The (cost-)effectiveness and cost-utility of a novel integrative care initiative for patients with chronic musculoskeletal pain: the pragmatic trial protocol of Network Pain Rehabilitation Limburg.

BACKGROUND: Rehabilitation care for patients with chronic musculoskeletal pain (CMP) is not optimally organized. The Network Pain Rehabilitation Limburg 2.0 (NPRL2.0) provides integrated care with a biopsychosocial approach and strives to improve the Quadruple Aim outcomes: pain-related disability of patients with CMP; experiences of care of patients with CMP; meaning in the work of healthcare professionals; and healthcare costs. Firstly, in this study, the effectiveness (with regard to the functioning and participation of patients) of primary care for patients with CMP will be assessed, comparing care organized following the NPRL2.0 procedure with usual care. Secondly, the cost-effectiveness and cost-utility with regard to health-related quality of life and healthcare costs will be assessed. And thirdly, the effect of duration of participation in a local network in primary care will be studied. METHODS: In this pragmatic study, it is expected that two local networks with 105 patients will participate in the prospective cohort study and six local networks with 184 patients in the stepped-wedge based design. Healthcare professionals in the local networks will recruit patients. INCLUSION CRITERIA: age ≥ 18 years; having CMP; willing to improve functioning despite pain; and adequate Dutch literacy. EXCLUSION CRITERIA: pregnancy; and having a treatable medical or psychiatric disease. Patients will complete questionnaires at baseline (T1), 3 months (T2), 6 months (T3), and 9 months (T4). Questionnaires at T1 and T4 will include the Pain Disability Index and Short Form Health Survey. Questionnaires at T1, T2, T3, and T4 will include the EQ-5D-5L, and iMTA Medical Consumption and Productivity Cost Questionnaires. Outcomes will be compared using linear mixed-model analysis and costs will be compared using bootstrapping methods. DISCUSSION: NPRL2.0 is a multidimensional, complex intervention, executed in daily practice, and therefore needing a pragmatic study design. The current study will assess NPRL2.0 with respect to the Quadruple Aim outcomes: patient health and costs. This will provide more information on the (cost-) effectiveness of the organization of care in a network structure regarding patients with CMP. The other two Quadruple Aim outcomes will be examined alongside this study. Trial registration Netherlands Trial Register: NL7643. https://www.trialregister.nl/trial/7643 .

Critical NIH Resources to Advance Therapies for Pain: Preclinical Screening Program and Phase II Human Clinical Trial Network.

Opioid-related death and overdose have now reached epidemic proportions. In response to this public health crisis, the National Institutes of Health (NIH) launched the Helping to End Addiction Long-term InitiativeSM, or NIH HEAL InitiativeSM, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Herein, we describe two NIH HEAL Initiative programs to accelerate development of non-opioid, non-addictive pain treatments: The Preclinical Screening Platform for Pain (PSPP) and Early Phase Pain Investigation Clinical Network (EPPIC-Net). These resources are provided at no cost to investigators, whether in academia or industry and whether within the USA or internationally. Both programs consider small molecules, biologics, devices, and natural products for acute and chronic pain, including repurposed and combination drugs. Importantly, confidentiality and intellectual property are protected. The PSPP provides a rigorous platform to identify and profile non-opioid, non-addictive therapeutics for pain. Accepted assets are evaluated in in vitro functional assays to rule out opioid receptor activity and to assess abuse liability. In vivo pharmacokinetic studies measure plasma and brain exposure to guide the dose range and pretreatment times for the side effect profile, efficacy, and abuse liability. Studies are conducted in accordance with published rigor criteria. EPPIC-Net provides academic and industry investigators with expert infrastructure for phase II testing of pain therapeutics across populations and the lifespan. For assets accepted after a rigorous, objective scientific review process, EPPIC-Net provides clinical trial design, management, implementation, and analysis.

Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation.

BACKGROUND: Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of, an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain. METHODS: This is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed. DISCUSSION: Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet. TRIAL REGISTRATION: The study was prospectively registered at ClinicalTrials.gov ( NCT04274439 , registered 18 February 2020).

The use of complementary and integrative health approaches for chronic musculoskeletal pain in younger US Veterans: An economic evaluation.

