Gender differences in PTSD severity and pain outcomes: baseline results from the LAMP trial.

Background: Post-traumatic stress disorder (PTSD) and chronic pain are highly prevalent comorbid conditions. Veterans dually burdened by PTSD and chronic pain experience more severe outcomes compared to either disorder alone. Few studies have enrolled enough women Veterans to test gender differences in pain outcomes [catastrophizing, intensity, interference] by the severity of PTSD. Aim: Examine gender differences in the association between PTSD symptoms and pain outcomes among Veterans enrolled in a chronic pain clinical trial. Methods: Participants were 421 men and 386 women Veterans with chronic pain who provided complete data on PTSD symptoms and pain outcomes. We used hierarchical linear regression models to examine gender differences in pain outcomes by PTSD symptoms. Results: Adjusted multivariable models indicated that PTSD symptoms were associated with higher levels of pain catastrophizing (0.57, 95% CI [0.51, 0.63]), pain intensity (0.30, 95% CI [0.24, 0.37]), and pain interference (0.46, 95% CI [0.39, 0.52]). No evidence suggesting differences in this association were found in either the crude or adjusted models (all interaction p-values<0.05). Conclusion: These findings may reflect the underlying mutual maintenance of these conditions whereby the sensation of pain could trigger PTSD symptoms, particularly if the trauma and pain are associated with the same event. Clinical implications and opportunities testing relevant treatments that may benefit both chronic pain and PTSD are discussed.

Exercises for mechanical neck disorders: A Cochrane review update.

BACKGROUND: Neck pain (NP) is disabling and costly. OBJECTIVES: To assess the effectiveness of exercise on pain, disability, function, patient satisfaction, quality of life (QoL) and global perceived effect (GPE) in adults with NP. METHODS: We searched computerised databases up to May 2014 for randomized controlled trials (RCTs) comparing exercise to a control in adults with NP with/without cervicogenic headache (CGH) or radiculopathy. Two reviewers independently conducted selection, data abstraction and assessed risk of bias. Meta-analyses were performed to establish pooled standardised mean differences (SMDp). The Grade of Recommendation, Assessment, Development and Evaluation (GRADE) was used to summarise the body of evidence. MAIN RESULTS: The following exercises (27 trials) were supported by 'Moderate GRADE' evidence: For chronic NP, 1) cervico-scapulothoracic and upper extremity (UE) strengthening for moderate to large pain reduction immediately post treatment (IP) and at short-term (ST) follow-up; 2) scapulothoracic and UE endurance training for a small pain reduction (IP/ST); 3) cervical, shoulder and scapulothoracic strengthening and stretching exercise for a small to large pain reduction in the long-term (LT) (SMDp -0.45 [95%CI: -0.72 to -0.18]) and function improvement; 4) cervico-scapulothoracic strengthening/stabilisation exercises for pain and function at intermediate-term (IT) (SMDp -14.90 [95%CI: -22.40 to -7.39]). 5) mindfulness exercises (Qigong) for minor improved function but not GPE (ST). For chronic CGH, cervico-scapulothoracic strengthening and endurance exercises including pressure biofeedback for small/moderate improvement of pain, function and GPE (IP/LT). AUTHORS' CONCLUSIONS: Specific strengthening exercises of the neck, scapulothoracic and shoulder for chronic NP and chronic CGH are beneficial. Future research should explore optimal dosage.

Traction for low-back pain with or without sciatica.

BACKGROUND: Traction is used to treat low-back pain (LBP), often with other treatments. OBJECTIVES: To determine traction's effectiveness, compared to reference treatments, placebo, sham traction or no treatment for LBP. SEARCH STRATEGY: We searched CENTRAL (The Cochrane Library 2006, issue 4), MEDLINE, EMBASE, and CINAHL to October 2006, references in relevant reviews and personal files. SELECTION CRITERIA: Randomized controlled trials (RCTs) involving traction to treat acute (less than four weeks duration), sub-acute (four to 12 weeks) or chronic (more than 12 weeks) non-specific LBP with or without sciatica. DATA COLLECTION AND ANALYSIS: Study selection, methodological quality assessment and data extraction were done independently by two authors. As there were insufficient data for statistical pooling, we performed a qualitative analysis. MAIN RESULTS: We included 25 RCTs (2206 patients; 1045 receiving traction). Five trials were considered high quality. For patients with mixed symptom patterns (acute, sub-acute and chronic LBP with and without sciatica) there is: strong evidence of no statistically significant difference in outcomes between traction as a single treatment and placebo, sham or no treatment; moderate evidence that traction as a single treatment is no more effective than other treatments; limited evidence of no significant difference in outcomes between a standard physical therapy program with or without continuous traction. For LBP patients with sciatica (with acute, sub-acute or chronic pain), there is conflicting evidence in several comparisons: autotraction compared to placebo, sham or no treatment; other forms of traction compared to other treatments; different forms of traction. In other comparisons, there were no statistically significant differences; the evidence is moderate for continuous or intermittent traction compared to placebo, sham or no treatment, and limited for light versus normal force traction. IMPLICATIONS FOR PRACTICE: The results of the available studies involving mixed groups of acute, sub-acute and chronic patients with LBP with and without sciatica were quite consistent, indicating that continuous or intermittent traction as a single treatment for LBP is not likely effective for this group. Traction for patients with sciatica cannot be judged effective at present either, due to inconsistent results and methodological problems in most studies. We conclude that traction as a single treatment for LBP is probably not effective. IMPLICATIONS FOR RESEARCH: Any future research on traction for patients with LBP should distinguish between symptom pattern and duration, and should be carried out according to the highest methodological standards.

