chronic Pain can cause brain atrophy (shrinkage) that is indistinguishable from Alzheimer�s or Dementia. More recently, the prestigious Journal of Neuroscience reported research from McGill University showing that, “The longer the individual has had Fibromyalgia, the greater the gray matter loss, with each year of Fibromyalgia being equivalent to 9.5 times the loss in normal aging”. Think about this statement for a moment. Every single year you live with some sort of CHRONIC PAIN SYNDROME (or syndromes as the case may be) is the equivalent of nearly 10 times the brain loss seen in the normal aging process. Re-read this paragraph until the urgency of your situation sinks in!
Although there are several types of pain (the study of Chronic Pain can get extremely complex), we are going to try and keep this as simple as possible. For our purposes, there are two types of Chronic Pain. It has to do with where the pain comes from. Chronic Pain originates in one of the two following areas.
The Central Nervous System
The Body
As we will discuss shortly, Chronic Pain that arises in the CNS is frequently ‘learned’ pain. Let me explain. In order to learn how to SHOOT FREE THROWS, use chop sticks, PLAY THE PIANO, speak Swahili, you have to practice. Everyone remembers the old adage; Practice makes Perfect. If you stimulate pain pathways in the Brain & Nervous System long enough, or are exposed to enough stressors in your life (CHEMICAL, AUTOIMMUNE, EMOTIONAL, DIETARY, FOOD SENSITIVITIES, PHYSICAL, BACTERIAL, VIRAL, PARASITIC, FUNGAL, MOLD, ELECTROMAGNETIC, etc), you can alter the way your Brain and Central Nervous System function.
Hopefully your pain, even though severe, is still Type II (THE THREE TYPES OF PAIN). As people start losing control of numerous areas of physiology (DIGESTION, HORMONAL, IMMUNITY, BLOOD SUGAR REGULATION, HYPERSENSITIVITY, DYSBIOSIS, etc), the problems ramp up. Over time this pain can (will) become locked into the brain. Although pathological Pain Syndromes arising from a malfunctioning CNS are not the most common causes of Chronic Pain, if this is where you are at, you are going to have to find a way to deal with these underlying issues (FUNCTIONAL NEUROLOGY can be a fantastic starting point). Although I provide information that helps many people help themselves with the severe metabolic and neurological problems, this website is chiefly devoted to defeat chronic Pain that is not locked into the Brain, but is instead originating from the body (Type II Pain).
Defeat Chronic Pain: Nociception
“Simple Nociception” is the most basic type of pain. If someone steps on your toe, it hurts. This is normal, and means that your nervous system is functioning properly. Get the person off your toe, and the pain goes away — almost immediately. Simple. There are several different types of Nociceptive Pain, but the one that we are most concerned about on this website is the one that has to do with ‘deep’ musculoskeletal pain, otherwise known as Deep Somatic Pain (Greek �Soma� = body). Deep Somatic Pain is pain that originates in tissues that are considered to be ‘deep’ in the body. Although we do not always think of many of these tissue types as being deep, this category includes things like LIGAMENTS, TENDONS, MUSCLES, FASCIA, blood vessels, and bones. There are two main types of Nociceptors, chemical and mechanical.
I. Chemical Nociception
The Chemical Nociceptors are stimulated by noxious chemicals. The chief of these are the chemicals we collectively refer to as INFLAMMATION (bear in mind that once Inflammation is involved, we begin moving away from Type I pain and into Type II pain — Nociception is still involved, but so is the Inflammatory Cascade). Inflammation is actually made up of a large group of chemicals manufactured within your body as part of the normal Immune System response. They have names like prostaglandins, leukotrienes, histamines, cytokines, kinins, etc, etc, etc. When these chemicals are out of increased beyond what’s needed for normal tissue repair, the result will be a whole host of health problems —- and Chronic Pain.
Although “SYSTEMIC INFLAMMATION” is at the root of the vast majority of America’s health problems (DIABETES, CANCER, FIBROMYALGIA, THYROID PROBLEMS, ARTHRITIS, HEART DISEASE, and numerous others), you will soon see that even though Inflammation is always involved with the tissues of the “Deep Soma,” it sometimes gets more credit than it deserves. However, you also have to be aware that exposing MICROSCOPIC SCAR TISSUE to chronic inflammation can potentially hyper-sensitize nerves. This hypersensitization makes the nerves within Scar Tissue as much as 1,000 times more pain sensitive than normal (the work of the famous neurologist, DR. CHAN GUNN).
INCREASED TISSUE ACIDITY (usually caused by hypoxia — diminished tissue oxygen levels) is another common form of Chemical Nociception. This frequently occurs as the result of a JUNKY DIET, but is also caused by relentless Mechanical / Neurological / Immune System Dysfunction. It is a big reason that my Decompression Protocols utilize OXYGEN THERAPY extensively.
II. Mechanical Nociception
As you can imagine, Mechanical Dysfunction stimulates the Mechanical Nociceptors. This group of nociceptors (pain receptors) is stimulated by constant mechanical stress in the tissues of the Deep Soma — particularly ligaments, tendons, and fascia. Mechanical tension, mechanical deformation, mechanical pressure, etc are the things that cause Mechanical Nociception, which can in turn, cause pain — chronic, unrelenting, pain. Remove the offending mechanical stressor, and you can oftentimes remove the pain. Sounds simple, doesn�t it? Unfortunately, nothing is ever quite as simple as it initially appears.
Be aware that Nociceptive Pain can actually become Brain-Based over time. This is called ‘Supersensitivity’ and is caused by alterations in the Brain and Central Nervous System that perpetuate the pain cycle (many in the medical community are calling it CENTRALIZATION OR CENTRAL SENSITIZATION. In Mechanical Nociception, even though the injured tissue has, according to all of the medical tests, HEALED, it has healed improperly; i.e. microscopic scar tissue and tissue adhesion — particularly in the FASCIA. I probably do not need to tell you that this can be really really bad news — particularly because it is a significant feature of what I call “CHRONIC PAIN’S PERFECT STORM“.
As nerve function and PROPRIOCEPTION become increasingly fouled up, degenerative arthritis and joint deterioration begin to set in (HERE). Because of involvement in the Brain or Central Nervous System, this kind of pain is often referred to as Neuropathic Pain or Neruogenic Pain. Sometimes people end up with HYPERALGIA (Extreme sensitivity to pain. Stimulus that should cause a little pain, causes extraordinary amounts of pain). Or they end up with ALLODYNIA (Stimulus which do not normally elicit any pain at all, now causes pain). Sometimes these two overlap. Stay with me and you will begin to understand why.
Defeat Chronic Pain: Hypersensitized Nerves Relationship To Injured Or Damaged Fascia
Think of nerve endings as the twigs at the very end of a tree limb. Nerves (just like a tree) begin with a large trunk, which splits / divides into smaller and smaller branches until eventually you arrive at the end � the tiny twig (or nerve ending) at the end of the very smallest branches.
If you have ever seen a �topped� tree, you can understand what happens to nerve endings that are found in microscopic scar tissue. Professional Tree Trimmers cut (or �top�) the largest branches just above where the trunk splits into two or three limbs. What happens to these stubs? Instead of having limbs that continue to branch out and divide into ever-smaller limbs in a normal fashion, you get a stub or stump, that in a short matter of time, swells up and has hundreds of tiny twig-like limbs growing from it. �Topping� stimulates the growth of twigs from the stump. The injured nerves found in microscopic scar tissue act in much the same way.