OBJECTIVES: To estimate the cost-effectiveness to the US Veterans Health Administration (VA) of the use of complementary and integrative health (CIH) approaches by younger Veterans with chronic musculoskeletal disorder (MSD) pain. PERSPECTIVE: VA healthcare system. METHODS: We used a propensity score-adjusted hierarchical linear modeling (HLM), and 2010-2013 VA administrative data to estimate differences in VA healthcare costs, pain intensity (0-10 numerical rating scale), and opioid use between CIH users and nonusers. We identified CIH use in Veterans' medical records through Current Procedural Terminology, VA workload tracking, and provider-type codes. RESULTS: We identified 30,634 younger Veterans with chronic MSD pain as using CIH and 195,424 with no CIH use. CIH users differed from nonusers across all baseline covariates except the Charlson comorbidity index. They also differed on annual pre-CIH-start healthcare costs ($10,729 versus $5,818), pain (4.33 versus 3.76), and opioid use (66.6% versus 54.0%). The HLM results indicated lower annual healthcare costs (-$637; 95% CI: -$1,023, -$247), lower pain (-0.34; -0.40, -0.27), and slightly higher (less than a percentage point) opioid use (0.8; 0.6, 0.9) for CIH users in the year after CIH start. Sensitivity analyses indicated similar results for three most-used CIH approaches (acupuncture, chiropractic care, and massage), but higher costs for those with eight or more CIH visits. CONCLUSIONS: On average CIH use appears associated with lower healthcare costs and pain and slightly higher opioid use in this population of younger Veterans with chronic musculoskeletal pain. Given the VA's growing interest in the use of CIH, further, more detailed analyses of its impacts are warranted.

Effectiveness and cost-effectiveness of acupuncture with Doin therapy for chronic neck pain: a study protocol for a multicentre, randomised controlled clinical trial.

INTRODUCTION: Doin therapy is a manual therapy used in Korean rehabilitation medicine. Recently, the use of acupuncture with Doin has increased in clinics and clinical trials have demonstrated its effects. However, well-designed studies examining the efficacy and cost-effectiveness of acupuncture with Doin therapy are rare. METHODS AND ANALYSIS: This multicentre, assessor-blinded, randomised controlled trial with two parallel groups aims to evaluate the clinical effects and cost-effectiveness of acupuncture with Doin therapy. A total of 124 patients (with a neck pain duration of 6 months or longer and a Numeric Rating Scale ≥5) will be recruited at five Korean medicine hospitals. Patients will be randomly allocated to acupuncture with Doin therapy (n=62) and acupuncture alone (n=62) for 5 weeks of treatment. This study will be carried out with outcome assessor and statistician blinding. The primary outcome measure will consist of improvement in neck pain using the Visual Analogue Scale at 6 weeks. The secondary outcomes including measures of pain, functional disability, health-related quality of life and economic evaluation will be conducted at 6 weeks, and 3, 6, 9 and 12 months after treatment ETHICS AND DISSEMINATION: The project is approved by the Institutional Review Board (IRB) of the Jaseng Hospital of Korean Medicine and the Kyung Hee University Korean Medicine Hospital at Gangdong. Dissemination will occur after the findings from this study are published in other peer reviewed journals. TRIAL REGISTRATION NUMBERS: NCT03558178; KCT0003068; Pre-results.

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 a Team-Based Integrative Medicine Approach to the Treatment of Back Pain.

