Temporal Trends and Geographic Variations in the Supply of Clinicians Who Provide Spinal Manipulation to Medicare Beneficiaries: A Serial Cross-Sectional Study.

OBJECTIVE: Spinal manipulation (SM) is recommended for first-line treatment of patients with low back pain. Inadequate access to SM may result in inequitable spine care for older US adults, but the supply of clinicians who provide SM under Medicare is uncertain. The purpose of this study was to measure temporal trends and geographic variations in the supply of clinicians who provide SM to Medicare beneficiaries. METHODS: Medicare is a US government-administered health insurance program that provides coverage primarily for older adults and people with disabilities. We used a serial cross-sectional design to examine Medicare administrative data from 2007 to 2015 for SM services identified by procedure code. We identified unique providers by National Provider Identifier and distinguished between chiropractors and other specialties by Physician Specialty Code. We calculated supply as the number of providers per 100 000 beneficiaries, stratified by geographic location and year. RESULTS: Of all clinicians who provide SM to Medicare beneficiaries, 97% to 98% are doctors of chiropractic. The geographic supply of doctors of chiropractic providing SM services in 2015 ranged from 20/100 000 in the District of Columbia to 260/100 000 in North Dakota. The supply of other specialists performing the same services ranged from fewer than 1/100 000 in 11 states to 8/100 000 in Colorado. Nationally, the number of Medicare-active chiropractors declined from 47 102 in 2007 to 45 543 in 2015. The count of other clinicians providing SM rose from 700 in 2007 to 1441 in 2015. CONCLUSION: Chiropractors constitute the vast majority of clinicians who bill for SM services to Medicare beneficiaries. The supply of Medicare-active SM providers varies widely by state. The overall supply of SM providers under Medicare is declining, while the supply of nonchiropractors who provide SM is growing.

The impact of patient preferences and costs on the appropriateness of spinal manipulation and mobilization for chronic low back pain and chronic neck pain.

BACKGROUND: Although the delivery of appropriate healthcare is an important goal, the definition of what constitutes appropriate care is not always agreed upon. The RAND/UCLA Appropriateness Method is one of the most well-known and used approaches to define care appropriateness from the clinical perspective-i.e., that the expected effectiveness of a treatment exceeds its expected risks. However, patient preferences (the patient perspective) and costs (the healthcare system perspective) are also important determinants of appropriateness and should be considered. METHODS: We examined the impact of including information on patient preferences and cost on expert panel ratings of clinical appropriateness for spinal mobilization and manipulation for chronic low back pain and chronic neck pain. RESULTS: The majority of panelists thought patient preferences were important to consider in determining appropriateness and that their inclusion could change ratings, and half thought the same about cost. However, few actually changed their appropriateness ratings based on the information presented on patient preferences regarding the use of these therapies and their costs. This could be because the panel received information on average patient preferences for spinal mobilization and manipulation whereas some panelists commented that appropriateness should be determined based on the preferences of individual patients. Also, because these therapies are not expensive, their ratings may not be cost sensitive. The panelists also generally agreed that preferences and costs would only impact their ratings if the therapies were considered clinically appropriate. CONCLUSIONS: This study found that the information presented on patient preferences and costs for spinal mobilization and manipulation had little impact on the rated appropriateness of these therapies for chronic low back pain and chronic neck pain. Although it was generally agreed that patient preferences and costs were important to the appropriateness of M/M for CLBP and CNP, it seems that what would be most important were the preferences of the individual patient, not patients in general, and large cost differentials.

Cost-effectiveness of spinal manipulation, exercise, and self-management for spinal pain using an individual participant data meta-analysis approach: a study protocol.