As the larger nerves that are found in soft tissues are injured, you end up with an inordinate number of immature nerve endings (twigs) growing out of an inflamed nerve �stump�. As you might imagine, extra pain receptors are never a good thing! And because there in Inflammation present, this often leads to Microscopic Scar Tissue, which, even though it is up to 1,000 times more pain-sensitive than normal tissue, cannot be seen with even the most technologically advance imaging techniques such as CT / MRI (HERE). This is a commonly seen phenomenon in Facial Adhesions, and is why even though the people living this nightmare believe that because their pain is so severe that it should make their MRI “Glow Red”, it shows nothing. This tends to lead to deer-in-the-headlight looks when you ask your doctor what might be causing your pain, not to mention accusations of malingering, drug seeking, or attempting to get on Disability.
Defeat Chronic Pain: Nerves Are Like Tree Branches
Uninjured Nerves
Photo by Stephen McCulloch
Injured Nerves
Photo by Linda Bailey
Defeat Chronic Pain: Fascial Adhesions
Microscopic Scar Tissue & Chronic Pain
One of the biggest revelations for many people suffering with Chronic Pain is the absurd numbers of CHRONIC PAINSYNDROMES brought on by microscopic scarring of the FASCIA. It gets even worse once you realize that this Fascia is the most pain-sensitive tissue in the body —- yet it does not show up on even the most technologically advanced imaging techniques, including MRI. Simply read our “Fascia” page to see why microscopic scarring of this specific “Connective Tissue” is at the root of all sorts of Chronic Pain Cases — not to mention ILL HEALTH.
Have you ever experienced low back pain? If you haven’t already, there’s a high probability you will present at least one case of back pain sometime during your lifetime. Back pain is one of the most prevalent spine health issues reported among the population of the United States, affecting up to 80 percent of Americans at some point in their lives. Back pain is not a specific disease, rather it is a symptom which may develop as a result of a variety of injuries and/or conditions.�Although most cases typically resolve on their own, the effective treatment of acute low back pain is essential towards preventing chronic low back pain.
Chiropractors and physical therapists frequently utilize a similar series of treatment methods, such as spinal adjustments and manual manipulations as well as massage and physical therapy, to help treat symptoms of back and low back pain. Many healthcare professionals, however, have started using the McKenzie method to manage acute back pain. The purpose of the following article is to educate patients on the effectiveness of the McKenzie method for acute non-specific low back pain.
The McKenzie Method for the Management of Acute Non-Specific Low Back Pain: Design of a Randomised Controlled Trial
Abstract
Background
Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.
Physiotherapists commonly use a system of diagnosis and exercise prescription called the McKenzie Method to manage patients with LBP. However, there is insufficient evidence to support the use of the McKenzie Method for these patients. We have designed a randomised controlled trial to evaluate whether the addition of the McKenzie Method to general practitioner care results in better outcomes than general practitioner care alone for patients with acute LBP.
Methods/Design
This paper describes the protocol for a trial examining the effects of the McKenzie Method in the treatment of acute non-specific LBP. One hundred and forty eight participants who present to general medical practitioners with a new episode of acute non-specific LBP will be randomised to receive general practitioner care or general practitioner care plus a program of care based on the McKenzie Method. The primary outcomes are average pain during week 1, pain at week 1 and 3 and global perceived effect at week 3.
Discussion
This trial will provide the first rigorous test of the effectiveness of the McKenzie Method for acute non-specific LBP.
Background
In Australia, low back pain (LBP) is the most frequently seen musculoskeletal condition in general practice and the seventh most frequent reason for consulting a physician[1,2]. According to the Australian National Health Survey, 21% of Australians reported back pain in 2001; additionally, the Australian Bureau of Statistic’s 1998 Survey of Disability, Ageing and Carers estimated that over one million Australians suffer from some form of disability associated with back problems[1].
LBP poses an enormous economic burden to society in countries such as the USA, UK and The Netherlands[3]. In the largest state in Australia, New South Wales, back injuries account for 30% of the cost of workplace injuries, with a gross incurred cost of $229 million in 2002/03[4]. It is expected that most people with an acute episode of LBP will improve rapidly, but a proportion of patients will develop persistent lower levels of pain and disability[5,6]. Those patients with chronic complaints are responsible for most of the costs[6]. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.
There is a growing concern about effectiveness of treatments for LBP, as reflected in the large number of systematic reviews published in the last 5 years addressing this issue. [7-12]. Despite the large amount of evidence regarding LBP management, a definitive conclusion on which is the most appropriate intervention is not yet available. A comparison of 11 international clinical practice guidelines for the management of LBP showed that the provision of advice and information, together with analgesics and NSAIDs, is the approach consistently recommended for patients with an acute episode[13]. Most guidelines do not recommend specific exercises for acute LBP because trials to date have concluded that it is not more effective than other active treatments, or than inactive or placebo treatments[8]. However, some authors have suggested that the negative results observed in trials of exercises are a consequence of applying the same exercise therapy to heterogeneous groups of patients. [14-16]. This hypothesis has some support from a recent high-quality randomised trial in which treatment based on a diagnostic classification system led to larger reductions in disability and promoted faster return to work in patients with acute LBP than the therapy recommended by the clinical guidelines[17].
In 1981, McKenzie proposed a classification system and a classification-based treatment for LBP labelled Mechanical Diagnosis and Treatment (MDT), or simply McKenzie Method[18]. Of the large number of classification schemes developed in the last 20 years [19-26], the McKenzie Method has the greatest empirical support (e.g. validity, reliability and generalisability) among the systems based on clinical features[27] and therefore seems to be the most promising classification system for implementation in clinical practice.
Physiotherapists commonly adopt the McKenzie Method for treating patients with LBP[28,29]. A survey of 293 physiotherapists in 1994 found that 85% of them perceived the McKenzie Method as moderately to very effective[28]. Nevertheless, a recent systematic review concluded that there is insufficient evidence to evaluate the effectiveness of the McKenzie Method for patients with LBP [30]. A critical concern is that most trials to date have not implemented the McKenzie Method appropriately. The most common flaw is that all trial participants are given the same intervention regardless of classification, an approach contradictory to the principles of McKenzie therapy.
The primary aim of this trial is to evaluate whether the addition of the McKenzie Method to general practitioner (GP) care results in better outcomes than GP care alone for patients with acute non-specific LBP when effect is measured in terms pain, disability, global perceived effect, and persistent symptoms.
Methods
The University of Sydney Human Research Ethics Committee granted approval for this study.
Study Sample
One hundred and forty eight participants with a new episode of acute non-specific LBP who present to GPs will be recruited for the study. A new episode of LBP will be defined as an episode of pain lasting longer than 24 hours, preceded by a period of at least one month without LBP and in which the patient did not consult a health care practitioner[31]. Participants will be screened for eligibility at their first appointment with the GP according to the inclusion and exclusion criteria.
Inclusion Criteria
To be eligible for inclusion, participants must have pain extending in an area between the twelfth rib and buttock crease (this may or may not be accompanied by leg pain); pain of at least 24 hours duration; pain of less than 6 weeks duration; and they need to be eligible for referral to private physiotherapy practice within 48 hours.
Exclusion Criteria
Participants will be excluded if they have one of the following conditions: nerve root compromise (defined as 2 positive tests out of sensation, power and reflexes for the same spinal nerve root); known or suspected serious spinal pathology; spinal surgery within the preceding 6 months; pregnancy; severe cardiovascular or metabolic disease; or inability to read and understand English.
Recruiting GPs will record the number of patients who are invited to participate, the number who decline to participate, and the number of screened patients who are ineligible and their reasons for declining participation or ineligibility. Written consent will be obtained for each participant.