OBJECTIVES: To report the results of health economic analyses comparing two treatment approaches for chronic low back pain (CLBP). DESIGN: Observational prospective cohort study comparing effectiveness and cost-effectiveness of CLBP care provided at an integrative care clinic with that provided in other clinics within the same hospital. CLBP-related medical utilization, function, quality of life, and days of work incapacity were self-reported at baseline, 3, 6, and 12 months. SETTINGS/LOCATION: Osher Clinical Center (OCC) based at a tertiary academic hospital (Brigham and Women's Hospital [BWH]) and other clinics at BWH. SUBJECTS: CLBP patients seeking care at OCC or non-OCC BWH clinics. INTERVENTIONS: Integrative or conventional care for CLBP as prescribed by the treating clinician(s). OUTCOME MEASURES: Quality-adjusted life years (QALYs) were estimated per treatment approach based on the SF-12. Cost per QALY gained was evaluated using an incremental cost-effectiveness ratio (ICER). ICERs based on CLBP-specific effectiveness measures (Roland Disability Questionnaire [RDQ] and bothersomeness of pain [BOP]) were exploratory outcomes. RESULTS: Total adjusted annual CLBP-related costs per patient were greater in the OCC versus non-OCC group ($11,526.73 vs. $6,810.63). Between group differences in QALYs were small and ICER estimate of cost per QALY gained was high ($436,676). However, unadjusted mean direct costs per patient decreased over time in the OCC group. Savings in direct costs of $391 (95% confidence interval: -1,078 to 1,861) were observed in the OCC group for the 6- to 12-month period, driven primarily by reduced medication usage. ICERs based on adjusted RDQ and BOP group differences showed cost of $2,073 and $4,203 for a one-point reduction per respective scale. CONCLUSIONS: When adjusted for baseline differences, self-reported costs were higher in the OCC group with only small effects on QALYs. However, trends toward decreased direct expenditures and medication usage over time warrant further investigation. Future studies evaluating potential benefits of integrative care models for the management of CLBP should employ randomized designs, longer observational periods, and explore multiple metrics of cost-effectiveness.

Comparison of outpatient reimbursement for interstitial cystitis/bladder pain syndrome and rheumatoid arthritis treatment in Taiwan: A nationwide population-based study.

OBJECTIVE: This study compared Taiwanese public health insurance outpatient reimbursements for interstitial cystitis (IC)/bladder pain syndrome (BPS) and rheumatoid arthritis (RA) treatment. METHODS: This observational study used data from the Taiwan Longitudinal Health Insurance Database between 2002 and 2013. Patients with International Classification of Diseases, Ninth Revision, Clinical Modification codes for IC/BPS and RA were selected and matched in a ratio of 1 : 5 based on index year. After adjustment for possible confounders, including age, sex, income, hospital levels of care, and reimbursements for 24 comorbidities, yearly and per-visit pharmacy, non-pharmacy, and total claims were determined. RESULTS: In all, 1438 IC/BPS and 7190 RA patients were identified in the database. IC/BPS patients were significantly younger, and the proportion of females in this group was higher. Income levels were lower in the IC/BPS cohort, but not significantly. There were no significant differences between cohorts in terms of reimbursements for treatment for comorbidities, with the exception of end-stage renal disease, for which reimbursement was higher in the RA cohort. After adjusting for confounders, the regression coefficient for IC/BPS to RA was significantly lower for yearly total pharmacy claims, yearly total claims, per-visit pharmacy claims, and total claims per visit. CONCLUSIONS: Outpatient reimbursement was significantly lower for IC/BPS than for RA treatment, primarily with regard to pharmacy costs. This indicates less medical utilization for IC/BPS, possibly due to poor treatment outcomes and copayment polices. Further advances in the treatment of IC/BPS and health budget reallocation are encouraged.

Prevalence and Cost Analysis of Chronic Pain After Hernia Repair: A Potential Alternative Approach With Neurostimulation.

OBJECTIVES: Chronic pain (CP) affects a significant number of patients following hernia repair, ranging from 11 to 54% in the literature. The aim of this study was to assess the prevalence, overall costs, and health care utilization associated with CP after hernia repair. MATERIALS AND METHODS: A retrospective longitudinal study was performed using the Truven MarketScan® data base to identify patients who develop chronic neuropathic posthernia repair pain from 2001 to 2012. Patients were grouped into CP and No Chronic Pain (No CP) cohorts. Patients were excluded if they 1) were under 18 years of age; 2) had a previous pain diagnosis; 3) had CP diagnosed <90 days after the index hernia repair; 4) had less than one year of follow-up; or 5) had less than one-year baseline record before hernia repair. Patients were grouped into the CP cohort if their CP diagnosis was made within the two years following index hernia repair. Total, outpatient, and pain prescription costs were collected in the period of five years prehernia to nine years posthernia repair. A longitudinal multivariate analysis was used to model the effects of chronic neuropathic posthernia repair pain on total inpatient/outpatient and pain prescription costs. RESULTS: We identified 76,173 patients who underwent hernia repair and met inclusion criteria (CP: n = 14,919, No CP: n = 61,254). There was a trend for increased total inpatient/outpatient and pain prescription costs one-year posthernia repair, when compared to baseline costs for both cohorts. In both cohorts, total inpatient/outpatient costs remained elevated from baseline through nine years posthernia repair, with the CP cohort experiencing significantly higher cumulative median costs (CP: $51,334, No CP: $37,388). The CP diagnosis year was associated with a 1.75-fold increase (p < 0.001) in total inpatient/outpatient costs and a 2.26-fold increase (p < 0.001) in pain prescription costs versus all other years. In the longitudinal analysis, the CP cohort had a 1.14-fold increase (p < 0.001) in total inpatient/outpatient costs and 2.00-fold increase (p < 0.001) in pain prescription costs. CONCLUSIONS: Our study demonstrates the prevalence of CP after hernia surgery to be nearly 20%, with significantly increased costs and healthcare resource utilization. While current treatment paradigms are effective for many, there remains a large number of patients that could benefit from an overall approach that includes nonopioid treatments, such as potentially incorporating neurostimulation, for CP that presents posthernia repair.

