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Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial.

ABSTRACT: Low back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies.This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need. 2) Preventive treatment (clinician controlled), receiving care on a regular basis. Eligibility screening takes place in two phases: first, when assessing the primary inclusion/exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages.This study investigates a manual strategy (chiropractic maintenance care) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach. Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results.Clinical trials.gov; NCT01539863, February 22, 2012. The first patient was randomized into the study on April 13th 2012.

SUBMITTER: Eklund A

PROVIDER: S-EPMC3984260 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial.

Eklund Andreas A Axén Iben I Kongsted Alice A Lohela-Karlsson Malin M Leboeuf-Yde Charlotte C Jensen Irene I

Trials 20140402

<h4>Background</h4>Low back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies ...[more]

PMID: 24690201

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Project description:ObjectivesTo assess the effectiveness and cost-utility of a multifaceted eHealth strategy compared to usual care in improving patients' back pain beliefs, and in decreasing disability and absenteeism.DesignStepped-wedge cluster randomised trial with parallel economic evaluation.SettingDutch primary healthcare.ParticipantsPatients diagnosed with non-specific low back pain by their general practitioner or physiotherapist. Patients with serious comorbidities or confirmed pregnancy were excluded. 779 patients were randomised into intervention group (n=331, 59% female; 60.4% completed study) or control group (n=448, 57% female; 77.5% completed study).InterventionsThe intervention consisted of a multifaceted eHealth strategy that included a (mobile) website, digital monthly newsletters, and social media platforms. The website provided information about back pain, practical advice (eg, on self-management), working and returning to work with back pain, exercise tips, and short video messages from healthcare providers and patients providing information and tips. The control consisted of a digital patient information letter. Patients and outcome assessors were blinded to group allocation.Primary and secondary outcome measuresThe primary outcome was back pain beliefs. Secondary outcome measures were disability and absenteeism, and for the preplanned economic evaluation quality of life and societal costs were measured.ResultsThere were no between-group differences in back pain beliefs, disability, or absenteeism. Mean intervention costs were €70- and the societal cost difference was €535-in favour of the intervention group, but no significant cost savings were found. The incremental cost-effectiveness ratio indicated that the intervention dominated usual care and the probability of cost-effectiveness was 0.85 on a willingness-to-pay of €10.000/quality adjusted life year (QALY).ConclusionsA multifaceted eHealth strategy was not effective in improving patients' back pain beliefs or in decreasing disability and absenteeism, but showed promising cost-utility results based on QALYs.Trial registration numberNTR4329.

Project description:IntroductionLow back pain (LBP) is recognised globally as a prevalent, costly and disabling condition. Recurrences are common and contribute to much of the burden of LBP. Current evidence favours exercise and education for prevention of LBP recurrence, but an optimal intervention has not yet been established. Walking is a simple, widely accessible, low-cost intervention that has yet to be evaluated. This randomised controlled trial (RCT) aims to establish the effectiveness and cost-effectiveness of a progressive and individualised walking and education programme (intervention) for the prevention of LBP recurrences in adults compared with no treatment (control).Methods and analysisA pragmatic, two-armed RCT comparing walking and education (n=349) with a no treatment control group (n=349). Inclusion criteria are adults recovered from an episode of non-specific LBP within the last 6 months. Those allocated to the intervention group will receive six sessions (three face to face and three telephone delivered) with a trained physiotherapist to facilitate a progressive walking programme and education over a 6-month period. The primary outcome will be days to first recurrence of an episode of activity-limiting LBP. The secondary outcomes include days to recurrence of an episode of LBP, days to recurrence of an episode of LBP leading to care seeking, disability and quality of life measured at 3, 6, 9 and 12 months and costs associated with LBP recurrence. All participants will be followed up monthly for a minimum of 12 months. The primary intention-to-treat analysis will assess difference in survival curves (days to recurrence) using the log-rank statistic. The cost-effectiveness analysis will be conducted from the societal perspective.Ethics and disseminationApproved by Macquarie University Human Research Ethics Committee (Reference: 5201949218164, May 2019). Findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberACTRN12619001134112.