Subjects who volunteer to participate and satisfy the eligibility criteria will receive baseline treatment and then be randomly allocated to one of the study groups. To ensure equal-sized treatment groups, random permuted blocks of 4�8 participants will be used[32]. Randomisation will be stratified by Workcover compensation status. The stratified random allocation schedule will be generated by a person not otherwise involved in recruitment, assessment or treatment of subjects and the randomisation sequence will be placed in sequentially numbered, sealed envelopes. The flow of participants through the study is detailed in Figure ?1.
Figure 1: Flow of participants through the study. Legend: GP � General practitioner; NRS � Numeric pain rating scale; PSFS � Patient-specific functional scale; RMQ � Roland-Morris questionnaire; GPE � Global perceived effect; LBP � Low back pain.
Dr. Alex Jimenez’s Insight
In the management of low back pain, the attitudes, beliefs and treatment preferences of chiropractors, as well as that of physical therapists, can determine the most effective outcome measures in the care of patients with different types of spinal health issues. According to the following evidence-based research studies, the McKenzie method has been deemed to be one of the most useful treatment approaches for managing symptoms in patients with back and low back pain. Exercise and physical activity is also one of the most common treatment preferences for improving an individual’s strength, mobility and flexibility. Every healthcare professional varies in respect to their specific treatment preferences. These variations emphasize the need to identify the most effective treatment approach to guarantee proper treatment of LBP.
Outcome Measures
The McKenzie protocol is thought to promote rapid symptom improvement in patients with LBP[33,34] and this is one of the reasons that therapists choose this therapy. Therefore it is important to focus assessment on short-term outcomes. The primary outcomes will be:
Usual pain intensity over last 24 hours recorded each morning in a pain diary over the first week. Pain will be measured on a 0�10 numerical rating scale (NRS). The unit of analysis will be the mean of the 7 measures[35];
Usual pain intensity over last 24 hours (0�10 NRS) recorded at 1 and 3 weeks[35];
Global perceived effect (0�10 GPE) recorded at 3 weeks.
The secondary outcomes will be:
Global perceived effect (0�10 GPE) recorded at 1 week;
Patient-generated measure of disability (Patient-Specific Functional Scale; PSFS) recorded at 1 and 3 weeks[36];
Condition-specific measure of disability (Roland Morris Questionnaire; RMQ) recorded at 1 and 3 weeks[37];
Number of patients reporting persistent back pain at 3 months.
Following the screening consultation in which the inclusion and exclusion criteria are assessed, the GP will supervise the baseline measurement of pain. All patients will then receive an assessment booklet and a pre-paid envelope in which all other self-assessed outcome measures are to be recorded and sealed. One member of the research team will contact patients by telephone within 24 hours of the consultation with the GP in order to give explanations regarding the appropriate form of filling in the assessment booklet. At this time, other baseline outcomes will be recorded and then the patient will be randomised to study groups. The patient will be advised to keep the booklet at home, to seal it into the pre-paid envelope after the final assessment and mail the sealed envelope to the research team. To ensure the proper use of the assessment booklet and to avoid loss of data due to non-returned booklets, a blinded assessor will contact all patients by telephone 9 and 22 days after the consultation with the GP to collect patient’s answers from the 1st week and 3rd week assessments, respectively.
The procedure for obtaining outcome data will be followed for all participants, regardless of compliance with trial protocols. At 3 months, data regarding the presence of persistent (chronic) symptoms will be collected by telephone. Participants will be asked to answer the following yes-no question: “During the past 3 months have you ever been completely free of low back pain? By this I mean no low back pain at all and would this pain-free period have lasted for a whole month”. Those answering no will be considered to have persistent LBP. Information on additional treatment and the direct costs with low back pain management will also be collected at 3 months.
A secondary analysis will be performed on predictors of response to McKenzie treatment and prediction of chronicity. This will involve the measurement of participants’ expectation about the helpfulness of both treatments under investigation as well as information on the occurrence of the centralisation phenomenon. Expectation will be recorded prior to randomisation according to the procedures described by Kalauokalani et al[38].
Treatments
All participants will receive GP care as advocated by the NHMRC guideline for the management of acute musculoskeletal pain[2]. Guideline-based GP care consists of providing information on a favourable prognosis of acute LBP and advising patients to stay active, together with the prescription of paracetamol. Patients randomised to the experimental group will be referred to physiotherapy to receive the McKenzie Method. A research assistant not involved in the assessment or treatment of subjects will be responsible for the randomisation process and will contact therapists and patients to arrange the first physiotherapy session. The McKenzie treatment will be delivered by credentialed physiotherapists who will follow the treatment principles described in McKenzie’s text book[18]. All therapists will have completed the four basic courses taught by the McKenzie Institute International. To ensure the appropriate implementation of the McKenzie’s classification algorithm, a training session with a member of McKenzie’s educational program will be conducted prior to the commencement of the study. The treatment frequency will be at the discretion of the therapist with a maximum of 7 sessions over 3 weeks. We chose to restrict the McKenzie treatment to a maximum of 7 sessions based on the study of Werneke and colleagues[39], which concluded that further reductions in pain and function are not expected if favourable changes in pain location are not present until the seventh treatment visit. Treatment procedures from the McKenzie Method are summarised in the Appendix.
Participants randomised to the control group will continue their GP care as usual. All participants regardless of intervention group will be advised not to seek other treatments for their low back pain during the treatment period. Physiotherapists will be asked to withhold co-interventions during the course of the trial.
Several mechanisms will be used to ensure that the trial protocol is applied consistently. Protocol manuals will be developed and all involved researchers (GPs, physiotherapists, assessor, and statistician) will be trained to ensure that screening, assessment, random allocation and treatment procedures are conducted according to the protocol. A random sample of treatment sessions will be audited to check that treatment is being administered according to the protocol.
Data Analysis
Power was calculated based on the primary outcome measures (pain intensity and global perceived effect). A sample size of 148 participants will provide 80% power to detect a difference of 1 unit (15%) on a 0�10 pain scale (SD = 2.0) between the experimental and control groups, assuming alpha of 0.05. This allows for loss to follow-up of 15%. This sample size also allows the detection of a difference of 1.2 units (12%) on a 0�10 global perceived effect scale (SD = 2.4).
Data will be analysed by a research member blinded to group status. The primary analysis will be by intention-to-treat. In order to estimate treatment effects, between-group mean differences (95%CI) will be calculated for all outcome measures. In the primary analysis these will be calculated using linear models that include baseline values of outcome variables as covariates to maximise precision.
Discussion
We have presented the rationale and design of an RCT evaluating the effects of the McKenzie Method in the treatment of acute non-specific LBP. The results of this trial will be presented as soon as they are available.
Competing Interests
The author(s) declare that they have no competing interests.
Authors’ Contributions
LACM, CGM and RDH were responsible for the design of the study. HC was responsible for recruiting McKenzie therapists and she will also participate as a clinician in the trial. LACM and JMc will act as trial coordinators. All authors have read and approved the final manuscript.
Appendix
Clinical picture and treatment principles according to the McKenzie Method
This table summarises the procedures involved in the McKenzie Method (Table 1). For detailed description of all procedures and progressions, refer to McKenzie’s text book. This is particularly important for Derangement syndrome since the treatment is extremely variable and complex and the full description of procedures would not be appropriate for the purposes of this paper.
The authors thank the physiotherapists credentialed in the McKenzie Method for their participation in this project.