Massage for mechanical neck disorders.

BACKGROUND: Mechanical neck disorders (MND) are common, disabling and costly. Massage is a commonly used modality for the treatment of neck pain. OBJECTIVES: To assess the effects of massage on pain, function, patient satisfaction and cost of care in adults with neck pain. To document adverse effects of treatment. SEARCH STRATEGY: Cochrane CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL databases were electronically searched, without language restriction, from their inception to September 2004 SELECTION CRITERIA: Studies using random or quasi-random assignment were included. DATA COLLECTION AND ANALYSIS: Two reviewers independently conducted citation identification, study selection, data abstraction and methodological quality assessment. Using a random-effects model, we calculated the relative risk and standardized mean difference. MAIN RESULTS: Nineteen trials met the inclusion criteria. Overall, the methodological quality was low, with 12/19 assessed as low-quality studies. Trials could not be statistically pooled because of heterogeneity in treatment and control groups. Therefore, a levels-of-evidence approach was used to synthesize results. Assessment of the clinical applicability of the trials showed that the participant characteristics were well reported, but neither the descriptions of the massage intervention nor the credentials or experience of the massage professionals were well reported. Six trials examined massage as a stand-alone treatment. The results were inconsistent. Of the 14 trials that used massage as part of a multimodal intervention, none were designed such that the relative contribution of massage could be ascertained. Therefore, the role of massage in multimodal treatments remains unclear. AUTHORS' CONCLUSIONS: No recommendations for practice can be made at this time because the effectiveness of massage for neck pain remains uncertain. Pilot studies are needed to characterize massage treatment (frequency, duration, number of sessions, and massage technique) and establish the optimal treatment to be used in subsequent larger trials that examine the effect of massage as either a stand-alone treatment or part of a multimodal intervention. For multimodal interventions, factorial designs are needed to determine the relative contribution of massage. Future reports of trials should improve reporting of the concealment of allocation, blinding of outcome assessor, adverse events and massage characteristics. Standards of reporting for massage interventions, similar to CONSORT, are needed. Both short- and long-term follow-up are needed.

Traction for low-back pain with or without sciatica.

BACKGROUND: Various types of traction are used in the treatment of low-back pain (LBP), often in conjunction with other treatments. OBJECTIVES: To determine the effectiveness of traction in the management of LBP. SEARCH STRATEGY: We searched The Cochrane Library 2004, Issue 4, MEDLINE, EMBASE, and CINAHL to November 2004, references in relevant reviews, and our personal files. SELECTION CRITERIA: Randomized controlled trials (RCTs) examining any type of traction for the treatment of acute (less than four weeks duration), sub-acute (four to 12 weeks) or chronic (more than 12 weeks) non-specific LBP with or without sciatica. DATA COLLECTION AND ANALYSIS: Study selection, methodological quality assessment and data extraction were done independently by sets of two reviewers. As available studies did not provide sufficient data for statistical pooling, a qualitative analysis was performed. MAIN RESULTS: Twenty-four RCTs, involving 2177 patients (1016 receiving traction) were included in the review. Five trials were considered high quality. There is strong evidence that there is no significant difference in short or long-term outcomes between either continuous or intermittent traction and placebo, sham, or other treatments for patients with a mixed duration of LBP, with or without sciatica. There is moderate evidence that: autotraction is more effective other forms of traction are no more effective than placebo, sham or no treatment for patients with a mixed duration of LBP with sciatica. There is limited evidence that: there is no significant difference in outcomes between a standard physical therapy program with continuous traction and the same program without traction, for patients with a mixed duration of LBP, with or without sciatica autotraction on its own is more effective than a physical therapy program that includes Tru-Trac traction for patients with a mixed duration of LBP with sciatica. There is conflicting evidence regarding the short-term effectiveness of either continuous or intermittent traction compared to placebo, sham or other treatments, in the management of patients who have either chronic LBP or a mixed duration of LBP with sciatica. AUTHORS' CONCLUSIONS: The evidence suggests that traction is probably not effective. Neither continuous nor intermittent traction by itself was more effective in improving pain, disability or work absence than placebo, sham or other treatments for patients with a mixed duration of LBP, with or without sciatica. Although trials studying patients with sciatica had methodological limitations and inconsistent results, there was moderate evidence that autotraction was more effective than mechanical traction for global improvement in this population.

Exercises for mechanical neck disorders.

