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.

Cost comparison of two approaches to chiropractic care for patients with acute and sub-acute low Back pain care episodes: a cohort study.

BACKGROUND: Low back pain (LBP) imposes a costly burden upon patients, healthcare insurers, and society overall. Spinal manipulation as practiced by chiropractors has been found be cost-effective for treatment of LBP, but there is wide variation among chiropractors in their approach to clinical care, and the most cost-effective approach to chiropractic care is uncertain. To date, little has been published regarding the cost effectiveness of different approaches to chiropractic care. Thus, the current study presents a cost comparison between chiropractic approaches for patients with acute or subacute care episodes for low back pain. METHODS: We employed a retrospective cohort design to examine costs of chiropractic care among patients diagnosed with acute or subacute low back pain. The study time period ranged between 07/01/2016 and 12/22/2017. We compared cost outcomes for patients of two cohorts of chiropractors within health care system: Cohort 1) a general network of providers, and Cohort 2) a network providing conservative evidence-based care for rapid resolution of pain. We used generalized linear regression modeling to estimate the comparative influence of demographic and clinical factors on expenditures. RESULTS: A total of 25,621 unique patients were included in the analyses. The average cost per patient for Cohort 2 (mean allowed amount $252) was lower compared to Cohort 1 (mean allowed amount $326; 0.77, 95% CI 0.75-0.79, p < .001). Patient and clinician related factors such as health plan, provider region, and sex also significantly influenced costs. CONCLUSIONS: This study comprehensively analyzed cost data associated with the chiropractic care of adults with acute or sub-acute low back pain cared by two cohorts of chiropractic physicians. In general, providers in Cohort 2 were found to be significantly associated with lower costs for patient care as compared to Cohort 1. Utilization of a clinical model characterized by a patient-centered clinic approach and standardized, best-practice clinical protocols may offer lower cost when compared to non-standardized clinical approaches to chiropractic care.

Implementation of the Primary Spine Care Model in a Multi-Clinician Primary Care Setting: An Observational Cohort Study.

OBJECTIVE: The objective of this investigation was to compare the value of primary spine care (PSC) with usual care for management of patients with spine-related disorders (SRDs) within a primary care setting. METHODS: We retrospectively examined existing patient encounter data at 3 primary care sites within a multi-clinic health system. Designated clinicians serve in the role as PSC as the initial point of contact for spine patients, coordinate, and follow up for the duration of the episode of care. A PSC may be a chiropractor, physical therapist, or medical or osteopathic physician who has been trained to provide primary care for patients with SRDs. The PSC model of care had been introduced at site I (Lebanon, New Hampshire); sites II (Bedford, New Hampshire) and III (Nashua, New Hampshire) served as control sites where patients received usual care. To evaluate cost outcomes, we employed a controlled quasi-experimental design for analysis of health claims data. For analysis of clinical outcomes, we compared clinical records for PSC at site I and usual care at sites II and III, all with reference to usual care at site I. We examined clinical encounters occurring over a 24-month period, from February 1, 2016 through January 31, 2018. RESULTS: Primary spine care was associated with reduced total expenditures compared with usual care for SRDs. At site I, average per-patient expenditure was $162 in year 1 and $186 in year 2, compared with site II ($332 in year 1; $306 in year 2) and site III ($467 in year 1; $323 in year 2). CONCLUSION: Among patients with SRDs included in this study, implementation of the PSC model within a conventional primary care setting was associated with a trend toward reduced total expenditures for spine care compared with usual primary care. Implementation of PSC may lead to reduced costs and resource utilization, but may be no more effective than usual care regarding clinical outcomes.

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.

BACKGROUND: Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP). OBJECTIVE: Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care. METHODS: Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon. RESULTS: Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was "dominant" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost. DISCUSSION/CONCLUSIONS: Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.

Patient Willingness to Pay for Reductions in Chronic Low Back Pain and Chronic Neck Pain.