Background: Spinal pain is a common and disabling condition with considerable socioeconomic burden. Spine pain management in the United States has gathered increased scrutiny amidst concerns of overutilization of costly and potentially harmful interventions and diagnostic tests. Conservative interventions such as spinal manipulation, exercise and self-management may provide value for the care of spinal pain, but little is known regarding the cost-effectiveness of these interventions in the U.S. Our primary objective for this project is to estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management for spinal pain using an individual patient data meta-analysis approach. Methods/design: We will estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management using cost and clinical outcome data collected in eight randomized clinical trials performed in the U.S. Cost-effectiveness will be assessed from both societal and healthcare perspectives using QALYs, pain intensity, and disability as effectiveness measures. The eight randomized clinical trials used similar methods and included different combinations of spinal manipulation, exercise therapy, or self-management for spinal pain. They also collected similar clinical outcome, healthcare utilization, and work productivity data. A two-stage approach to individual patient data meta-analysis will be conducted. Discussion: This project capitalizes on a unique opportunity to combine clinical and economic data collected in a several clinical trials that used similar methods. The findings will provide important information on the value of spinal manipulation, exercise therapy, and self-management for spinal pain management in the U.S.

Effect on healthcare utilization and costs of spinal manual therapy for acute low back pain in routine care: A propensity score matched cohort study.

Spinal manual therapy (SMT) is a popular treatment option for low back pain (LBP). The aim of our analysis was to evaluate the effects of manual therapy delivered by general practitioners and ambulatory orthopedic surgeons in routine care on follow up consultations, sick leave, health service utilization and costs for acute LBP compared to matched patients not receiving manual therapy. This is a propensity score matched cohort study based on health claims data. We identified a total of 113.652 adult patients with acute LBP and no coded red flags of whom 21.021 (18%) received SMT by physicians. In the final analysis 17.965 patients in each group could be matched. Balance on patients' coded characteristics, comorbidity and prior health service utilization was achieved. The provision of SMT for acute LBP had no relevant impact on follow up visits and days of sick leave for LBP in the index billing period and the following year. SMT was associated with a higher proportion of imaging studies for LBP (30.6% vs. 23%, SMD: 0.164 [95% CI 0.143-0.185]). SMT did not lead to meaningful savings by replacing other health services for LBP. SMT for acute non-specific LBP in routine care was not clinically meaningful effective to reduce sick leave and reconsultation rates compared to no SMT and did not lead to meaningful savings by replacing other health services from the perspective of health insurance. This does not imply that SMT is ineffective but might reflect a problem with selection of suitable patients and the quality and quantity of SMT in routine care. National Manual Medicine societies should state clearly that imaging is not routinely needed prior to SMT in patients with low suspicion of presence of red flags and monitor the quality of provided services.

Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain.

BACKGROUND CONTEXT: Chronic neck pain is a prevalent and disabling condition among older adults. Despite the large burden of neck pain, little is known regarding the cost-effectiveness of commonly used treatments. PURPOSE: This study aimed to estimate the cost-effectiveness of home exercise and advice (HEA), spinal manipulative therapy (SMT) plus HEA, and supervised rehabilitative exercise (SRE) plus HEA. STUDY DESIGN/SETTING: Cost-effectiveness analysis conducted alongside a randomized clinical trial (RCT) was performed. PATIENT SAMPLE: A total of 241 older adults (≥65 years) with chronic mechanical neck pain comprised the patient sample. OUTCOME MEASURES: The outcome measures were direct and indirect costs, neck pain, neck disability, SF-6D-derived quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs) over a 1-year time horizon. METHODS: This work was supported by grants from the National Center for Complementary and Integrative Health (#F32AT007507), National Institute of Arthritis and Musculoskeletal and Skin Diseases (#P60AR062799), and Health Resources and Services Administration (#R18HP01425). The RCT is registered at ClinicalTrials.gov (#NCT00269308). A societal perspective was adopted for the primary analysis. A healthcare perspective was adopted as a sensitivity analysis. Cost-effectivenesswas a secondary aim of the RCT which was not powered for differences in costs or QALYs. Differences in costs and clinical outcomes were estimated using generalized estimating equations and linear mixed models, respectively. Cost-effectiveness acceptability curves were calculated to assess the uncertainty surrounding cost-effectiveness estimates. RESULTS: Total costs for SMT+HEA were 5% lower than HEA (mean difference: -$111; 95% confidence interval [CI] -$1,354 to $899) and 47% lower than SRE+HEA (mean difference: -$1,932; 95% CI -$2,796 to -$1,097). SMT+HEA also resulted in a greater reduction of neck pain over the year relative to HEA (0.57; 95% CI 0.23 to 0.92) and SRE+HEA (0.41; 95% CI 0.05 to 0.76). Differences in disability and QALYs favored SMT+HEA. The probability that adding SMT to HEA is cost-effective at willingness to pay thresholds of $50,000 to $200,000 per QALY gained ranges from 0.75 to 0.81. If adopting a health-care perspective, costs for SMT+HEA were 66% higher than HEA (mean difference: $515; 95% CI $225 to $1,094), resulting in an ICER of $55,975 per QALY gained. CONCLUSION: On average, SMT+HEA resulted in better clinical outcomes and lower total societal costs relative to SRE+HEA and HEA alone, with a 0.75 to 0.81 probability of cost-effectiveness for willingness to pay thresholds of $50,000 to $200,000 per QALY.