BACKGROUND: Neck disorders are common, limit function, and are costly to individuals and society. Exercise therapy is a commonly used treatment for neck pain. The effectiveness of exercise therapy remains unclear. OBJECTIVES: To assess the effectiveness of exercise therapy to relieve pain, or improve function, disability, patient satisfaction, and global perceived effect in adults with mechanical neck disorders (MND). SEARCH STRATEGY: Computerised bibliographic databases including CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL were searched, without language restrictions, from their beginning up to March 2004, and reference lists of articles were scanned. SELECTION CRITERIA: Selected studies were randomised [RCTs] or quasi-randomised trials and investigated the use of exercise therapy as a treatment in adults with MND with or without headache or radicular signs and symptoms. DATA COLLECTION AND ANALYSIS: Two reviewers independently conducted citation identification, study selection, data abstraction, and methodological quality assessment. Using a random effects model, relative risk and standardized mean differences were calculated. The reasonableness of combining studies was assessed on clinical and statistical grounds. In the absence of heterogeneity, pooled effect measures were calculated. When trials were considered homogenous, results were summarised using a rating system of five levels of evidence. MAIN RESULTS: Thirty-one trials were selected, 19% (van Tulder criteria) to 35% (Jadad scale) had high quality. There is limited evidence of benefit that acute range of motion (AROM) may reduce pain in acute MND (whiplash associated disorder (WAD)) in the short term. There is moderate evidence of benefit that neck strengthening exercises reduce pain, improve function and global perceived effect for chronic neck disorder with headache in the short and long term. There is unclear evidence regarding the impact of a stretching and strengthening program on pain, function and global perceived effect for MND. However, when this stretching and strengthening program focuses on the cervical or cervical and shoulder/thoracic region, there is moderate evidence of benefit on pain in chronic MND [pooled SMD -0.42 (95%CI: -0.83 to -0.01)] and neck disorder plus headache, in the short and long term. There is strong evidence of benefit favouring a multimodal care approach of exercise combined with mobilisation or manipulation for subacute and chronic MND with or without headache, in the short and long term. A program of eye fixation or proprioception exercises imbedded in a more complete program shows moderate evidence of benefit for pain [pooled SMD -0.72 (95% CI:-1.12 to -0.32)], function, and global perceived for chronic MND in the short term, and on pain and function for acute and subacute MND with headache or WAD in the long term. There is limited evidence of benefit on pain relief in the short term for a home mobilisation program with other physical modalities over a program of rest then gradual mobilisation for acute MND or WAD. There was evidence of no difference between the different exercise approaches. AUTHORS' CONCLUSIONS: The evidence summarised in this systematic review indicates that specific exercises may be effective for the treatment of acute and chronic MND, with or without headache. To be of benefit, a stretching and strengthening exercise program should concentrate on the musculature of the cervical, shoulder-thoracic area, or both. A multimodal care approach of exercise, combined with mobilisation or manipulation for subacute and chronic MND with or without headache, reduced pain, improved function, and global perceived effect in the short and long term. The relative benefit of other treatments (such as physical modalities) compared with exercise or between different exercise programs needs to be explored. The quality of future trials should improve through more effective 'blinding' procedures and better control of compliance and co-intervention. Phase II trials would help identify the most effective treatment characteristics and dosages.

Non-invasive physical treatments for chronic/recurrent headache.

BACKGROUND: Non-invasive physical treatments are often used to treat common types of chronic/recurrent headache. OBJECTIVES: To quantify and compare the magnitude of short- and long-term effects of non-invasive physical treatments for chronic/recurrent headaches. SEARCH STRATEGY: We searched the following databases from their inception to November 2002: MEDLINE, EMBASE, BIOSIS, CINAHL, Science Citation Index, Dissertation Abstracts, CENTRAL, and the Specialised Register of the Cochrane Pain, Palliative Care and Supportive Care review group. Selected complementary medicine reference systems were searched as well. We also performed citation tracking and hand searching of potentially relevant journals. SELECTION CRITERIA: We included randomized and quasi-randomized controlled trials comparing non-invasive physical treatments for chronic/recurrent headaches to any type of control. DATA COLLECTION AND ANALYSIS: Two independent reviewers abstracted trial information and scored trials for methodological quality. Outcomes data were standardized into percentage point and effect size scores wherever possible. The strength of the evidence of effectiveness was assessed using pre-specified rules. MAIN RESULTS: Twenty-two studies with a total of 2628 patients (age 12 to 78 years) met the inclusion criteria. Five types of headache were studied: migraine, tension-type, cervicogenic, a mix of migraine and tension-type, and post-traumatic headache. Ten studies had methodological quality scores of 50 or more (out of a possible 100 points), but many limitations were identified. We were unable to pool data because of study heterogeneity. For the prophylactic treatment of migraine headache, there is evidence that spinal manipulation may be an effective treatment option with a short-term effect similar to that of a commonly used, effective drug (amitriptyline). Other possible treatment options with weaker evidence of effectiveness are pulsating electromagnetic fields and a combination of transcutaneous electrical nerve stimulation [TENS] and electrical neurotransmitter modulation. For the prophylactic treatment of chronic tension-type headache, amitriptyline is more effective than spinal manipulation during treatment. However, spinal manipulation is superior in the short term after cessation of both treatments. Other possible treatment options with weaker evidence of effectiveness are therapeutic touch; cranial electrotherapy; a combination of TENS and electrical neurotransmitter modulation; and a regimen of auto-massage, TENS, and stretching. For episodic tension-type headache, there is evidence that adding spinal manipulation to massage is not effective. For the prophylactic treatment of cervicogenic headache, there is evidence that both neck exercise (low-intensity endurance training) and spinal manipulation are effective in the short and long term when compared to no treatment. There is also evidence that spinal manipulation is effective in the short term when compared to massage or placebo spinal manipulation, and weaker evidence when compared to spinal mobilization. There is weaker evidence that spinal mobilization is more effective in the short term than cold packs in the treatment of post-traumatic headache. REVIEWERS' CONCLUSIONS: A few non-invasive physical treatments may be effective as prophylactic treatments for chronic/recurrent headaches. Based on trial results, these treatments appear to be associated with little risk of serious adverse effects. The clinical effectiveness and cost-effectiveness of non-invasive physical treatments require further research using scientifically rigorous methods. The heterogeneity of the studies included in this review means that the results of a few additional high-quality trials in the future could easily change the conclusions of our review.