Many recommended nonpharmacologic therapies for patients with chronic spinal pain require visits to providers such as acupuncturists and chiropractors. Little information is available to inform third-party payers' coverage policies regarding ongoing use of these therapies. This study offers contingent valuation-based estimates of patient willingness to pay (WTP) for pain reductions from a large (n = 1,583) sample of patients using ongoing chiropractic care to manage their chronic low back and neck pain. Average WTP estimates were $45.98 (45.8) per month per 1-point reduction in current pain for chronic low back pain and $37.32 (38.0) for chronic neck pain. These estimates met a variety of validity checks including that individuals' values define a downward-sloping demand curve for these services. Comparing these WTP estimates with patients' actual use of chiropractic care over the next 3 months indicates that these patients are likely "buying" perceived pain reductions from what they believe their pain would have been if they didn't see their chiropractor-that is, they value maintenance of their current mild pain levels. These results provide some evidence for copay levels and their relationship to patient demand, but call into question ongoing coverage policies that require the documentation of continued improvement or of experienced clinical deterioration with treatment withdrawal. PERSPECTIVE: This study provides estimates of reported WTP for pain reduction from a large sample of patients using chiropractic care to manage their chronic spinal pain and compares these estimates to what these patients do for care over the next 3 months, to inform coverage policies for ongoing care.

Cost-effectiveness of hydrotherapy versus land-based therapy in patients with musculoskeletal disorders in Singapore.

BACKGROUND: The study evaluated the cost-effectiveness of hydrotherapy versus land-based therapy in patients with musculoskeletal disorders (MSDs) in Singapore. METHODS: A decision-analytic model was constructed to compare the cost-effectiveness of hydrotherapy to land-based therapy over 3 months from societal perspective. Target population comprised patients with low back pain (LBP), osteoarthritis (OA), rheumatoid arthritis (RA), total hip replacement (THR) and total knee replacement (TKR). Subgroup analyses were carried out to determine the cost-effectiveness of hydrotherapy in individual MSDs. Relative treatment effects were obtained through a systematic review of published data. RESULTS: Compared to land-based therapy, hydrotherapy was associated with an incremental cost-effectiveness ratio (ICER) of SGD 27 471 per quality-adjusted life-year (QALY) gained, which was below the willingness-to-pay threshold of SGD 70 000 per QALY (one gross domestic product per capita in Singapore in 2015). For the respective MSDs, hydrotherapy were dominant (more effective and less costly) in THR and TKR, cost-effective for LBP and RA, and not cost-effective for OA. Treatment adherence and cost of hydrotherapy were key drivers to the ICER values. CONCLUSIONS: Hydrotherapy was a cost-effective rehabilitation compared to land-based therapy for a population with MSDs in Singapore. However, the benefit of hydrotherapy was not observed in patients with OA.

Prevention and treatment of low back pain: evidence, challenges, and promising directions.

Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences. The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation. These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.

Comparison of the Cost-utility Analysis of Electroacupuncture and Nonsteroidal Antiinflammatory Drugs in the Treatment of Chronic Low Back Pain.

INTRODUCTION AND OBJECTIVE: Chronic low back pain (CLBP) is among the most common and important reasons for visiting a spine surgeon by patients; it is the second cause of visiting a doctor. Low back pain can cause considerable suffering and is a major financial burden in the society. There are many different methods available for the treatment of CLBP. This study aimed to compare the cost-utility of electroacupuncture (EA) and nonsteroidal antiinflammatory drugs (NSAIDs), as two common treatment methods for patients with CLBP. METHODS: This study was conducted on 100 patients suffering from CLBP. Cases were randomly selected from patients referring to two hospitals and four acupuncture clinics in Tehran. Forty-one patients received EA, and 59 patients were prescribed NSAIDs. The EuroQol five dimensions questionnaire was used to calculate quality-adjusted life-year. For calculating the total cost of the two treatment methods, face to face interview with patients was conducted by the researchers (using specific basic literature questionnaire), neurologists, and spine surgeons. The study perspective was social (direct and indirect costs calculated). RESULTS: The mean age for EA group was 41 ± 2.3 years, and for NSAIDs group, it was 38.0 ± 4.4 years. The average of the utility of patients under treatment by EA and NSAIDs was estimated as 0.70 and 0.627, respectively. The difference in utility between the two groups was significant (p ≤ 0.05). The total cost of EA and NSAIDs was estimated as 461.48 ± 57.8$ and 497.77 ± 85.2$ for one year (2016), respectively, which was also significant (p ≤ 0.05). CONCLUSION: The results indicate a significant difference between EA and NSAIDs in cases of both utility and total cost. The findings demonstrate that EA is more cost-effective than NSAIDs, as therefore can be considered as an alternative treatment for CLBP, with reasonable cost-utility.