Comparative effectiveness and economic evaluation of Chuna manual therapy for chronic neck pain: protocol for a multicenter randomized controlled trial.

BACKGROUND: Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints. METHODS/DESIGN: This study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ≥ 3 months, numeric rating scale [NRS] of neck pain ≥ 5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n = 54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization. DISCUSSION: This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.

Health Care Utilization and Costs Associated With Pediatric Chronic Pain.

The population prevalence of pediatric chronic pain is not well characterized, in part because of a lack of nationally representative data. Previous research suggests that pediatric chronic pain prolongs inpatient stay and increases costs, but the population-level association between pediatric chronic pain and health care utilization is unclear. We use the 2016 National Survey of Children's Health to describe the prevalence of pediatric chronic pain, and compare health care utilization among children ages 0 to 17 years according to the presence of chronic pain. Using a sample of 43,712 children, we estimate the population prevalence of chronic pain to be 6%. In multivariable analysis, chronic pain was not associated with increased odds of primary care or mental health care use, but was associated with greater odds of using other specialty care (odds ratio [OR] = 2.01, 95% confidence interval [CI] = 1.62-2.47; P < .001), complementary and alternative medicine (OR = 2.32, 95% CI = 1.79-3.03; P < .001), and emergency care (OR = 1.62, 95% CI = 1.29-2.02; P < .001). In this population-based survey, children with chronic pain were more likely to use specialty care but not mental health care. The higher likelihood of emergency care use in this group raises the question of whether better management of pediatric chronic pain could reduce emergency department use. PERSPECTIVE: Among children with chronic pain, we show high rates of use of emergency care but limited use of mental health care, which may suggest opportunities to increase multidisciplinary treatment of chronic pain.

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.

Forecasting the future burden of opioids for osteoarthritis.

OBJECTIVE: To quantify the current national burden of opioids for osteoarthritis (OA) pain in Australia in terms of number of dispensed opioid prescriptions and associated costs, and to forecast the likely burden to the year 2030/31. DESIGN: Epidemiological modelling. METHODS: Published data were obtained on rates of opioid prescribing for people with OA and national OA prevalence projections. Trends in opioid dispensing from 2006 to 2016, and average costs for common opioid subtypes were obtained from the Pharmaceutical Benefits Scheme and Medicare Australia Statistics. Using these inputs, a model was developed to estimate the likely number of dispensed opioid prescriptions and costs to the public healthcare system by 2030/31. RESULTS: In 2015/16, an estimated 1.1 million opioid prescriptions were dispensed in Australia for 403,954 people with OA (of a total 2.2 million Australians with OA). Based on recent dispensing trends and OA prevalence projections, the number of dispensed opioid prescriptions is expected to nearly triple to 3,032,332 by 2030/31, for an estimated 562,610 people with OA. The estimated cost to the Australian healthcare system was $AUD25.2 million in 2015/16, rising to $AUD72.4 million by 2030/31. CONCLUSION: OA-related opioid dispensing and associated costs are set to increase substantially in Australia from 2015/16 to 2030/31. Use of opioids for OA pain is concerning given joint disease chronicity and the risk of adverse events, particularly among older people. These projections represent a conservative estimate of the full financial burden given additional costs associated with opioid-related harms and out-of-pocket costs borne by patients.