Manipulation and mobilisation for mechanical neck disorders.

BACKGROUND: Neck disorders are common, disabling, and costly. The effectiveness of manipulation and mobilisation remains unclear. OBJECTIVES: To assess whether manipulation and mobilisation, either alone or in combination with other treatments, relieve pain or improve function/disability, patient satisfaction, and global perceived effect in adults with mechanical neck disorders (MND). SEARCH STRATEGY: Computerised bibliographic databases including CENTRAL, MEDLINE, EMBASE, MANTIS, CINAHL, and ICL, were searched without language restrictions from their respective starting dates to March 2002. SELECTION CRITERIA: The studies had to be randomised (RCT) or quasi-randomised and investigate the use of manipulation or mobilisation as a treatment for mechanical neck disorders. DATA COLLECTION AND ANALYSIS: Two independent reviewers conducted citation identification, study selection, data abstraction, and methodological quality assessment. Using a random effects model, relative risk and standardised mean differences were calculated. The reasonableness of combining studies was assessed on clinical and statistical grounds. In the absence of heterogeneity, pooled effect measures were calculated. MAIN RESULTS: Of the 33 selected trials, 42% were high quality trials. Single sessions of manipulation or multiple sessions (3 to 11 weeks) of manipulation or mobilisation, or manipulation and mobilisation showed a nonsignificant benefit in pain relief when assessed against placebo, control groups or other treatments for acute/subacute/chronic MNDs with or without headache. There was strong evidence of benefit favouring multimodal care over a waiting list control for pain reduction [pooled SMD -0.85 (95% CI: -1.20 to -0.50)], improvement in function [pooled SMD -0.57 (95% CI: -0.94 to -0.21)] and global perceived effect [SMD -2.73 (95% CI: -3.30 to -2.16)] for subacute/chronic MND with or without headache. The common elements in this care strategy were mobilisation and/or manipulation plus exercise. There was moderate evidence of no difference in effect when multimodal care was compared to various other treatments. REVIEWER'S CONCLUSIONS: Multimodal care has short-term and long-term maintained benefits for subacute/chronic MND with or without headache. The common elements in this care strategy were mobilisation and/or manipulation plus exercise. The evidence did not favour manipulation and/or mobilisation done alone or in combination with various other physical medicine agents; when compared to one another, neither was superior. There was insufficient evidence available to draw conclusions for neck disorder with radicular findings. The added benefit of exercise needs to be further explored. Factorial design would help determine the active treatment agent(s) within a treatment mix. Phase II trials would help identify the most effective treatment characteristics and dosages. Greater attention to methodological quality is needed.

Efficacy of spinal manipulation for chronic headache: a systematic review.