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial.

BACKGROUND: Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery. METHODS/DESIGN: This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization. DISCUSSION: The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939 . Registered on 8 June 2016.

Antibiotic treatment In patients with chronic low back pain and Modic changes (the AIM study): study protocol for a randomised controlled trial.

BACKGROUND: A previous randomised controlled trial (RCT) of patients with chronic low back pain (LBP) and vertebral bone marrow (Modic) changes (MCs) on magnetic resonance imaging (MRI), reported that a 3-month, high-dose course of antibiotics had a better effect than placebo at 12 months' follow-up. The present study examines the effects of antibiotic treatment in chronic LBP patients with MCs at the level of a lumbar disc herniation, similar to the previous study. It also aims to assess the cost-effectiveness of the treatment, refine the MRI assessment of MCs, and further evaluate the impact of the treatment and the pathogenesis of MCs by studying genetic variability and the gene and protein expression of inflammatory biomarkers. METHODS/DESIGN: A double-blinded RCT is conducted at six hospitals in Norway, comparing orally administered amoxicillin 750 mg, or placebo three times a day, over a period of 100 days in patients with chronic LBP and type I or II MCs at the level of a MRI-confirmed lumbar disc herniation within the preceding 2 years. The inclusion will be stopped when at least 80 patients are included in each of the two MC type groups. In each MC type group, the study is designed to detect (ß = 0.1, α = 0.05) a mean difference of 4 (standard deviation 5) in the Roland Morris Disability Questionnaire score between the two treatment groups (amoxicillin or placebo) at 1-year follow-up. The study includes cost-effectiveness measures. Blood samples are assessed for security measures and for possible inflammatory mediators and biomarkers at different time points. MCs are evaluated on MRI at baseline and after 12 months. A blinded intention-to-treat analysis of treatment effects will be performed in the total sample and in each MC type group. DISCUSSION: To ensure the appropriate use of antibiotic treatment, its effect in chronic LBP patients with MCs should be re-assessed. This study will investigate the effects and cost-effectiveness of amoxicillin in patients with chronic LBP and MCs at the level of a disc herniation. The study may also help to refine imaging and characterise the biomarkers of MCs. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02323412 . Registered on 21 November 2014.

Effectiveness, costs and cost-effectiveness of chiropractic care and physiotherapy compared with information and advice in the treatment of non-specific chronic low back pain: study protocol for a randomised controlled trial.