Cost analysis related to dose-response of spinal manipulative therapy for chronic low back pain: outcomes from a randomized controlled trial.

OBJECTIVE: The purpose of this analysis is to report the incremental costs and benefits of different doses of spinal manipulative therapy (SMT) in patients with chronic low back pain (LBP). METHODS: We randomized 400 patients with chronic LBP to receive a dose of 0, 6, 12, or 18 sessions of SMT. Participants were scheduled for 18 visits for 6 weeks and received SMT or light massage control from a doctor of chiropractic. Societal costs in the year after study enrollment were estimated using patient reports of health care use and lost productivity. The main health outcomes were the number of pain-free days and disability-free days. Multiple regression was performed on outcomes and log-transformed cost data. RESULTS: Lost productivity accounts for most societal costs of chronic LBP. Cost of treatment and lost productivity ranged from $3398 for 12 SMT sessions to $3815 for 0 SMT sessions with no statistically significant differences between groups. Baseline patient characteristics related to increase in costs were greater age (P = .03), greater disability (P = .01), lower quality-adjusted life year scores (P = .01), and higher costs in the period preceding enrollment (P < .01). Pain-free and disability-free days were greater for all SMT doses compared with control, but only SMT 12 yielded a statistically significant benefit of 22.9 pain-free days (P = .03) and 19.8 disability-free days (P = .04). No statistically significant group differences in quality-adjusted life years were noted. CONCLUSIONS: A dose of 12 SMT sessions yielded a modest benefit in pain-free and disability-free days. Care of chronic LBP with SMT did not increase the costs of treatment plus lost productivity.

Symptomatic magnetic resonance imaging-confirmed lumbar disk herniation patients: a comparative effectiveness prospective observational study of 2 age- and sex-matched cohorts treated with either high-velocity, low-amplitude spinal manipulative therapy or imaging-guided lumbar nerve root injections.

OBJECTIVES: The purpose of this study was to compare self-reported pain and "improvement" of patients with symptomatic, magnetic resonance imaging-confirmed, lumbar disk herniations treated with either high-velocity, low-amplitude spinal manipulative therapy (SMT) or nerve root injections (NRI). METHODS: This prospective cohort comparative effectiveness study included 102 age- and sex-matched patients treated with either NRI or SMT. Numerical rating scale (NRS) pain data were collected before treatment. One month after treatment, current NRS pain levels and overall improvement assessed using the Patient Global Impression of Change scale were recorded. The proportion of patients, "improved" or "worse," was calculated for each treatment. Comparison of pretreatment and 1-month NRS scores used the paired t test. Numerical rating scale and NRS change scores for the 2 groups were compared using the unpaired t test. The groups were also compared for "improvement" using the χ(2) test. Odds ratios with 95% confidence intervals were calculated. Average direct procedure costs for each treatment were calculated. RESULTS: No significant differences for self-reported pain or improvement were found between the 2 groups. "Improvement" was reported in 76.5% of SMT patients and in 62.7% of the NRI group. Both groups reported significantly reduced NRS scores at 1 month (P = .0001). Average cost for treatment with SMT was Swiss Francs 533.77 (US $558.75) and Swiss Francs 697 (US $729.61) for NRI. CONCLUSIONS: Most SMT and NRI patients with radicular low back pain and magnetic resonance imaging-confirmed disk herniation matching symptomatic presentation reported significant and clinically relevant reduction in self-reported pain level and increased global perception of improvement. There were no significant differences in outcomes between NRI and SMT. When considering direct procedure costs, the average cost of SMT was slightly less expensive.