Project description:BackgroundDigital therapeutic care apps provide a new effective and scalable approach for people with nonspecific low back pain (LBP). Digital therapeutic care apps are also driven by personalized decision-support interventions that support the user in self-managing LBP, and may induce prolonged behavior change to reduce the frequency and intensity of pain episodes. However, these therapeutic apps are associated with high attrition rates, and the initial prescription cost is higher than that of face-to-face physiotherapy. In Germany, digital therapeutic care apps are now being reimbursed by statutory health insurance; however, price targets and cost-driving factors for the formation of the reimbursement rate remain unexplored.ObjectiveThe aim of this study was to evaluate the cost-effectiveness of a digital therapeutic care app compared to treatment as usual (TAU) in Germany. We further aimed to explore under which circumstances the reimbursement rate could be modified to consider value-based pricing.MethodsWe developed a state-transition Markov model based on a best-practice analysis of prior LBP-related decision-analytic models, and evaluated the cost utility of a digital therapeutic care app compared to TAU in Germany. Based on a 3-year time horizon, we simulated the incremental cost and quality-adjusted life years (QALYs) for people with nonacute LBP from the societal perspective. In the deterministic sensitivity and scenario analyses, we focused on diverging attrition rates and app cost to assess our model's robustness and conditions for changing the reimbursement rate. All costs are reported in Euro (€1=US $1.12).ResultsOur base case results indicated that the digital therapeutic care strategy led to an incremental cost of €121.59, but also generated 0.0221 additional QALYs compared to the TAU strategy, with an estimated incremental cost-effectiveness ratio (ICER) of €5486 per QALY. The sensitivity analysis revealed that the reimbursement rate and the capability of digital therapeutic care to prevent reoccurring LBP episodes have a significant impact on the ICER. At the same time, the other parameters remained unaffected and thus supported the robustness of our model. In the scenario analysis, the different model time horizons and attrition rates strongly influenced the economic outcome. Reducing the cost of the app to €99 per 3 months or decreasing the app's attrition rate resulted in digital therapeutic care being significantly less costly with more generated QALYs, and is thus considered to be the dominant strategy over TAU.ConclusionsThe current reimbursement rate for a digital therapeutic care app in the statutory health insurance can be considered a cost-effective measure compared to TAU. The app's attrition rate and effect on the patient's prolonged behavior change essentially influence the settlement of an appropriate reimbursement rate. Future value-based pricing targets should focus on additional outcome parameters besides pain intensity and functional disability by including attrition rates and the app's long-term effect on quality of life.

Project description:BACKGROUND:Chronic low back pain (CLBP) is a highly prevalent condition that has substantial impact on patients, the healthcare system and society. Pain management services (PMS), which aim to address the complex nature of back pain, are recommended in clinical practice guidelines to manage CLBP. Although the effectiveness of such services has been widely investigated in relation to CLBP, the quality of evidence underpinning the use of these services remains moderate. Therefore the aim is to summarize and critically appraise the current evidence for the cost effectiveness of pain management services for managing chronic back pain. METHODS:Electronic searches were conducted in MEDLINE, EMBASE and PsycINFO from their inception to February 2019. Full economic evaluations undertaken from any perspective conducted alongside randomized clinical trials (RCTs) or based on decision analysis models were included. Cochrane Back Review Group (CBRG) risk assessment and the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist were used to assess the methodological quality of eligible studies. RESULTS:Five studies fulfilled eligibility criteria. The interventions varied significantly between studies in terms of the number and types of treatment modalities, intensity and the duration of the program. Interventions were compared with either standard care, which varied according to the country and the setting; or to surgical interventions. Three studies showed that pain management services are cost effective, while two studies showed that these services are not cost effective. In this review, three out of five studies had a high risk of bias based on the design of the randomised controlled trials (RCTs). In addition, there were limitations in the statistical and sensitivity analyses in the economic evaluations. Therefore, the results from these studies need to be interpreted with caution. CONCLUSION:Pain management services may be cost effective for the management of low back pain. However, this systematic review highlights the variability of evidence supporting pain management services for patients with back pain. This is due to the quality of the published studies and the variability of the setting, interventions, comparators and outcomes.

Project description:Study designMarkov model.ObjectiveFurther validity test of a previously published model.Summary of background dataThe previous model was built using data from ten randomized trials and examined the 1-year effectiveness and cost-effectiveness of 17 nonpharmacologic interventions for chronic low back pain (CLBP), each compared to usual care alone. This update incorporated data from five additional trials.MethodsBased on transition probabilities that were estimated using patient-level trial data, a hypothetical cohort of CLBP patients transitioned over time among four defined health states: high-impact chronic pain with substantial activity limitations; higher (moderate-impact) and lower (low-impact) pain without activity limitations; and no pain. As patients transitioned among health states, they accumulated quality-adjusted life-years, as well as healthcare and productivity costs. Costs and effects were calculated incremental to each study's version of usual care.ResultsFrom the societal perspective and assuming a typical patient mix (25% low-impact, 35% moderate-impact, and 40% high-impact chronic pain), most interventions-including those newly added-were cost-effective (<$50,000/QALY) and demonstrated cost savings. From the payer perspective, fewer were cost-saving, but the same number were cost-effective. Results for the new studies generally mirrored others using the same interventions-for example, cognitive behavioral therapy (CBT) and physical therapy. A new acupuncture study had similar effectiveness to other acupuncture studies, but higher usual care costs, resulting in higher cost savings. Two new yoga studies' results were similar, but both differed from those of the original yoga study. Mindfulness-based stress reduction was similar to CBT for a typical patient mix but was twice as effective for those with high-impact chronic pain.ConclusionMarkov modeling facilitates comparisons across interventions not directly compared in trials, using consistent outcome measures after balancing the baseline mix of patients. Outcomes also differed by pain impact level, emphasizing the need to measure CLBP subgroups.Level of evidenceN/A.

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Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial.

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Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial.

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