BACKGROUND: Low back pain is a global public health problem and a leading cause of disability all over the world. The lifetime prevalence of low back pain is 70-80% and a significant proportion of people affected develop chronic low back pain (CLBP). Besides a severe negative impact on people's health and health-related quality of life, CLBP is associated with substantial costs for society. Medical costs for the management of CLBP and costs for production losses due to absenteeism from work are sizeable. Pharmaceuticals, physical activity, manipulation, and multidisciplinary rehabilitation interventions are examples of widely used treatments for CLBP. However, the scientific basis to recommend the use of one treatment over another is limited and more research is needed to study the effects, costs and cost-effectiveness of treatments for CLBP in clinical practice. The aim of the study is to evaluate the effectiveness (back pain-related functional limitation, back pain intensity, general health, health-related quality of life, and working status), costs (medical costs and costs for production losses) and cost-effectiveness of chiropractic care and physiotherapy when added to information and advice in the treatment of patients with non-specific CLBP in Sweden. METHODS/DESIGN: This is a pragmatic randomised controlled trial, where participants are recruited through six primary care rehabilitation units (PCRUs) in Stockholm County Council, Sweden. Individuals with non-specific CLBP are individually randomised to one of four treatment groups: 'information and advice'; 'physiotherapy, and information and advice'; 'chiropractic care, and information and advice'; or 'chiropractic care, physiotherapy, and information and advice'. A sample size of 600 participants will be recruited during a period of 33 months. A computer-based questionnaire is used to collect data on back pain-related functional limitation (Oswestry Disability Index), pain intensity (Numeric Rating Scale), general health (self-rated health), health-related quality of life (EQ-5D-3L), and working status (measured as percentage of full-time work). Data will be collected at baseline, and at 3, 6, and 12 months after baseline. DISCUSSION: The results from our study should be considered when producing evidence-based guidelines and recommendations on which treatment strategies to use for CLBP. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN15830360 . Registered prospectively on 2 February 2017.

Cost of opioid-treated chronic low back pain: Findings from a pilot randomized controlled trial of mindfulness meditation-based intervention.

OBJECTIVE: Opioid-treated chronic low back pain (CLBP) is debilitating, costly, and often refractory to existing treatments. This secondary analysis aims to pilot-test the hypothesis that mindfulness meditation (MM) can reduce economic burden related to opioid-treated CLBP. DESIGN: Twenty-six-week unblinded pilot randomized controlled trial, comparing MM, adjunctive to usual-care, to usual care alone. SETTING: Outpatient. PARTICIPANTS: Thirty-five adults with opioid-treated CLBP (≥30 morphine-equivalent mg/day) for 3 + months enrolled; none withdrew. INTERVENTION: Eight weekly therapist-led MM sessions and at-home practice. OUTCOME MEASURES: Costs related to self-reported healthcare utilization, medication use (direct costs), lost productivity (indirect costs), and total costs (direct + indirect costs) were calculated for 6-month pre-enrollment and postenrollment periods and compared within and between the groups. RESULTS: Participants (21 MM; 14 control) were 20 percent men, age 51.8 ± 9.7 years, with severe disability, opioid dose of 148.3 ± 129.2 morphine-equivalent mg/d, and individual annual income of $18,291 ± $19,345. At baseline, total costs were estimated at $15,497 ± 13,677 (direct: $10,635 ± 9,897; indirect: $4,862 ± 7,298) per participant. Although MM group participants, compared to controls, reduced their pain severity ratings and pain sensitivity to heat stimuli (p < 0.05), no statistically significant within-group changes or between-group differences in direct and indirect costs were noted. CONCLUSIONS: Adults with opioid-treated CLBP experience a high burden of disability despite the high costs of treatment. Although this pilot study did not show a statistically significant impact of MM on costs related to opioid-treated CLBP, MM can improve clinical outcomes and should be assessed in a larger trial with long-term follow-up.

Cost-effectiveness of Mindfulness-based Stress Reduction Versus Cognitive Behavioral Therapy or Usual Care Among Adults With Chronic Low Back Pain.