BACKGROUND: Chronic headache is a prevalent condition with substantial socioeconomic impact. Complementary or alternative therapies are increasingly being used by patients to treat headache pain, and spinal manipulative therapy (SMT) is among the most common of these. OBJECTIVE: To assess the efficacy/effectiveness of SMT for chronic headache through a systematic review of randomized clinical trials. STUDY SELECTION: Randomized clinical trials on chronic headache (tension, migraine and cervicogenic) were included in the review if they compared SMT with other interventions or placebo. The trials had to have at least 1 patient-rated outcome measure such as pain severity, frequency, duration, improvement, use of analgesics, disability, or quality of life. Studies were identified through a comprehensive search of MEDLINE (1966-1998) and EMBASE (1974-1998). Additionally, all available data from the Cumulative Index of Nursing and Allied Health Literature, the Chiropractic Research Archives Collection, and the Manual, Alternative, and Natural Therapies Information System were used, as well as material gathered through the citation tracking, and hand searching of non-indexed chiropractic, osteopathic, and manual medicine journals. DATA EXTRACTION: Information about outcome measures, interventions and effect sizes was used to evaluate treatment efficacy. Levels of evidence were determined by a classification system incorporating study validity and statistical significance of study results. Two authors independently extracted data and performed methodological scoring of selected trials. DATA SYNTHESIS: Nine trials involving 683 patients with chronic headache were included. The methodological quality (validity) scores ranged from 21 to 87 (100-point scale). The trials were too heterogeneous in terms of patient clinical characteristic, control groups, and outcome measures to warrant statistical pooling. Based on predefined criteria, there is moderate evidence that SMT has short-term efficacy similar to amitriptyline in the prophylactic treatment of chronic tension-type headache and migraine. SMT does not appear to improve outcomes when added to soft-tissue massage for episodic tension-type headache. There is moderate evidence that SMT is more efficacious than massage for cervicogenic headache. Sensitivity analyses showed that the results and the overall study conclusions remained the same even when substantial changes in the prespecified assumptions/rules regarding the evidence determination were applied. CONCLUSIONS: SMT appears to have a better effect than massage for cervicogenic headache. It also appears that SMT has an effect comparable to commonly used first-line prophylactic prescription medications for tension-type headache and migraine headache. This conclusion rests upon a few trials of adequate methodological quality. Before any firm conclusions can be drawn, further testing should be done in rigorously designed, executed, and analyzed trials with follow-up periods of sufficient length.

Chronic pediatric asthma and chiropractic spinal manipulation: a prospective clinical series and randomized clinical pilot study.

OBJECTIVES: The first objective was to determine if chiropractic spinal manipulative therapy (SMT) in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes in children. The second objective was to assess the feasibility of conducting a full-scale, randomized clinical trial in terms of recruitment, evaluation, treatment, and ability to deliver a sham SMT procedure. STUDY DESIGN: Prospective clinical case series combined with an observer-blinded, pilot randomized clinical trial with a 1-year follow-up period. SETTING: Primary contact, college outpatient clinic, and a pediatric hospital. PATIENTS: A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study. OUTCOME MEASURES: Pulmonary function tests; patient- and parent- or guardian-rated asthma-specific quality of life, asthma severity, and improvement; am and pm peak expiratory flow rates; and diary-based day and nighttime symptoms. INTERVENTIONS: Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase. Patients were randomly assigned to receive either active SMT or sham SMT in addition to their standardized ongoing medical management. RESULTS: It is possible to blind the participants to the nature of the SMT intervention, and a full-scale trial with the described design is feasible to conduct. At the end of the 12-week intervention phase, objective lung function tests and patient-rated day and nighttime symptoms based on diary recordings showed little or no change. Of the patient-rated measures, a reduction of approximately 20% in beta(2) bronchodilator use was seen (P =.10). The quality of life scores improved by 10% to 28% (P <.01), with the activity scale showing the most change. Asthma severity ratings showed a reduction of 39% (P <.001), and there was an overall improvement rating corresponding to 50% to 75%. The pulmonologist-rated improvement was small. Similarly, the improvements in parent- or guardian-rated outcomes were mostly small and not statistically significant. The changes in patient-rated severity and the improvement rating remained unchanged at 12-month posttreatment follow-up as assessed by a brief postal questionnaire. CONCLUSION: After 3 months of combining chiropractic SMT with optimal medical management for pediatric asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. These improvements were maintained at the 1-year follow-up assessment. There were no important changes in lung function or hyperresponsiveness at any time. The observed improvements are unlikely as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily. Further research is needed to assess which components of the chiropractic encounter are responsible for important improvements in patient-oriented outcomes so that they may be incorporated into the care of all patients with asthma.

A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain.