Managing Low Back Pain: Attitudes & Treatment Preferences of Physical Therapists & Chiropractors
Abstract
Background and Purpose:�Researchers surveyed physical therapists about their attitudes, beliefs, and treatment preferences in caring for patients with different types of low back pain problems.
Subjects and Methods: Questionnaires were mailed to all 71 therapists employed by a large health maintenance organization in western Washington and to a random sample of 331 other therapists licensed in the state of Washington.
Results: Responses were received from 293 (74%) of the therapists surveyed, and 186 of these claimed to be practicing in settings in which they treat patients who have back pain. Back pain was estimated to account for 45% of patient visits. The McKenzie method was deemed the most useful approach for managing patients with back pain, and education in body mechanics, stretching, strengthening exercises, and aerobic exercises were among the most common treatment preferences. There were significant variations among therapists in private practice, hospital-operated, and health maintenance organization settings with respect to treatment preferences, willingness to take advantage of the placebo effect, and mean number of visits for patients with back pain.
Conclusions and Discussion: These variations emphasize the need for more outcomes research to identify the most effective treatment approaches and to guide clinical practice.
In conclusion,�the effective treatment of acute low back pain is essential because it can potentially help prevent the development of chronic low back pain. A growing number of chiropractors and physical therapists, including other healthcare professionals, have utilized the McKenzie method to help manage acute non-specific low back pain in patients. According to the research study, further evidence is required to support the use of the McKenzie method for LBP, however, the outcome measures of the research study regarding the effectiveness of the McKenzie method for low back pain are promising. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
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Shin Splint: Whether you are an avid exerciser, an exuberant shopper, or a small child chaser, you have probably felt tightening and burning in your shin at one point in your life. Sometimes, the pain stops when the activity ceases, but other times the pain remains. If shin pain continues bothering you, it may be time to face the fact you have shin splints.
The shin is a bone located in the front part of your lower leg. Shin splints commonly occur in athletes who have intensified or changed their training routines. They also show up in regular people who have changed or added activity to their routine.
The shin has a lot of responsibility during exercise, as it absorbs the shock of the steps, raises the toes, and support the arch of the foot.
A few main culprits play a part in shin splints:
failing to stretch properly before exercising
walking or running on hard surfaces, like pavement
wearing the wrong type of shoes during activity
over-exerting the body with strenuous activity
skipping periods of rest between exercise
Individuals who perform any type of exercise should take appropriate measures to alleviate the above risk factors of shin splints. If you notice pain and soreness in the front part of your lower leg, know how to treat this injury properly.
If rest and ice aren�t doing the job and you’re still suffering pain, it’s time to see a doctor. A thorough exam and possibly an x-ray will diagnose the problem.
Chiropractic care is a powerful choice for treating shin splints and reducing their recurrence.
Chiropractic Treatment Benefits Those Suffering From Shin Splint/s:
Reduction In Pain
Chiropractic is proven to relieve the pain associated with bodily injuries and medical conditions, including shin splints. Sometimes one visit is enough to relieve the pain, other times the pain decreases over a series of appointments. Being able to diminish a high degree of pain down to a manageable level is possible for shin splint patients through chiropractic.
Full Body Alignment
The premise behind chiropractic is that it treats the body as a whole, and, in doing so, promotes healing and health to the injured or diseased areas. A chiropractor may work on your neck to help your calf. With shin splints, he or she may align your spine and joints to lessen the impact of activity on your shins. Again, the entire body is treated in order to create the best environment for health restoration.
Healing Through Adjustments
Treating shin splints is a common procedure for chiropractors. Common practice is to adjust the calf, ankle, and foot to stretch and increase blood flow to the area.
Drug Free Treatment Option
A primary benefit of chiropractic care is it requires no over-the-counter or prescription drugs. Individuals who suffer from stomach issues, or simply prefer to avoid drugs, find chiropractic visits a productive alternative to manage pain and promote healing.
It’s routine for chiropractic treatment of shin splints to include a series of stretching and strengthening exercises the individual performs at home between visits. These exercises further expand on the positive effects of the chiropractic therapy.
If you are one of the many people dealing with shin splints, don’t despair! Consider chiropractic care as your main treatment option or in conjunction with other modes of treatment. Within a few visits, you will experience pain reduction, and enjoy a decreased risk of ever dealing with painful shin splints again.
Based on statistical findings, approximately more than three million people in the United States are injured in an automobile accident every year. In fact, auto accidents are considered to be one of the most common causes for trauma or injury. Neck injuries, such as whiplash, frequently occur due to the sudden back-and-forth movement of the head and neck from the force of the impact. The same mechanism of injury can also cause soft tissue injuries in other parts of the body, including the lower back as well as the lower extremities. Neck, hip, thigh and knee injuries are common types of injuries resulting from auto accidents.
Abstract
Objective: The purpose of this systematic review was to determine the effectiveness of exercise for the management of soft tissue injuries of the hip, thigh, and knee.
Methods: We conducted a systematic review and searched MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials, and CINAHL Plus with Full Text from January 1, 1990, to April 8, 2015, for randomized controlled trials (RCTs), cohort studies, and case-control studies evaluating the effect of exercise on pain intensity, self-rated recovery, functional recovery, health-related quality of life, psychological outcomes, and adverse events. Random pairs of independent reviewers screened titles and abstracts and assessed risk of bias using the Scottish Intercollegiate Guidelines Network criteria. Best evidence synthesis methodology was used.
Results: We screened 9494 citations. Eight RCTs were critically appraised, and 3 had low risk of bias and were included in our synthesis. One RCT found statistically significant improvements in pain and function favoring clinicbased progressive combined exercises over a �wait and see� approach for patellofemoral pain syndrome. A second RCT suggests that supervised closed kinetic chain exercises may lead to greater symptom improvement than open chain exercises for patellofemoral pain syndrome. One RCT suggests that clinic-based group exercises may be more effective than multimodal physiotherapy in male athletes with persistent groin pain.
Conclusion: We found limited high-quality evidence to support the use of exercise for the management of soft tissue injuries of the lower extremity. The evidence suggests that clinic-based exercise programs may benefit patients with patellofemoral pain syndrome and persistent groin pain. Further high-quality research is needed. (J Manipulative Physiol Ther 2016;39:110-120.e1)
Soft tissue injuries of the lower limb are common. In the United States, 36% of all injuries presenting to emergency departments are sprains and/or strains of the lower extremity. Among Ontario workers, approximately 19% of all approved lost time compensation claims are related to lower extremity injuries. Moreover, 27.5% of Saskatchewan adults injured in a traffic collision report pain in the lower extremity. Soft tissue injuries of the hip, thigh, and knee are costly and place a significant economic and disability burden on workplaces and compensation systems. According to the US Department of Labor Bureau of Statistics, the median time off work for lower extremity injuries was 12 days in 2013. Knee injuries were associated with the longest work absenteeism (median, 16 days).
Most soft tissue injuries of the lower limb are managed conservatively, and exercise is commonly used to treat these injuries. Exercise aims to promote good physical health and restore normal function of the joints and surrounding soft tissues through concepts which include range of motion, stretching, strengthening, endurance, agility, and proprioceptive exercises. However, the evidence about the effectiveness of exercise for managing soft tissue injuries of the lower limb is unclear.
Previous systematic reviews have investigated the effectiveness of exercise for the management of soft tissue injuries of the lower extremity. Reviews suggest that exercise is effective for the management of patellofemoral pain syndrome and groin injuries but not for patellar tendinopathy. To our knowledge, the only review reporting on the effectiveness of exercise for acute hamstring injuries found little evidence to support stretching, agility, and trunk stability exercises.