STUDY DESIGN: Economic evaluation alongside a randomized trial of cognitive-behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) versus usual care alone (UC) for chronic low back pain (CLBP). OBJECTIVE: To determine 1-year cost-effectiveness of CBT and MBSR compared to 33 UC. SUMMARY OF BACKGROUND DATA: CLBP is expensive in terms of healthcare costs and lost productivity. Mind-body interventions have been found effective for back pain, but their cost-effectiveness is unexplored. METHODS: A total of 342 adults in an integrated healthcare system with CLBP were randomized to receive MBSR (n = 116), CBT (n = 113), or UC (n = 113). CBT and MBSR were offered in 8-weekly 2-hour group sessions. Cost-effectiveness from the societal perspective was calculated as the incremental sum of healthcare costs and productivity losses over change in quality-adjusted life-years (QALYs). The payer perspective only included healthcare costs. This economic evaluation was limited to the 301 health plan members enrolled ≥180 days in the years pre-and postrandomization. RESULTS: Compared with UC, the mean incremental cost per participant to society of CBT was $125 (95% confidence interval, CI: -4103, 4307) and of MBSR was -$724 (CI: -4386, 2778)-that is, a net saving of $724. Incremental costs per participant to the health plan were $495 for CBT over UC and -$982 for MBSR, and incremental back-related costs per participant were $984 for CBT over UC and -$127 for MBSR. These costs (and cost savings) were associated with statistically significant gains in QALYs over UC: 0.041 (0.015, 0.067) for CBT and 0.034 (0.008, 0.060) for MBSR. CONCLUSION: In this setting CBT and MBSR have high probabilities of being cost-effective, and MBSR may be cost saving, as compared with UC for adults with CLBP. These findings suggest that MBSR, and to a lesser extent CBT, may provide cost-effective treatment for CLBP for payers and society. LEVEL OF EVIDENCE: 2.

Cost-effectiveness of using a motion-sensor biofeedback treatment approach for the management of sub-acute or chronic low back pain: economic evaluation alongside a randomised trial.

BACKGROUND: Low back pain is a common and costly condition internationally. There is high need to identify effective and economically efficient means for managing this problem. This study aimed to explore the cost-effectiveness of a novel motion-sensor biofeedback treatment approach in addition to guidelines-based care compared to guidelines-based care alone, from a societal perspective over a 12 month time horizon. METHOD: This was an incremental cost-effectiveness analysis conducted concurrently with a pilot, cluster randomized controlled trial. Health care resource use was collected using daily diaries and patient-self report at 3, 6 and 12 month follow-up assessments. Productivity was measured using industry classifications and participant self-reporting of ability to do their normal work with their present pain. Clinical effect was measured using the Patient Global Impression of Change measured at the 12 month follow-up assessment. Data were compared between groups using linear regression clustered by recruitment site. Bootstrap resampling was used to generate a visual representation of the 95% confidence interval for the incremental cost-effectiveness estimate. Two, one-way sensitivity analyses were undertaken to examine the robustness of findings to key assumptions. RESULT: There were n = 38 participants in the intervention group who completed the 12 month assessment and n = 45 in the control. The intervention group had greater use of trial-related medical and therapy resources [$477 per participant (95% CI: $447, $508)], but lower use of non-trial medical and therapy resources [$-53 per participant (95% CI: $-105, $-0)], and a greater improvement in productivity [$-5123 per participant (95% CI: $-10,174, $-72)]. Overall, the intervention dominated with a saving of $478,100 and an additional 41 participants self-rating as being very or much improved compared to the control. There was >99% confidence in this finding of dominance in both the primary and sensitivity analyses. CONCLUSIONS: The motion-sensor biofeedback treatment approach in addition to guidelines- based care appears to be both more clinically effective and economically efficient than guidelines- based care alone. This approach appears to be a viable means to manage low back pain and further research in this area should be a priority. TRIAL REGISTRATION: The randomised trial this research was based upon was prospectively registered on March 25th 2009 with the Australian New Zealand Clinical Trials Registry: ACTRN12609000157279 .

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

BACKGROUND: While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. METHODS/DESIGN: This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. DISCUSSION: This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Effectiveness and Economic Evaluation of Chiropractic Care for the Treatment of Low Back Pain: A Systematic Review of Pragmatic Studies.