STUDY DESIGN: A randomized, parallel-group, single-blinded clinical trial was performed. After a 1-week baseline period, patients were randomized to 11 weeks of therapy, with posttreatment follow-up assessment 3, 6, and 12 months later. OBJECTIVES: To compare the relative efficacy of rehabilitative neck exercise and spinal manipulation for the management of patients with chronic neck pain. SUMMARY OF BACKGROUND DATA: Mechanical neck pain is a common condition associated with substantial morbidity and cost. Relatively little is known about the efficacy of spinal manipulation and exercise for chronic neck pain. Also, the combination of both therapies has yet to be explored. METHODS: Altogether, 191 patients with chronic mechanical neck pain were randomized to receive 20 sessions of spinal manipulation combined with rehabilitative neck exercise (spinal manipulation with exercise), MedX rehabilitative neck exercise, or spinal manipulation alone. The main outcome measures were patient-rated neck pain, neck disability, functional health status (as measured by Short Form-36 [SF-36]), global improvement, satisfaction with care, and medication use. Range of motion, muscle strength, and muscle endurance were assessed by examiners blinded to patients' treatment assignment. RESULTS: Clinical and demographic characteristics were similar among groups at baseline. A total of 93% of the patients completed the intervention phase. The response rate for the 12-month follow-up period was 84%. Except for patient satisfaction, where spinal manipulative therapy and exercise were superior to spinal manipulation with (P = 0.03), the group differences in patient-rated outcomes after 11 weeks of treatment were not statistically significant (P = 0.13). However, the spinal manipulative therapy and exercise group showed greater gains in all measures of strength, endurance, and range of motion than the spinal manipulation group (P < 0.05). The spinal manipulation with exercise group also demonstrated more improvement in flexion endurance and in flexion and rotation strength than the MedX group (P < 0.03). The MedX exercise group had larger gains in extension strength and flexion-extension range of motion than the spinal manipulation group (P < 0.05). During the follow-up year, a greater improvement in patient-rated outcomes were observed for spinal manipulation with exercise and for MedX exercise than for spinal manipulation alone (P = 0.01). Both exercise groups showed very similar levels of improvement in patient-rated outcomes, although the spinal manipulation and exercise group reported greater satisfaction with care (P < 0.01). CONCLUSIONS: For chronic neck pain, the use of strengthening exercise, whether in combination with spinal manipulation or in the form of a high-technology MedX program, appears to be more beneficial to patients with chronic neck pain than the use of spinal manipulation alone. The effect of low-technology exercise or spinal manipulative therapy alone, as compared with no treatment or placebo, and the optimal dose and relative cost effectiveness of these therapies, need to be evaluated in future studies.

Nonoperative treatments for sciatica: a pilot study for a randomized clinical trial.

OBJECTIVES: To assess the feasibility of patient recruitment, the ability of patients and clinicians to comply with study protocols, and the use of data collection instruments to collect cost-effectiveness data, and to obtain variability estimates for sample-size calculations for a full-scale trial. STUDY DESIGN: Prospective, observer-blinded, pilot randomized clinical trial. SETTING: Primary contact chiropractic and medical clinics. PATIENTS: Ages 20 to 65 years, with low back-related radiating leg pain (sciatica). OUTCOME MEASURES: Self-report questionnaires were administered at baseline and 3 and 12 weeks after randomization. The measures included leg and back pain severity, frequency and bothersomeness of symptoms, leg/back disability, medication use, global improvement, satisfaction, and health care utilization. INTERVENTIONS: Medical care, chiropractic care, and epidural steroid injections. RESULTS: A total of 706 persons were screened by phone to determine initial eligibility. Of these, over 90% of those persons contacted did not meet the entrance criteria. The most common reason for disqualification was that the duration of the complaint was longer than 3 months. Twenty patients were randomized into the study. All 3 groups showed substantial improvements in the main patient-rated outcomes at the end of the 12-week intervention phase. For leg pain, back pain, frequency and bothersomeness of leg symptoms, and Roland-Morris disability score, the percent improvement varied from 50% to 84%, and the corresponding effect sizes ranged from 0.8 to 2.2. Bothersomeness of leg symptoms was the most responsive outcome associated with the largest magnitude of effect size. All within-group changes from baseline were statistically significant (P <.01). No between-group comparisons were planned or performed because of the insufficient sample size and high risk of committing type I and type II errors. CONCLUSIONS: Pilot studies such as these are important for the determination of the feasibility of conducting costly, larger scale trials. Recruitment for a full-scale study of sciatica of 2 to 12 weeks duration is not feasible, given the methods used in this pilot study. Our results do indicate, however, that there are substantial numbers of patients with sciatica more chronic in nature who would be interested in participating in a similar study. In addition, collaboration with a local health maintenance organization would likely facilitate clinician referrals and optimize the recruitment process. Patient and provider compliance was high in the pilot study, which indicates that most study protocols are feasible. Additionally, we were able to collect complete outcomes data, including those regarding health care use. A suggested modification by investigators and outside consultants has resulted in the replacement of the medication group with a minimal intervention control group (ie, self-care advice). As a result, a second pilot study of patients with sciatica of more than 4 weeks duration has been planned before a full-scale trial is attempted.

Responsiveness of general health status in chronic low back pain: a comparison of the COOP charts and the SF-36.

The objective of this study was to compare the responsiveness and assess the concurrent validity of two functional health status instruments, the Dartmouth COOP charts and the SF-36 in chronic low-back pain (CLBP) patients. The data came from 129 of 174 patients who participated in a randomized clinical trial of the therapeutic management of CLBP. Reliable and valid disease-specific outcomes, patient-rated low-back pain and disability, were used as external criteria (EC) to identify improved and non-improved patients. Unpaired t-statistics and receiver operating characteristic (ROC) curve calculations were used to quantify responsiveness. The two instruments had sufficient and very similar responsiveness using both EC. Comparisons between improved and non-improved patients for the COOP charts and SF-36, respectively, using pain as EC, yielded differences which translated into large effect sizes (0.8 and 0.7) (P=0.0008 and 0.003). Using disability as EC, differences of moderate effect size were found (0.5 and 0.6) (P=0.02 and 0.002). The ROC curve calculations using pain as EC resulted in areas under the curve of 0.76 (95% CI: 0.64, 0.88) for the COOP charts, and 0.74 (95% CI: 0.60, 0.88) for the SF-36. The corresponding areas using disability as EC were 0.67 (95% CI: 0.55, 0.79) and 0.72 (95% CI: 0.60, 0.84). The best cut-off point in both instruments for differentiating between improved and non-improved patients was approximately six percentage points. The constructs of functional health status, as reflected in the global scores of the two instruments, are highly correlated (r=0.82). Six of the instruments' nine dimensions are moderately to highly correlated (r=0.52 to 0.86), and the overall canonical correlation was high (R=0.9). In conclusion, both instruments seem equally suitable for use as outcome measures in clinical trials on CLBP. The COOP charts are faster to fill out and score.