The purpose of our systematic review was to investigate the effectiveness of exercise compared to other interventions, placebo/sham interventions, or no intervention in improving self-rated recovery, functional recovery (eg, return to activities, work, or school), or clinical outcomes (eg, pain, health-related quality of life, depression) of patients with soft tissue injuries of the hip, thigh, and knee.
Methods
Registration
This systematic review protocol was registered with the International Prospective Register of Systematic Reviews on March 28, 2014 (CRD42014009140).
Eligibility Criteria
Population. Our review targeted studies of adults (?18 years) and/or children with soft tissue injuries of the hip, thigh, or knee. Soft tissue injuries include but are not limited to grade I to II sprains/strains; tendonitis; tendinopathy; tendinosis; patellofemoral pain (syndrome); iliotibial band syndrome; nonspecific hip, thigh, or knee pain (excluding major pathology); and other soft tissue injuries as informed by available evidence. We defined the grades of sprains and strains according to the classification proposed by the American Academy of Orthopaedic Surgeons (Tables 1 and 2). Affected soft tissues in the hip include the supporting ligaments and muscles crossing the hip joint into the thigh (including the hamstrings, quadriceps, and adductor muscle groups). Soft tissues of the knee include the supporting intra-articular and extra-articular ligaments and muscles crossing the knee joint from the thigh including the patellar tendon. We excluded studies of grade III sprains or strains, acetabular labral tears, meniscal tears, osteoarthritis, fractures, dislocations, and systemic diseases (eg, infection, neoplasm, inflammatory disorders).
Interventions. We restricted our review to studies that tested the isolated effect of exercise (ie, not part of a multimodal program of care). We defined exercise as any series of movements aimed at training or developing the body by routine practice or as physical training to promote good physical health.
Comparison Groups. We included studies that compared 1 or more exercise interventions to one another or one exercise intervention to other interventions, wait list, placebo/sham interventions, or no intervention.
Outcomes. To be eligible, studies had to include one of the following outcomes: (1) self-rated recovery; (2) functional recovery (eg, disability, return to activities, work, school, or sport); (3) pain intensity; (4) health-related quality of life; (5) psychological outcomes such as depression or fear; and (6) adverse events.
Study Characteristics. Eligible studies met the following criteria: (1) English language; (2) studies published between January 1, 1990, and April 8, 2015; (3) randomized controlled trials (RCTs), cohort studies, or case-control studies which are designed to assess the effectiveness and safety of interventions; and (4) included an inception cohort of a minimum of 30 participants per treatment arm with the specified condition for RCTs or 100 participants per group with the specified condition in cohort studies or case-control studies. Studies including other grades of sprains or strains in the hip, thigh, or knee had to provide separate results for participants with grades I or II sprains/strains to be included.
We excluded studies with the following characteristics: (1) letters, editorials, commentaries, unpublished manuscripts, dissertations, government reports, books and book chapters, conference proceedings, meeting abstracts, lectures and addresses, consensus development statements, or guideline statements; (2) study designs including pilot studies, cross-sectional studies, case reports, case series, qualitative studies, narrative reviews, systematic reviews (with or without meta-analyses), clinical practice guidelines, biomechanical studies, laboratory studies, and studies not reporting on methodology; (3) cadaveric or animal studies; and (4) studies on patients with severe injuries (eg, grade III sprains/strains, fractures, dislocations, full ruptures, infections, malignancy, osteoarthritis, and systemic disease).
Information Sources
We developed our search strategy with a health sciences librarian (Appendix 1). The Peer Review of Electronic Search Strategies (PRESS) Checklist was used by a second librarian to review the search strategy for completeness and accuracy. We searched MEDLINE and EMBASE, considered to be the major biomedical databases, and PsycINFO, for psychological literature through Ovid Technologies, Inc; CINAHL Plus with Full Text for nursing and allied health literature through EBSCOhost; and the Cochrane Central Register of Controlled Trials through Ovid Technologies, Inc, for any studies not captured by the other databases. The search strategy was first developed in MEDLINE and subsequently adapted to the other bibliographic databases. Our search strategies combined controlled vocabulary relevant to each database (eg, MeSH for MEDLINE) and text words relevant to exercise and soft tissue injuries of the hip, thigh, or knee including grade I to II sprain or strain injuries (Appendix 1). We also hand searched the reference lists of previous systematic reviews for any additional relevant studies.
Study Selection
A 2-phase screening process was used to select eligible studies. Random pairs of independent reviewers screened citation titles and abstracts to determine the eligibility of studies in phase 1. Screening resulted in studies being classified as relevant, possibly relevant, or irrelevant. In phase 2, the same pairs of reviewers independently screened the possibly relevant studies to determine eligibility. Reviewers met to reach consensus on the eligibility of studies and resolve disagreements. A third reviewer was used if consensus could not be reached.
Assessment of Risk of Bias
Independent reviewers were randomly paired to critically appraise the internal validity of eligible studies using the Scottish Intercollegiate Guidelines Network (SIGN) criteria. The impact of selection bias, information bias, and confounding on the results of a study was qualitatively evaluated using the SIGN criteria. These criteria were used to guide reviewers in making an informed overall judgment on the internal validity of studies. This methodology has been previously described. A quantitative score or a cutoff point to determine the internal validity of studies was not used for this review.
The SIGN criteria for RCTs were used to critically appraise the following methodological aspects: (1) clarity of the research question, (2) randomization method, (3) concealment of treatment allocation, (4) blinding of treatment and outcomes, (5) similarity of baseline�characteristics between/among treatment arms, (6) cointervention contamination, (7) validity and reliability of outcome measures, (8) follow-up rates, (9) analysis according to intention-to-treat principles, and (10) comparability of results across study sites (where applicable). Consensus was reached through reviewer discussion. Disagreements were resolved by an independent third reviewer when consensus could not be reached. The risk of bias of each appraised study was also reviewed by a senior epidemiologist (PC). Authors were contacted when additional information was needed to complete the critical appraisal. Only studies with low risk of bias were included in our evidence synthesis.
Data Extraction and Synthesis of Results
Data were extracted from studies (DS) with low risk of bias to create evidence tables. A second reviewer independently checked the extracted data. We stratified results based on the duration of the condition (recent onset [0-3 months], persistent [N3 months], or variable duration [recent onset and persistent combined]).
We used standardized measures to determine the clinical importance of changes reported in each trial for common outcome measures. These include a between-group difference of 2/10 points on the Numeric Rating Scale (NRS), 2/10 cm difference on the Visual Analog Scale (VAS), and 10/100 point difference on the Kujala Patellofemoral scale, otherwise known as the Anterior Knee Pain Scale.
Statistical Analyses
Agreement between reviewers for the screening of articles was computed and reported using the ? statistic and 95% confidence interval (CI). Where available, we used data provided in the studies with a low risk of bias to measure the association between the tested interventions and the outcomes by computing the relative risk (RR) and its 95% CI. Similarly, we computed differences in mean changes between groups and 95% CI to quantify the effectiveness of interventions. The calculation of 95% CIs was based on the assumption that baseline and follow-up outcomes were highly correlated (r = 0.80).
Reporting
This systematic review was organized and reported based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.