BACKGROUND CONTEXT: Low back pain (LBP) is one of the leading causes of disability worldwide and among the most common reasons for seeking primary sector care. Chiropractors, physical therapists and general practitioners are among those providers that treat LBP patients, but there is only limited evidence regarding the effectiveness and economic evaluation of care offered by these provider groups. PURPOSE: To estimate the clinical effectiveness and to systematically review the literature of full economic evaluation of chiropractic care compared to other commonly used care approaches among adult patients with non-specific LBP. STUDY DESIGN: Systematic reviews of interventions and economic evaluations. METHODS: A comprehensive search strategy was conducted to identify 1) pragmatic randomized controlled trials (RCTs) and/or 2) full economic evaluations of chiropractic care for low back pain compared to standard care delivered by other healthcare providers. Studies published between 1990 and 4th June 2015 were considered. Primary outcomes included pain, functional status and global improvement. Study selection, critical quality appraisal and data extraction were conducted by two independent reviewers. Data from RCTs with low risk of bias were included in a meta-analysis to determine effect estimates. Cost estimates of full economic evaluations were converted to 2015 USD and results summarized using Slavin's qualitative best-evidence synthesis. RESULTS: Six RCTs and three full economic evaluations were scientifically admissible. Five RCTs with low risk of bias compared chiropractic care to exercise therapy (n = 1), physical therapy (n = 3) and medical care (n = 1). Overall, we found similar effects for chiropractic care and the other types of care and no reports of serious adverse events. Three low to high quality full economic evaluations studies (one cost-effectiveness, one cost-minimization and one cost-benefit) compared chiropractic to medical care. Given the divergent conclusions (favours chiropractic, favours medical care, equivalent options), mixed-evidence was found for economic evaluations of chiropractic care compared to medical care. CONCLUSION: Moderate evidence suggests that chiropractic care for LBP appears to be equally effective as physical therapy. Limited evidence suggests the same conclusion when chiropractic care is compared to exercise therapy and medical care although no firm conclusion can be reached at this time. No serious adverse events were reported for any type of care. Our review was also unable to clarify whether chiropractic or medical care is more cost-effective. Given the limited available evidence, the decision to seek or to refer patients for chiropractic care should be based on patient preference and values. Future studies are likely to have an important impact on our estimates as these were based on only a few admissible studies.

Yoga versus education for Veterans with chronic low back pain: study protocol for a randomized controlled trial.

BACKGROUND: Chronic low back pain is the most frequent pain condition in Veterans and causes substantial suffering, decreased functional capacity, and lower quality of life. Symptoms of post-traumatic stress, depression, and mild traumatic brain injury are highly prevalent in Veterans with back pain. Yoga for low back pain has been demonstrated to be effective for civilians in randomized controlled trials. However, it is unknown if results from previously published trials generalize to military populations. METHODS/DESIGN: This study is a parallel randomized controlled trial comparing yoga to education for 120 Veterans with chronic low back pain. Participants are Veterans ≥18 years old with low back pain present on at least half the days in the past six months and a self-reported average pain intensity in the previous week of ≥4 on a 0-10 scale. The 24-week study has an initial 12-week intervention period, where participants are randomized equally into (1) a standardized weekly group yoga class with home practice or (2) education delivered with a self-care book. Primary outcome measures are change at 12 weeks in low back pain intensity measured by the Defense and Veterans Pain Rating Scale (0-10) and back-related function using the 23-point Roland Morris Disability Questionnaire. In the subsequent 12-week follow-up period, yoga participants are encouraged to continue home yoga practice and education participants continue following recommendations from the book. Qualitative interviews with Veterans in the yoga group and their partners explore the impact of chronic low back pain and yoga on family relationships. We also assess cost-effectiveness from three perspectives: the Veteran, the Veterans Health Administration, and society using electronic medical records, self-reported cost data, and study records. DISCUSSION: This study will help determine if yoga can become an effective treatment for Veterans with chronic low back pain and psychological comorbidities. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02224183.

Variations in Patterns of Utilization and Charges for the Care of Low Back Pain in North Carolina, 2000 to 2009: A Statewide Claims' Data Analysis.