Efficacy of manual therapy treatments for people with cervicogenic dizziness and pain: protocol of a randomised controlled trial.

BACKGROUND: Cervicogenic dizziness is a disabling condition characterised by postural unsteadiness that is aggravated by cervical spine movements and associated with a painful and/or stiff neck. Two manual therapy treatments (Mulligan's Sustained Natural Apophyseal Glides (SNAGs) and Maitland's passive joint mobilisations) are used by physiotherapists to treat this condition but there is little evidence from randomised controlled trials to support their use. The aim of this study is to conduct a randomised controlled trial to compare these two forms of manual therapy (Mulligan glides and Maitland mobilisations) to each other and to a placebo in reducing symptoms of cervicogenic dizziness in the longer term and to conduct an economic evaluation of the interventions. METHODS: Participants with symptoms of dizziness described as imbalance, together with a painful and/or stiff neck will be recruited via media releases, advertisements and mail-outs to medical practitioners in the Hunter region of NSW, Australia. Potential participants will be screened by a physiotherapist and a neurologist to rule out other causes of their dizziness. Once diagnosed with cervciogenic dizziness, 90 participants will be randomly allocated to one of three groups: Maitland mobilisations plus range-of-motion exercises, Mulligan SNAGs plus self-SNAG exercises or placebo. Participants will receive two to six treatments over six weeks. The trial will have unblinded treatment but blinded outcome assessments. Assessments will occur at baseline, post-treatment, six weeks, 12 weeks, six months and 12 months post treatment. The primary outcome will be intensity of dizziness. Other outcome measures will be frequency of dizziness, disability, intensity of cervical pain, cervical range of motion, balance, head repositioning, adverse effects and treatment satisfaction. Economic outcomes will also be collected. DISCUSSION: This paper describes the methods for a randomised controlled trial to evaluate the effectiveness of two manual therapy techniques in the treatment of people with cervicogenic dizziness for which there is limited established evidence-based treatment. TRIAL REGISTRATION: ACTRN12611000073909.

Use of chiropractic spinal manipulation in older adults is strongly correlated with supply.

STUDY DESIGN: Retrospective cross-sectional analysis of administrative data. OBJECTIVE: To examine the relationship between regional chiropractic supply and both use and utilization intensity of chiropractic services among Medicare beneficiaries. SUMMARY OF BACKGROUND DATA: Numerous studies have documented trends and patterns in the utilization of chiropractic services in the United States, but little is known about geographic variation in the relationship between chiropractic supply and utilization. METHODS: We analyzed Medicare claims data for services provided by chiropractic physicians in 2008. We aggregated the data to the hospital referral region level and used small area analysis techniques to generate descriptive statistics. We mapped geographic variations in chiropractic supply, use and utilization intensity (treatments per user), and quantified the variation by coefficient of variation and extremal ratio. We used Spearman rank correlation coefficient to correlate use with supply. We used a logistic regression model for chiropractic use and a multiple linear regression model for chiropractic utilization intensity. RESULTS: The average regional supply of chiropractic physicians was 21.5 per 100,000 adult capita. The average percentage of beneficiaries who used chiropractic was approximately 7.6 (SD, 3.9). The average utilization intensity was 10.6 (SD, 1.8). Regional chiropractic supply varied more than 14-fold, and chiropractic use varied more than 17-fold. Chiropractic supply and use were positively correlated (Spearman ρ, 0.68; P < 0.001). A low back or cervical spine problem was strongly associated with chiropractic use (odds ratios, 21.6 and 14.3, respectively). Increased chiropractic supply was associated with increased chiropractic use (odds ratio, 1.04) but not with increased chiropractic utilization intensity. CONCLUSION: Both the supply of chiropractors and the utilization of chiropractic by older US adults varied widely by region. Increased chiropractic supply was associated with increased chiropractic use but not with increased chiropractic utilization intensity. Utilization of chiropractic care is likely sensitive to both supply and patient preference.

Spinal manipulation epidemiology: systematic review of cost effectiveness studies.