Dr. Alex Jimenez’s Insight
As a doctor of chiropractic, automobile accident injuries are one of the most common reasons people seek chiropractic care. From neck injuries, such as whiplash, to headaches and back pain, chiropractic can be utilized to safely and effectively restore the integrity of the spine after a car crash. A chiropractor like myself will often use a combination of spinal adjustments and manual manipulations, as well as a variety of other non-invasive treatment methods,�to gently correct any spinal misalignments resulting from an auto accident injury. Whiplash and other types of neck injuries occur when the complex structures along the cervical spine are stretched beyond their natural range of movement due to the sudden back-and-forth movement of the head and neck from the force of the impact. Back injury, particularly in the lower spine, are also common as a result of an automobile accident. When the complex structures along the lumbar spine are damaged or injured, symptoms of sciatica may radiate down the lower back, into the buttocks, hips, thighs, legs and down into the feet. Knee injuries may also occur upon impact during an auto accident. Exercise is frequently used with chiropractic care to help promote recovery as well as improve strength, flexibility and mobility. Rehabilitation exercises are offered to patients to further restore the integrity of their body. The following research studies demonstrate that exercise, compared to non-invasive treatment options, is a safe and effective treatment method for individuals suffering with neck and lower extremity injury from a car crash.
Results
Study Selection
We screened 9494 citations based on the title and abstract (Figure 1). Of these, 60 full-text publications were screened, and 9 articles were critically appraised. The primary reasons for ineligibility during full text screening were (1) ineligible study design, (2) small sample size (n b 30 per treatment arm), (3) multimodal interventions not allowing isolation of the effectiveness of exercise, (4) ineligible study population, and (5) interventions not meeting our definition of exercise (Figure 1). Of those critically appraised, 3 studies (reported in 4 articles) had low risk of bias and were included in our synthesis. The interrater agreement for the screening of the articles was ? = 0.82 (95% CI, 0.69-0.95). The percentage agreement for the critical appraisal of studies was 75% (6/8 studies). Disagreement was resolved through discussion for 2 studies. We contacted authors from 5 studies during critical appraisal to request additional information and 3 responded.
Study Characteristics
The studies with low risk of bias were RCTs. One study, conducted in the Netherlands, examined the effectiveness of a standardized exercise program compared to a �wait and see� approach in participants with patellofemoral pain syndrome of variable duration. A second study, with outcomes reported in 2 articles, compared the benefit of closed vs open kinetic chain exercises in individuals with�variable duration patellofemoral pain syndrome in Belgium. The final study, conducted in Denmark, investigated active training compared to a multimodal physiotherapy intervention for the management of persistent adductor-related groin pain.
Two RCTs used exercise programs that combined strengthening exercises with balance or agility training for the lower extremity. Specifically, the strengthening exercises consisted of both isometric and concentric contractions of the quadriceps, hip adductor, and gluteal muscles for the management of patellofemoral pain46 and hip adductors and muscles of the trunk and pelvis for adductor-related groin pain. The exercise programs ranged from 646 to 1243 weeks in duration and were supervised and clinic based with additional daily home exercises. The exercise programs were compared to a �wait and see� approach or to multimodal physiotherapy. The third RCT compared 2 different 5-week protocols which combined either closed or open kinetic chain strengthening and stretching exercises for the lower extremity musculature.
Meta-analysis was not performed due to heterogeneity of accepted studies with respect to patient populations, interventions, comparators, and outcomes. Principles of best evidence synthesis were used to develop evidence statements and perform a qualitative synthesis of findings from studies with low risk of bias.
Risk of Bias Within Studies
The studies with low risk of bias had a clearly defined research question, used appropriate blinding methods where possible, reported adequate similarity of baseline characteristics between treatment arms, and performed an intention-to-treat analyses where applicable (Table 3). The RCTs had follow-up rates greater than 85%. However, these studies also had methodological limitations: insufficient detail describing methods for allocation concealment (1/3), insufficient detail describing methods of randomization (1/3), the use of outcome measures that have not been demonstrated to be valid or reliable (ie, muscle length and successful treatment) (2/3), and clinically important differences in baseline characteristics (1/3).
Of 9 relevant articles, 5 were deemed to have high risk of bias. These studies had the following limitations: (1) poor or unknown randomization methods (3/5); (2) poor or unknown allocation concealment methods (5/ 5); (3) outcome assessor not blinded (4/ 5); (4) clinically important differences in baseline characteristics (3/5); (5) dropouts not reported, insufficient information regarding dropouts per group or large differences in dropout rates between treatment arms (N15%) (3/5); and (6) a lack of information about or no intention-to-treat analysis (5/5).
Summary of Evidence
Patellofemoral Pain Syndrome of Variable Duration. Evidence from 1 RCT suggests that a clinic-based progressive exercise program may provide short- and long-term benefit over usual care for the management of patellofemoral pain syndrome of variable duration. van Linschoten et al randomized participants with a clinical diagnosis of patellofemoral pain syndrome of 2 months to 2 years duration to (1) a clinic-based exercise program (9 visits over 6 weeks) consisting of progressive, static, and dynamic strengthening exercises for the quadriceps, adductor, and gluteal muscles and balance and flexibility exercises, or (2) a usual care �wait and see� approach. Both groups received standardized information, advice, and home-based isometric exercises for the quadriceps based on recommendations from Dutch General Practitioner guidelines (Table 4). There�were statistically significant differences favoring the exercise group for (1) pain (NRS) at rest at 3 months (mean change difference 1.1/10 [95% CI, 0.2-1.9]) and 6 months (mean change difference 1.3/10 [95% CI, 0.4-2.2]); (2) pain (NRS) with activity at 3 months (mean change difference 1.0/10 [95% CI, 0.1-1.9]) and 6 months (mean change difference 1.2/10 [95% CI, 0.2-2.2]); and (3) function (Kujala Patellofemoral Scale [KPS]) at 3 months (mean change difference 4.9/100 [95% CI, 0.1-9.7]). However, none of these differences were clinically important. Furthermore, there were no significant differences in the proportion of participants reporting recovery (fully recovered, strongly recovered), but the exercise group was more likely to report improvement at 3-month follow-up (odds ratio [OR], 4.1 [95% CI, 1.9-8.9]).
Evidence from a second RCT suggests that physiotherapist- supervised closed kinetic chain leg exercises (where the foot remains in constant contact with a surface) may provide short-term benefit compared to supervised open kinetic chain exercises (where the limb moves freely) for some patellofemoral pain syndrome symptoms (Table 4). All participants trained for 30 to 45 minutes, 3 times per week for 5 weeks. Both groups were instructed to perform static lower limb stretching after each training session. Those randomized to closed chain exercises performed supervised (1) leg presses, (2) knee bends, (3) stationary biking, (4) rowing, (5) step-up and step-down exercises, and (6) progressive jumping exercises. Open chain exercise participants performed (1) maximal quad muscle contraction, (2) straight-leg raises, (3) short arc movements from 10� to full knee extension, and (4) leg adduction. Effect sizes were not reported, but the authors reported statistically significant differences favoring closed kinetic chain exercise at 3 months for (1) frequency of locking (P = .03), (2) clicking sensation (P = .04), (3) pain with isokinetic testing (P = .03), and (4) pain during night (P = .02). The clinical significance of these results is unknown. There were no statistically significant differences between groups for any other pain or functional measures at any follow-up period.