OBJECTIVES: The purpose of the study was to compare utilization and charges generated by medical doctors (MD), doctors of chiropractic (DC) and physical therapists (PT) by patterns of care for the treatment of low back pain in North Carolina. METHODS: This was an analysis of low-back-pain-related closed claim data from the North Carolina State Health Plan for Teachers and State Employees from 2000 to 2009. Data were extracted from Blue Cross Blue Shield of North Carolina for the North Carolina State Health Plan using International Classification of Diseases, 9th Revision diagnostic codes for uncomplicated low back pain (ULBP) and complicated low back pain (CLBP). RESULTS: Care patterns with single-provider types and no referrals incurred the least charges on average for both ULBP and CLBP. When care did not include referral providers or services, for ULBP, MD and DC care was on average $465 less than MD and PT care. For CLBP, MD and DC care averaged $965 more than MD and PT care. However, when care involved referral providers or services, MD and DC care was on average $1600 less when compared to MD and PT care for ULBP and $1885 less for CLBP. Risk-adjusted charges (available 2006-2009) for patients in the middle quintile of risk were significantly less for DC care patterns. CONCLUSIONS: Chiropractic care alone or DC with MD care incurred appreciably fewer charges for ULBP than MD care with or without PT care. This finding was reversed for CLBP. Adjusted charges for both ULBP and CLBP patients were significantly lower for DC patients.

Local, national, and service component cost variations in the management of low back pain: Considerations for the clinician.

In the past two decades, the cost associated with managing low back pain has increased significantly. Improved consciousness of how clinicians utilize resources when managing low back pain is necessary in the current economic climate. The goal of this review is to examine the component costs associated with managing low back pain and provide practical solutions for reducing healthcare costs. This is accomplished by utilizing examples from a major metropolitan area with several major academic institutions and private health care centers. It is clear that there is considerable local and national variation in the component costs of managing low back pain, including physician visits, imaging studies, medications, and therapy services. By being well informed about these variations in one's environment, clinicians and patients alike can make strides towards reducing the financial impact of low back pain. Investigation of the cost discrepancies for services within one's community of practice is important. Improved public access to both cost and outcomes data is needed.

The Association Between Use of Chiropractic Care and Costs of Care Among Older Medicare Patients With Chronic Low Back Pain and Multiple Comorbidities.

OBJECTIVE: The purpose of this study was to determine whether use of chiropractic manipulative treatment (CMT) was associated with lower healthcare costs among multiply-comorbid Medicare beneficiaries with an episode of chronic low back pain (cLBP). METHODS: We conducted an observational, retrospective study of 2006 to 2012 Medicare fee-for-service reimbursements for 72326 multiply-comorbid patients aged 66 and older with cLBP episodes and 1 of 4 treatment exposures: chiropractic manipulative treatment (CMT) alone, CMT followed or preceded by conventional medical care, or conventional medical care alone. We used propensity score weighting to address selection bias. RESULTS: After propensity score weighting, total and per-episode day Part A, Part B, and Part D Medicare reimbursements during the cLBP treatment episode were lowest for patients who used CMT alone; these patients had higher rates of healthcare use for low back pain but lower rates of back surgery in the year following the treatment episode. Expenditures were greatest for patients receiving medical care alone; order was irrelevant when both CMT and medical treatment were provided. Patients who used only CMT had the lowest annual growth rates in almost all Medicare expenditure categories. While patients who used only CMT had the lowest Part A and Part B expenditures per episode day, we found no indication of lower psychiatric or pain medication expenditures associated with CMT. CONCLUSIONS: This study found that older multiply-comorbid patients who used only CMT during their cLBP episodes had lower overall costs of care, shorter episodes, and lower cost of care per episode day than patients in the other treatment groups. Further, costs of care for the episode and per episode day were lower for patients who used a combination of CMT and conventional medical care than for patients who did not use any CMT. These findings support initial CMT use in the treatment of, and possibly broader chiropractic management of, older multiply-comorbid cLBP patients.