BACKGROUND: Spinal manipulative therapy (SMT) is frequently used by health professionals to manage spinal pain. With many treatments having comparable outcomes to SMT, determining the cost-effectiveness of these treatments has been identified as a high research priority. OBJECTIVE: To investigate the cost-effectiveness of SMT compared to other treatment options for people with spinal pain of any duration. METHODS: We searched eight clinical and economic databases and the reference lists of relevant systematic reviews. Full economic evaluations conducted alongside randomised controlled trials with at least one SMT arm were eligible for inclusion. Two authors independently screened search results, extracted data and assessed risk of bias using the CHEC-list. RESULTS: Six cost-effectiveness and cost-utility analysis were included. All included studies had a low risk of bias scoring ≥16/19 on the CHEC-List. SMT was found to be a cost-effective treatment to manage neck and back pain when used alone or in combination with other techniques compared to GP care, exercise and physiotherapy. CONCLUSIONS: This review supports the use of SMT in clinical practice as a cost-effective treatment when used alone or in combination with other treatment approaches. However, as this conclusion is primarily based on single studies more high quality research is needed to identify whether these findings are applicable in other settings.

Value-based care in the management of spinal disorders: a systematic review of cost-utility analysis.

BACKGROUND: Spinal disorders are a major cause of disability and compromise in health-related quality of life. The direct and indirect costs of treating spinal disorders are estimated at more than $100 billion per year. With limited resources, the cost-utility of interventions is important for allocating resources. QUESTIONS/PURPOSES: We therefore performed a systematic review of the literature on cost-utility for nonoperative and operative interventions for treating spinal disorders. METHODS: We searched four databases for cost-utility analysis studies on low back pain management and identified 1004 items. The titles and abstracts of 752 were screened before selecting 27 studies for inclusion; full texts of these 27 studies were individually evaluated by five individuals. RESULTS: Studies of nonoperative treatments demonstrated greater value for graded activity over physical therapy and pain management; spinal manipulation over exercise; behavioral therapy and physiotherapy over advice; and acupuncture and exercise over usual general practitioner care. Circumferential fusion and femoral ring allograft had greater value than posterolateral fusion and titanium cage, respectively. The relative cost-utility of operative versus nonoperative interventions was variable with the most consistent evidence indicating superior value of operative care for treating spinal disorders involving nerve compression and instability. CONCLUSION: The literature on cost-utility for treating spinal disorders is limited. Studies addressing cost-utility of nonoperative and operative management of low back pain encompass a broad spectrum of diagnoses and direct comparison of treatments based on cost-utility thresholds for comparative effectiveness is limited by diversity among disorders and methods to assess cost-utility. Future research will benefit from uniform methods and comparison of treatments in cohorts with well-defined pathology.

Comparative effectiveness of exercise, acupuncture, and spinal manipulation for low back pain.

STUDY DESIGN: Systematic review. OBJECTIVE: We sought to answer the following clinical questions: (1) Is structured exercise more effective in the treatment of chronic low back pain (LBP) than spinal manipulative therapy (SMT)? (2) Is structured exercise more effective in the treatment of chronic LBP than acupuncture? (3) Is SMT more effective in the treatment of chronic LBP than acupuncture? (4) Do certain subgroups respond more favorably to specific treatments? (5) Are any of these treatments more cost-effective than the others? SUMMARY OF BACKGROUND DATA: Exercise, SMT, and acupuncture are widely used interventions in the treatment of chronic LBP. There is evidence that all of these approaches may offer some benefit for patients with chronic LBP when compared with usual care or no treatment. The relative benefits or cost-effectiveness of any one of these treatments when compared with the others are less well-defined, and it is difficult to identify specific subgroups of those with chronic LBP who may preferentially respond to a particular treatment modality. METHODS: A systematic review of the literature was performed to identify randomized controlled trials comparing a structured exercise program, SMT, or acupuncture with one another in patients with chronic LBP. RESULTS: Two studies were identified comparing the use of structured exercise with SMT that met our inclusion criteria. Although these studies utilized different approaches for the exercise and SMT treatment groups, patients in both groups improved in terms of pain and function in both studies. Using random-effects modeling, there was no difference between the exercise and SMT groups when the data from these studies were pooled. We identified no studies meeting our inclusion criteria that compared acupuncture with either structured exercise or SMT or that addressed the relative cost-effectiveness of these approaches in the treatment of patients with chronic LBP. CONCLUSION: The studies identified indicate that structured exercise and SMT appear to offer equivalent benefits in terms of pain and functional improvement for those with chronic LBP with clinical benefits evident within 8 weeks of care. However, the level of evidence is low. There is insufficient evidence to comment on the relative benefit of acupuncture compared with either structured exercise or SMT or to address the differential effects of structured exercise, SMT, or acupuncture for specific subgroups of individuals with chronic LBP. There is also insufficient evidence regarding the relative cost-effectiveness of structured exercise, SMT, or acupuncture in the treatment of chronic LBP. CLINICAL RECOMMENDATIONS: Structured exercise and SMT appear to offer equivalent benefits in the management of pain and function for patients with nonspecific chronic LBP. If no clinical benefit is appreciated after using one of these approaches for 8 weeks, then the treatment plan should be reevaluated and consideration should be given to modifying the treatment approach or using alternate forms of care. Strength of recommendation: Weak.There is insufficient evidence regarding the relative benefits of the acupuncture compared with either structured exercise or SMT in the treatment of chronic LBP.There is insufficient evidence to address differential effects of structured exercise, SMT, or acupuncture for specific subgroups of individuals with chronic LBP. There is insufficient evidence regarding the relative cost-effectiveness of structured exercise, SMT, or acupuncture in the treatment of chronic LBP.