Persistent Adductor-Related Groin Pain
Evidence from 1 RCT suggests that a clinic-based group exercise program is more effective than a multimodal program of care for persistent adductor-related groin pain. H�lmich et al studied a group of male athletes with a clinical diagnosis of adductor-related groin pain of greater than 2 months duration (median duration, 38-41 weeks; range, 14-572 weeks) with or without osteitis pubis. Participants were randomized to (1) a clinic-based group exercise program (3 sessions per week for 8-12 weeks) consisting of isometric and concentric resistance strengthening exercises for the adductors, trunk, and pelvis; balance and agility exercises for the lower extremity; and stretching for the abdominals, back, and lower extremity (with the exception of the adductor muscles) or (2) a multimodal physiotherapy program (2 visits per week for 8-12 weeks) consisting of laser; transverse friction massage; transcutaneous electrical nerve stimulation (TENS); and stretching for the adductors, hamstrings, and hip flexors (Table 4). Four months after the intervention, the exercise group was more likely to report that their condition was �much better� (RR, 1.7 [95% CI, 1.0-2.8]).
Adverse Events
None of the included studies commented on the frequency or nature of adverse events.
Discussion
Summary of Evidence
Our systematic review examined the effectiveness of exercise for the management of soft tissue injuries of the hip, thigh, or knee. Evidence from 1 RCT suggests that a clinic-based progressive combined exercise program may offer additional short- or long-term benefit compared to providing information and advice for the management of patellofemoral pain syndrome of variable duration. There is also evidence that supervised closed kinetic chain exercises may be beneficial for some patellofemoral pain syndrome symptoms compared to open kinetic chain exercises. For persistent adductor-related groin pain, evidence from 1 RCT suggests that a clinic-based group exercise program is more effective than a multimodal program of care. Despite the common and frequent use of exercise prescription, there is limited high-quality evidence to inform the use of exercise for the management of soft tissue injuries of the lower extremity. Specifically, we did not find high-quality studies on exercise for the management of some of the more commonly diagnosed conditions including patellar tendinopathy, hamstring sprain and strain injuries, hamstring tendinopathy, trochanteric bursitis, or capsular injuries of the hip.
Previous Systematic Reviews
Our results are consistent with findings from previous systematic reviews, concluding that exercise is effective for the management of patellofemoral pain syndrome and groin pain. However, the results from previous systematic reviews examining the use of exercise for the management of patellar tendinopathy and acute hamstring injuries are inconclusive. One review noted strong evidence for use of eccentric training, whereas others reported uncertainty of whether isolated eccentric exercises were beneficial for tendinopathy compared to other forms of exercise. Furthermore, there is limited evidence of a positive effect from stretching, agility and trunk stability exercises, or slump stretching for the management of acute�hamstring injuries. Differing conclusions between systematic reviews and the limited number of studies deemed admissible in our work may be attributed to differences in methodology. We screened reference lists of previous systematic reviews, and most studies included in the reviews did not meet our inclusion criteria. Many studies accepted in other reviews had small sample sizes (b30 per treatment arm). This increases the risk of residual confounding while also reducing the effect size precision. Furthermore, a number of systematic reviews included case series and case studies. These types of studies are not designed to assess the effectiveness of interventions. Finally, previous reviews included studies where exercise was part of a multimodal intervention, and as a consequence, the isolated effect of exercise could not be ascertained. Of the studies that satisfied our selection criteria, all were critically appraised in our review, and only 3 had low risk of bias and were included in our synthesis.
Strengths
Our review has many strengths. First, we developed a rigorous search strategy that was independently reviewed by a second librarian. Second, we defined clear inclusion and exclusion criteria for the selection of possibly relevant studies and only considered studies with adequate sample sizes. Third, pairs of trained reviewers screened and critically appraised eligible studies. Fourth, we used a valid set of criteria (SIGN) to critically appraise studies. Finally, we restricted our synthesis to studies with low risk of bias.
Limitations and Recommendations for Future Research
Our review also has limitations. First, our search was limited to studies published in the English language. However, previous reviews have found that the restriction of systematic reviews to English language studies has not led to a bias in reported results. Second, despite our broad definition of soft tissue injuries of the hip, thigh, or knee, our search strategy may not have captured all potentially relevant studies. Third, our review may have missed potentially relevant studies published before 1990. We aimed to minimize this by hand searching the reference lists of previous systematic reviews. Finally, critical appraisal requires scientific judgment that may differ between reviewers. We minimized this potential bias by training reviewers in the use of the SIGN tool and using a consensus process to determine study admissibility. Overall, our systematic review highlights a deficit of strong research in this area.
High-quality studies on the effectiveness of exercise for the management of soft tissue injuries of the lower extremity are needed. Most studies included in our review (63%) had a high risk of bias and could not be included in our synthesis. Our review identified important gaps in the literature. Specifically, studies are needed to inform the specific effects of exercises, their long-term effects, and the optimal doses of intervention. Furthermore, studies are needed to determine the relative effectiveness of different types of exercise programs and if the effectiveness varies for soft tissue injuries of the hip, thigh, and knee.
Conclusion
There is limited high-quality evidence to inform the use of exercise for the management of soft tissue injuries of the hip, thigh, and knee. The current evidence suggests that a clinic-based progressive combined exercise program may lead to improved recovery when added to information and advice on resting and avoiding pain provoking activities for the management of patellofemoral pain syndrome. For persistent adductor-related groin pain, a supervised clinic- based group exercise program is more effective than multimodal care in promoting recovery.
Funding Sources and Potential Conflicts of Interest
This study was funded by the Ontario Ministry of Finance and the Financial Services Commission of Ontario (RFP no. OSS_00267175). The funding agency was not involved in the collection of data, data analysis, interpretation of data, or drafting of the manuscript. The research was undertaken, in part, thanks to funding from the Canada Research Chairs program. Pierre C�t� has previously received funding from a Grant from the Ontario Ministry of Finance; consulting for the Canadian Chiropractic Protective Association; speaking and/or teaching arrangements for the National Judicial Institute and Soci�t� des M�decins Experts du Quebec; trips/travel, European Spine Society; board of directors, European Spine Society; grants: Aviva Canada; fellowship support, Canada Research Chair Program�Canadian Institutes of Health Research. No other conflicts of interest were reported for this study.
Contributorship Information
Concept development (provided idea for the research): D.S., C.B., P.C., J.W., H.Y., S.V.
Design (planned the methods to generate the results): D.S., C.B., P.C., H.S., J.W., H.Y., S.V.
Supervision (provided oversight, responsible for organization and implementation, writing of the manuscript): D.S., P.C.
Data collection/processing (responsible for experiments, patient management, organization, or reporting data): D.S., C.B., H.S., J.W., D.e.S., R.G., H.Y., K.R., J.C., K.D., P.C., P.S., R.M., S.D., S.V.
Analysis/interpretation (responsible for statistical analysis, evaluation, and presentation of the results): D.S., C.B., P.C., H.S., M.S., K.R., L.C.
Literature search (performed the literature search): A.T.V.
Writing (responsible for writing a substantive part of the manuscript): D.S., C.B., P.C., H.S.
Critical review (revised manuscript for intellectual content, this does not relate to spelling and grammar checking): D.S., P.C., H.S., J.W., D.e.S., R.G., M.S., A.T.V., H.Y., K.R., J.C., K.D., L.C., P.S., S.D., R.M., S.V.
Practical Applications
There is evidence to suggest that clinic-based exercises may benefit patients with patellofemoral pain syndrome or adductor-related groin pain.
Supervised progressive exercises may be beneficial for patellofemoral pain syndrome of variable duration compared to information/advice.
Supervised closed kinetic chain exercises may provide more benefit compared to open kinetic chain exercises for some patellofemoral pain syndrome symptoms.
Self-rated improvement in persistent groin pain is higher after a clinic-based group exercise program compared to multimodal physiotherapy.
Are Non-Invasive Interventions Effective for the Management of Headaches Associated with Neck Pain?