Effectiveness and Cost-Effectiveness of Tuina for Chronic Neck Pain: A Randomized Controlled Trial Comparing Tuina with a No-Intervention Waiting List.

OBJECTIVE: To evaluate whether tuina is more effective and cost-effective in reducing pain compared to no intervention in patients with chronic neck pain. DESIGN: Single-center randomized two-armed controlled trial. SETTING: University outpatient clinic specialized in Integrative Medicine. SUBJECTS: Outpatients with chronic neck pain were randomly allocated to tuina or no intervention. INTERVENTION: Six tuina treatments within 3 weeks. OUTCOME MEASURES: The primary outcome was the mean neck pain intensity during the previous 7 days on a visual analogue scale after 4 weeks (VAS, 0-100 mm, 0 = no pain, 100 = worst imaginable pain). Secondary outcomes included Neck Pain and Disability Scale (NPDS), Neck Disability Index (NDI), health-related quality of life (12-item quality-of-life questionnaire [SF-12]), medication intake, and cost-effectiveness after 4 and 12 weeks. Statistical analysis included analysis of covariance adjusted for baseline values and a full economic analysis from a societal perspective. RESULTS: Altogether, 92 outpatients were included (46 in both groups, 87% female, mean age 45.4 [standard deviation ±9.7], and mean VAS 57.7 ± 11.5). Tuina treatment led to a clinically meaningful reduction in neck pain intensity (group differences, 4 weeks: -22.8 mm [95% confidence interval, -31.7 to -13.8]; p < 0.001 and 12 weeks: -17.9 mm [-27.1 to -8.8], p < 0.001). No serious adverse events were observed. Total costs as well as quality-adjusted life years (QALYs) did not differ significantly between the groups. When taking group differences into account independently from their statistical significance, costs per QALY gained (incremental cost-effectiveness ratio) would range within a cost-effective area from €7,566 (for costs €10.28 per session) to €39,414 (cost €35 per session). CONCLUSION: An additional treatment with six tuina sessions over 3 weeks was effective, safe and relatively cost-effective for patients with chronic neck pain. A future trial should compare tuina to other best care options.

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.

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 .

[Differences in chronic back pain and joint disorders among health insurance funds : Results of a cross-sectional study based on the data of the Socioeconomic Panel from 2013]. / Kassenunterschiede bei chronischen Rückenschmerzen und Gelenkerkrankungen : Ergebnisse einer Querschnittsstudie auf Grundlage der Daten des sozioökonomischen Panels von 2013.

BACKGROUND: Health services research uses increasingly data from health insurance funds. It is well known that the funds differ with regard to sociodemographic characteristics and morbidity. It is uncertain if there are also differences in the prevalence of musculoskeletal disorders. OBJECTIVE: To compare the sociodemographic characteristics in various health insurance funds and the prevalence of joint disorders and chronic back pain. METHOD: The 30th wave (2013) of the German Socioeconomic Panel served as a database. Average age, sex distribution, nationality, education, and employment status were evaluated according to the health insurance funds. The prevalence of joint disorders and chronic back pain were also stratified according to the insurance funds and standardized according to age and sex. RESULTS: A total of 19,146 participants were included. Most participants (4,934) were insured by AOK, followed by BKK (2,632) and BARMER GEK (2,398). There were huge differences among the health insurance funds with regard to the sociodemographic characteristics. For example, the proportion of unemployed insurants was between 33.3 % (IKK) and 50.6 % (AOK). The prevalence of joint disorders standardized according to age and sex (20.7 %; 95 % CI: 20.1-21.3) was between 17.4 % (95 % CI: 15.8-19.0; PKV) and 22.4 % (95 % CI: 21.1-23.6; AOK). The prevalence of chronic back pain (18.0 %; 95 % CI: 17.4-18.5) was between 13.5 % (95 % CI: 12.2-14.9; PKV) and 20.6 % (95 % CI: 19.4-21.8; AOK). CONCLUSION: There are differences in the prevalence of musculoskeletal disorders among health insurance funds. The extrapolation of analyses of one health insurance fund to the German population is thus limited.