Spinal manipulation: current state of research and its indications.

Based on the most recent and comprehensive systematic reviews, there is moderate evidence of short-term efficacy for spinal manipulation in the treatment of both acute and chronic low back pain. There is insufficient data available to draw conclusions regarding the efficacy for lumbar radiculopathy. The evidence is also not conclusive for the long-term efficacy of spinal manipulation for any type of low back pain.

The efficacy of spinal manipulation, amitriptyline and the combination of both therapies for the prophylaxis of migraine headache.

BACKGROUND: Migraine headache affects approximately 11 million adults in the United States. Spinal manipulation is a common alternative therapy for headaches, but its efficacy compared with standard medical therapies is unknown. OBJECTIVE: To measure the relative efficacy of amitriptyline, spinal manipulation and the combination of both therapies for the prophylaxis of migraine headache. DESIGN: A prospective, randomized, parallel-group comparison. After a 4-wk baseline period, patients were randomly assigned to 8 wk of treatment, after which there was a 4-wk follow-up period. SETTING: Chiropractic college outpatient clinic. PARTICIPANTS: A total of 218 patients with the diagnosis of migraine headache. INTERVENTIONS: An 8-wk course of therapy with spinal manipulation, amitriptyline or a combination of the two treatments. MAIN OUTCOME MEASURES: A headache index score derived from a daily headache pain diary during the last 4 wk of treatment and during the 4-wk follow-up period. RESULTS: Clinically important improvement was observed in both primary and secondary outcomes in all three study groups over time. The reduction in headache index scores during treatment compared with baseline was 49% for amitriptyline, 40% for spinal manipulation and 41% for the combined group; p = .66. During the posttreatment follow-up period the reduction from baseline was 24% for amitriptyline, 42% for spinal manipulation and 25% for the combined group; p = .05. CONCLUSION: There was no advantage to combining amitriptyline and spinal manipulation for the treatment of migraine headache. Spinal manipulation seemed to be as effective as a well-established and efficacious treatment (amitriptyline), and on the basis of a benign side effects profile, it should be considered a treatment option for patients with frequent migraine headaches.

Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial.

OBJECTIVES: To study the relative efficacy of three different treatment for chronic low back pain (CLBP). Two preplanned comparisons were made: (a) Spinal manipulative therapy (SMT) combined with trunk strengthening exercises (TSE) vs. SMT combined with trunk stretching exercises, and (b) SMT combined with TSE vs. nonsteroidal anti-inflammatory drug (NSAID) therapy combined with TSE. STUDY DESIGN: Interdisciplinary, prospective, observer-blinded, randomized clinical trial with a 1-yr follow-up period. The trial evaluated therapies in combination only and was not designed to test the individual treatment components. SETTING: Primary contact, college out-patient clinic. PATIENTS: In total, 174 patients aged 20-60 yr were admitted to the study. MAIN OUTCOME MEASURES: Patient-rated low back pain, disability, and functional health status at 5 and 11 wk. INTERVENTIONS: Five weeks of SMT or NSAID therapy in combination with supervised trunk exercise, followed by and additional 6 wk of supervised exercise alone. RESULTS: Individual group comparisons after 5 and 11 wk of intervention on all three main outcome measures did not reveal any clear clinically important or statistically significant differences. There seemed to be a sustained reduction in medication use at the 1-yr follow-up. in the SMT/TSE group. Continuance of exercise during the follow-up year, regardless of type, was associated with a better outcome. CONCLUSION: Each of the three therapeutic regimens was associated with similar and clinically important improvement over time that was considered superior to the expected natural history of long-standing CLBP. For the management of CLBP, trunk exercise in combination with SMT or NSAID therapy seemed to be beneficial and worthwhile. The magnitude of nonspecific therapeutic (placebo) effects, cost-effectiveness and relative risks of side effects associated with these types of therapy need to be addressed in future studies.

Spinal manipulation vs. amitriptyline for the treatment of chronic tension-type headaches: a randomized clinical trial.