Furthermore,�other non-invasive interventions, as well as non-pharmacological interventions, are also commonly utilized to help treat symptoms of neck pain and headaches associated with neck injuries, such as whiplash, caused by automobile accidents. As mentioned before, whiplash is one of the most common types of neck injuries resulting from auto accidents. Chiropractic care, physical therapy and exercise, can be used to improve the symptoms of neck pain, according to the following research studies.
Abstract
Purpose
To update findings of the 2000�2010 Bone and Joint Decade Task Force on Neck Pain and its Associated Disorders and evaluate the effectiveness of non-invasive and non-pharmacological interventions for the management of patients with headaches associated with neck pain (i.e., tension-type, cervicogenic, or whiplash-related headaches).
Methods
We searched five databases from 1990 to 2015 for randomized controlled trials (RCTs), cohort studies, and case�control studies comparing non-invasive interventions with other interventions, placebo/sham, or no interventions. Random pairs of independent reviewers critically appraised eligible studies using the Scottish Intercollegiate Guidelines Network criteria to determine scientific admissibility. Studies with a low risk of bias were synthesized following best evidence synthesis principles.
Results
We screened 17,236 citations, 15 studies were relevant, and 10 had a low risk of bias. The evidence suggests that episodic tension-type headaches should be managed with low load endurance craniocervical and cervicoscapular exercises. Patients with chronic tension-type headaches may also benefit from low load endurance craniocervical and cervicoscapular exercises; relaxation training with stress coping therapy; or multimodal care that includes spinal mobilization, craniocervical exercises, and postural correction. For cervicogenic headaches, low load endurance craniocervical and cervicoscapular exercises; or manual therapy (manipulation with or without mobilization) to the cervical and thoracic spine may also be helpful.
Conclusions
The management of headaches associated with neck pain should include exercise. Patients who suffer from chronic tension-type headaches may also benefit from relaxation training with stress coping therapy or multimodal care. Patients with cervicogenic headache may also benefit from a course of manual therapy.
We would like to acknowledge and thank all of the individuals who have made important contributions to this review: Robert Brison, Poonam Cardoso, J. David Cassidy, Laura Chang, Douglas Gross, Murray Krahn, Michel Lacerte, Gail Lindsay, Patrick Loisel, Mike Paulden, Roger Salhany, John Stapleton, Angela Verven, and Leslie Verville. We would also like to thank Trish Johns-Wilson at the University of Ontario Institute of Technology for her review of the search strategy.
Compliance with Ethical Standards
Conflict of Interest
Dr. Pierre C�t� has received a grant from the Ontario government, Ministry of Finance, funding from the Canada Research Chairs program, personal fees from National Judicial Institute for lecturing, and personal fees from European Spine Society for teaching. Drs. Silvano Mior and Margareta Nordin have received reimbursement for travel expenses to attend meetings for the study. The remaining authors report no declarations of interest.
Funding
This work was supported by the Ontario Ministry of Finance and the Financial Services Commission of Ontario [RFP# OSS_00267175]. The funding agency had no involvement in the study design, collection, analysis, interpretation of data, writing of the manuscript or decision to submit the manuscript for publication. The research was undertaken, in part, thanks to funding from the Canada Research Chairs program to Dr. Pierre C�t�, Canada Research Chair in Disability Prevention and Rehabilitation at the University of Ontario Institute of Technology.
In conclusion,�exercise included in chiropractic care and other non-invasive interventions should be utilized as an essential part of treatment to further help improve the symptoms of neck injury as well as that of hip, thigh and knee injury. According to the above research studies, exercise, or physical activity, is beneficial towards speeding up recovery time for patients with automobile accident injuries and for restoring strength, flexibility and mobility to the affected structures of the spine. Information referenced from the National Center for Biotechnology Information (NCBI). The scope of our information is limited to chiropractic as well as to spinal injuries and conditions. To discuss the subject matter, please feel free to ask Dr. Jimenez or contact us at 915-850-0900 .
Curated by Dr. Alex Jimenez
Additional Topics: Sciatica
Sciatica is referred to as a collection of symptoms rather than a single type of injury or condition. The symptoms are characterized as radiating pain, numbness and tingling sensations from the sciatic nerve in the lower back, down the buttocks and thighs and through one or both legs and into the feet. Sciatica is commonly the result of irritation, inflammation or compression of the largest nerve in the human body, generally due to a herniated disc or bone spur.
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Chiropractic Care: Our neck is a busy body part. It holds up and turns our head, allowing us to see, hear, and speak in the direction we choose.
Although the neck is a real “team player” it’s a bit of a diva, meaning it’s fairly delicate. There are many ways everyday motion injures the neck, ending up causing pain, decreased mobility, and varying degrees of short and long-term misery.
Whiplash is a common neck injury caused by a sudden movement that jerks the neck forth and then back in a whipping motion. Automobile accidents frequently result in whiplash, as the vehicle is moving and then stopping rapidly.
This affects the neck’s ligaments and joints in various degrees, depending on the speed of the vehicle and the site of the impact. In severe cases, the discs and the nerves may also be damaged.
Symptoms of whiplash include varying degrees of pain, stiffness in the neck, headaches, and sometimes dizziness, blurred vision, and nausea. Some people only suffer with whiplash a few days, while others experience ongoing issues.
If you have been injured in an automobile crash, it’s in your best interest to immediately schedule an appointment with a chiropractor. There are a myriad of ways chiropractic care assists in managing the pain and minimizing the symptoms of whiplash.
Here Are The 5 Best Reasons For Chiropractic Care:
#1: Reduces Inflammation To Promote Healing
The first order of business for whiplash sufferers is to get the neck’s inflammation reduced, as this hinders proper healing. Your chiropractor will utilize chiropractic adjustments, along with other forms of treatment based on your specific injury. It�s essential to undergo this type of treatment as soon after the injury occurs as possible in order to reach optimum results.
#2: Minimizes Pain For Greater Comfort
Whiplash can be extremely painful, as so many of the neck’s components may be involved, and the neck is such a mobile body part. Every neck movement hurting is no way to live! Chiropractic care soothes the pain of whiplash through therapeutic techniques that promote healing of the damaged area.
#3: Returns Proper Body Alignment
When the inflammation and the pain of whiplash are reduced, the next step is to promote healing and alignment within the body. A chiropractor will perform a series of chiropractic adjustments that includes the neck and spine, but may also incorporate other parts of the body. Whiplash does a number on the body’s natural alignment, and it’s the chiropractor’s job to put it all back together in workable order.
#4: Offers Exercises To Increase Mobility
Contrary to old movies where the whiplash sufferer wears a cumbersome neck brace, it’s vital to the rehabilitation process to keep moving. During chiropractic visits, patients receive a regimen of exercises to perform regularly at home. These, combined with chiropractic care, lessen the time it takes to recover.
#5: Provides An Alternative To Surgery
The good news is that a whiplash injury rarely requires surgery. However, it’s best to not tempt fate and visit a chiropractor to make certain your injuries are treated and begin healing. A chiropractor monitors improvements and keeps you apprised of your progress, empowering you to get better and back to normal activity faster than simply suffering through the symptoms, hoping they go away.
If you are involved in a motor vehicle crash and end up with whiplash, don’t despair. A chiropractor will map out a treatment regimen that will decrease inflammation and pain, increase mobility, and promote healing. Remember, the sooner you see your chiropractor, the faster the treatment begins, and the sooner you see results. Don’t suffer needlessly!
Chiropractic Care & Headaches
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#1: Reduces Inflammation To Promote Healing