United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care.

OBJECTIVE: To assess the cost effectiveness of adding spinal manipulation, exercise classes, or manipulation followed by exercise ("combined treatment") to "best care" in general practice for patients consulting with low back pain. DESIGN: Stochastic cost utility analysis alongside pragmatic randomised trial with factorial design. SETTING: 181 general practices and 63 community settings for physical treatments around 14 centres across the United Kingdom. PARTICIPANTS: 1287 (96%) of 1334 trial participants. MAIN OUTCOME MEASURES: Healthcare costs, quality adjusted life years (QALYs), and cost per QALY over 12 months. RESULTS: Over one year, mean treatment costs relative to "best care" were 195 pounds sterling (360 dollars; 279 euros; 95% credibility interval 85 pounds sterling to 308 pounds sterling) for manipulation, 140 pounds sterling (3 pounds sterling to 278 pounds sterling) for exercise, and 125 pounds sterling (21 pounds sterling to 228 pounds sterling) for combined treatment. All three active treatments increased participants' average QALYs compared with best care alone. Each extra QALY that combined treatment yielded relative to best care cost 3800 pounds sterling; in economic terms it had an "incremental cost effectiveness ratio" of 3800 pounds sterling. Manipulation alone had a ratio of 8700 pounds sterling relative to combined treatment. If the NHS was prepared to pay at least 10,000 pounds sterling for each extra QALY (lower than previous recommendations in the United Kingdom), manipulation alone would probably be the best strategy. If manipulation was not available, exercise would have an incremental cost effectiveness ratio of 8300 pounds sterling relative to best care. CONCLUSIONS: Spinal manipulation is a cost effective addition to "best care" for back pain in general practice. Manipulation alone probably gives better value for money than manipulation followed by exercise.

UK Back pain Exercise And Manipulation (UK BEAM) trial--national randomised trial of physical treatments for back pain in primary care: objectives, design and interventions [ISRCTN32683578].

BACKGROUND: Low back pain has major health and social implications. Although there have been many randomised controlled trials of manipulation and exercise for the management of low back pain, the role of these two treatments in its routine management remains unclear. A previous trial comparing private chiropractic treatment with National Health Service (NHS) outpatient treatment, which found a benefit from chiropractic treatment, has been criticised because it did not take treatment location into account. There are data to suggest that general exercise programmes may have beneficial effects on low back pain. The UK Medical Research Council (MRC) has funded this major trial of physical treatments for back pain, based in primary care. It aims to establish if, when added to best care in general practice, a defined package of spinal manipulation and a defined programme of exercise classes (Back to Fitness) improve participant-assessed outcomes. Additionally the trial compares outcomes between participants receiving the spinal manipulation in NHS premises and in private premises. DESIGN: Randomised controlled trial using a 3 x 2 factorial design. METHODS: We sought to randomise 1350 participants with simple low back pain of at least one month's duration. These came from 14 locations across the UK, each with a cluster of 10-15 general practices that were members of the MRC General Practice Research Framework (GPRF). All practices were trained in the active management of low back pain. Participants were randomised to this form of general practice care only, or this general practice care plus manipulation, or this general practice care plus exercise, or this general practice care plus manipulation followed by exercise. Those randomised to manipulation were further randomised to receive treatment in either NHS or private premises. Follow up was by postal questionnaire one, three and 12 months after randomisation. The primary analysis will consider the main treatment effects before interactions between the two treatment packages. Economic analysis will estimate the cost per unit of health utility gained by adding either or both of the treatment packages to general practice care.