OBJECTIVE: To compare the effectiveness of spinal manipulation and pharmaceutical treatment (amitriptyline) for chronic tension-type headache. DESIGN: Randomized controlled trial using two parallel groups. The study consisted of a 2-wk baseline period, a 6-wk treatment period and a 4-wk posttreatment, follow-up period. SETTING: Chiropractic college outpatient clinic. PATIENTS: One hundred and fifty patients between the ages of 18 and 70 with a diagnosis of tension-type headaches of at least 3 months' duration at a frequency of at least once per wk. INTERVENTIONS: 6 wk of spinal manipulative therapy provided by chiropractors or 6 wk of amitriptyline treatment managed by a medical physician. MAIN OUTCOME MEASURES: Change in patient-reported daily headache intensity, weekly headache frequency, over-the-counter medication usage and functional health status (SF-36). RESULTS: A total of 448 people responded to the recruitment advertisements; 298 were excluded during the screening process. Of the 150 patients who were enrolled in the study, 24 (16%) dropped out: 5 (6.6%) from the spinal manipulative therapy and 19 (27.1%) from the amitriptyline therapy group. During the treatment period, both groups improved at very similar rates in all primary outcomes. In relation to baseline values at 4 wk after cessation of treatment, the spinal manipulation group showed a reduction of 32% in headache intensity, 42% in headache frequency, 30% in over-the-counter medication usage and an improvement of 16% in functional health status. By comparison, the amitriptyline therapy group showed no improvement or a slight worsening from baseline values in the same four major outcome measures. Controlling for baseline differences, all group differences at 4 wk after cessation of therapy were considered to be clinically important and were statistically significant. Of the patients who finished the study, 46 (82.1%) in the amitriptyline therapy group reported side effects that included drowsiness, dry mouth and weight gain. Three patients (4.3%) in the spinal manipulation group reported neck soreness and stiffness. CONCLUSIONS: The results of this study show that spinal manipulative therapy is an effective treatment for tension headaches. Amitriptyline therapy was slightly more effective in reducing pain at the end of the treatment period but was associated with more side effects. Four weeks after the cessation of treatment, however, the patients who received spinal manipulative therapy experienced a sustained therapeutic benefit in all major outcomes in contrast to the patients that received amitriptyline therapy, who reverted to baseline values. The sustained therapeutic benefit associated with spinal manipulation seemed to result in a decreased need for over-the-counter medication. There is a need to assess the effectiveness of spinal manipulative therapy beyond four weeks and to compare spinal manipulative therapy to an appropriate placebo such as sham manipulation in future clinical trials.

Chronic asthma and chiropractic spinal manipulation: a randomized clinical trial.

The purpose of this randomized patient- and observer-blinded cross-over trial was to evaluate the efficacy of chiropractic treatment in the management of chronic asthma when combined with pharmaceutical maintenance therapy. The trial was conducted at the National University Hospital's Out-patient Clinic in Copenhagen, Denmark. Thirty-one patients aged 18-44 years participated, all suffering from chronic asthma controlled by bronchodilators and/or inhaled steroids. Patients, or who had received chiropractic treatment for asthma within the last 5 years, who received oral steroids and immunotherapy, were not eligible. Patients were randomized to receive either active chiropractic spinal manipulative treatment or sham chiropractic spinal manipulative treatment twice weekly for 4 weeks, and then crossed over to the alternative treatment for another 4 weeks. Both phases were preceded and followed by a 2-week period without chiropractic treatment. The main outcome measurements were forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), daily use of inhaled bronchodilators, patient-rated asthma severity and non-specific bronchial reactivity (n-BR). Using the cross-over analysis, no clinically important or statistically significant differences were found between the active and sham chiropractic interventions on any of the main or secondary outcome measures. Objective lung function did not change during the study, but over the course of the study, non-specific bronchial hyperreactivity (n-BR) improved by 36% (P = 0.01) and patient-rated asthma severity decreased by 34% (P = 0.0002) compared with the baseline values.(ABSTRACT TRUNCATED AT 250 WORDS)

Chiropractic treatment of low back pain: a prospective survey.

The clinical course of low back pain (LBP) during chiropractic treatment has not previously been reported on the basis of a prospective survey. The prospective survey is based on patient questionnaires filled in before treatment was started, as well as 1, 3, 6 and 12 months later. Clinical examination was performed at entry and also 1 month later. Two hundred ninety-eight patients with acute or chronic LBP from ten different chiropractic clinics were selected sequentially for this study. At the time of first contact between these patients and the clinics, the current episode of LBP had lasted less than 1 wk in 30% of the patients and for more than 4 wk in 51%. Sixty-five percent had radiating pain into the lower extremity, and 38% were unable to work. Fifty-three percent of the patients had consulted a medical doctor or had received other types of treatment due to the current episode. Nineteen percent were referred by a medical doctor to the chiropractor. After each period of registration, approximately 75% of the patients reported being free of symptoms or feeling much better. The present study was designed to be compared to a similar investigation carried out in a general medical practice. A clear indication of a more favorable outcome was found in those patients receiving chiropractic treatment when compared to those receiving medical treatment, especially concerning such factors as ability to work, bedrest and use of medication. Only a randomized controlled clinical trial is suited for a direct comparison of the effect and cost of chiropractic and medical treatment of LBP.