A review of the evidence for the effectiveness, safety, and cost of acupuncture, massage therapy, and spinal manipulation for back pain.

BACKGROUND: Few treatments for back pain are supported by strong scientific evidence. Conventional treatments, although widely used, have had limited success. Dissatisfied patients have, therefore, turned to complementary and alternative medical therapies and providers for care for back pain. PURPOSE: To provide a rigorous and balanced summary of the best available evidence about the effectiveness, safety, and costs of the most popular complementary and alternative medical therapies used to treat back pain. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. STUDY SELECTION: Systematic reviews of randomized, controlled trials (RCTs) that were published since 1995 and that evaluated acupuncture, massage therapy, or spinal manipulation for nonspecific back pain and RCTs published since the reviews were conducted. DATA EXTRACTION: Two authors independently extracted data from the reviews (including number of RCTs, type of back pain, quality assessment, and conclusions) and original articles (including type of pain, comparison treatments, sample size, outcomes, follow-up intervals, loss to follow-up, and authors' conclusions). DATA SYNTHESIS: Because the quality of the 20 RCTs that evaluated acupuncture was generally poor, the effectiveness of acupuncture for treating acute or chronic back pain is unclear. The three RCTs that evaluated massage reported that this therapy is effective for subacute and chronic back pain. A meta-regression analysis of the results of 26 RCTs evaluating spinal manipulation for acute and chronic back pain reported that spinal manipulation was superior to sham therapies and therapies judged to have no evidence of a benefit but was not superior to effective conventional treatments. CONCLUSIONS: Initial studies have found massage to be effective for persistent back pain. Spinal manipulation has small clinical benefits that are equivalent to those of other commonly used therapies. The effectiveness of acupuncture remains unclear. All of these treatments seem to be relatively safe. Preliminary evidence suggests that massage, but not acupuncture or spinal manipulation, may reduce the costs of care after an initial course of therapy.

Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial.

OBJECTIVE: To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain. DESIGN: Economic evaluation alongside a randomised controlled trial. SETTING: Primary care. PARTICIPANTS: 183 patients with neck pain for at least two weeks recruited by 42 general practitioners and randomly allocated to manual therapy (n=60, spinal mobilisation), physiotherapy (n=59, mainly exercise), or general practitioner care (n=64, counselling, education, and drugs). MAIN OUTCOME MEASURES: Clinical outcomes were perceived recovery, intensity of pain, functional disability, and quality of life. Direct and indirect costs were measured by means of cost diaries that were kept by patients for one year. Differences in mean costs between groups, cost effectiveness, and cost utility ratios were evaluated by applying non-parametric bootstrapping techniques. RESULTS: The manual therapy group showed a faster improvement than the physiotherapy group and the general practitioner care group up to 26 weeks, but differences were negligible by follow up at 52 weeks. The total costs of manual therapy (447 euro; 273 pounds sterling; 402 dollars) were around one third of the costs of physiotherapy (1297 euro) and general practitioner care (1379 euro). These differences were significant: P<0.01 for manual therapy versus physiotherapy and manual therapy versus general practitioner care and P=0.55 for general practitioner care versus physiotherapy. The cost effectiveness ratios and the cost utility ratios showed that manual therapy was less costly and more effective than physiotherapy or general practitioner care. CONCLUSIONS: Manual therapy (spinal mobilisation) is more effective and less costly for treating neck pain than physiotherapy or care by a general practitioner.