The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain: a discrete choice experiment study.

OBJECTIVE: To identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). DESIGN: Discrete choice experiment. METHODS: The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email obtained from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS: Two-hundred and thirteen participants completed the survey. The mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. In the sensitivity analyses, the SWE varied with different levels of certainty calibration; from 0% without certainty calibration to 60% with more extreme certainty calibration. CONCLUSION: This patient-informed threshold of clinical importance could guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise.

Effectiveness and Cost-Effectiveness of a Stratified Blended Physiotherapy Intervention Compared With Face-to-Face Physiotherapy in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.

BACKGROUND: Nonspecific low back pain (LBP) is a leading contributor to disability worldwide, and its socioeconomic burden is substantial. Self-management support is an important recommendation in clinical guidelines for the physiotherapy treatment of patients with LBP and may support cost-effective management. However, providing adequate individually tailored self-management support is difficult. The integration of web-based applications into face-to-face care (ie, blended care) seems promising to optimize tailored treatment and enhance patients' self-management and, consequently, may reduce LBP-related costs. OBJECTIVE: We aimed to evaluate the long-term effectiveness and cost-effectiveness of stratified blended physiotherapy (e-Exercise LBP) compared with face-to-face physiotherapy in patients with nonspecific LBP. METHODS: An economic evaluation was conducted alongside a prospective, multicenter, cluster randomized controlled trial in primary care physiotherapy. Patients with nonspecific LBP were treated with either stratified blended physiotherapy (e-Exercise LBP) (n=104) or face-to-face physiotherapy (n=104). The content of both interventions was based on the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the STarT Back Screening Tool. The primary clinical outcome was physical functioning (Oswestry Disability Index version 2.1a). For the economic evaluation, quality-adjusted life years (QALYs; EQ-5D-5L) and physical functioning were the primary outcomes. Secondary clinical outcomes included fear avoidance beliefs and self-reported adherence. Costs were measured from societal and health care perspectives using self-report questionnaires. Effectiveness was estimated using linear mixed models. Seemingly unrelated regression analyses were conducted to estimate total cost and effect differences for the economic evaluation. RESULTS: Neither clinically relevant nor statistically substantial differences were found between stratified blended physiotherapy and face-to-face physiotherapy regarding physical functioning (mean difference [MD] -1.1, 95% CI -3.9 to 1.7) and QALYs (MD 0.026, 95% CI -0.020 to 0.072) over 12 months. Regarding the secondary outcomes, fear avoidance beliefs showed a statistically significant improvement in favor of stratified blended physiotherapy (MD -4.3, 95% CI -7.3 to -1.3). Societal and health care costs were higher for stratified blended physiotherapy than for face-to-face physiotherapy, but the differences were not statistically significant (societal: €972 [US $1027], 95% CI -€1090 to €3264 [US -$1151 to $3448]; health care: €73 [US $77], 95% CI -€59 to €225 [US -$62 to $238]). Among the disaggregated cost categories, only unpaid productivity costs were significantly higher for stratified blended physiotherapy. From both perspectives, a considerable amount of money must be paid per additional QALY or 1-point improvement in physical functioning to reach a relatively low to moderate probability (ie, 0.23-0.81) of stratified blended physiotherapy being cost-effective compared with face-to-face physiotherapy. CONCLUSIONS: The stratified blended physiotherapy intervention e-Exercise LBP is neither more effective for improving physical functioning nor more cost-effective from societal or health care perspectives compared with face-to-face physiotherapy for patients with nonspecific LBP. TRIAL REGISTRATION: ISRCTN 94074203; https://www.isrctn.com/ISRCTN94074203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12891-020-3174-z.

The smallest worthwhile effect on pain intensity of nonsteroidal anti-inflammatory drugs and exercise therapy for acute and chronic low back pain: a benefit-harm trade-off study.

QUESTION: What are the smallest worthwhile effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for people with acute and chronic low back pain (LBP)? What is the smallest worthwhile effect of individualised exercise for people with chronic LBP compared with no intervention? DESIGN: Benefit-harm trade-off study. PARTICIPANTS: Participants were recruited by advertisement on social media and included if they were English-speaking adults in Australia who had non-specific LBP. OUTCOME MEASURE: Pain intensity. RESULTS: A total of 116 people with acute LBP and 230 people with chronic LBP were recruited. For acute LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 30% (IQR 10 to 40%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 27.5% (IQR 10 to 50%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of exercise additional to no intervention was a 20% (IQR 10 to 40%) reduction in pain intensity. There were small associations between baseline pain, duration of pain and level of exercise and the smallest worthwhile effect of NSAIDs for acute LBP. There were no other clear associations. CONCLUSIONS: For people with LBP, the smallest worthwhile effect of exercise and NSAIDs additional to no intervention is approximately a 20 to 30% reduction in pain. These results can inform the interpretation of the effects of NSAIDs and exercise in randomised trials and meta-analyses, incorporating consumers' perspectives. Further research on comparisons between different interventions and on other core LBP outcomes may inform decision-making. REGISTRATION: OSF osf.io/3erjx/.

Minimal important change was on the lower spectrum of previous estimates and responsiveness was sufficient for core outcomes in chronic low back pain.

OBJECTIVES: The objective of this study was to estimate the minimal important change (MIC) and responsiveness of core patient reported outcome measures for chronic low back pain (LBP) and Modic changes. STUDY DESIGN AND SETTING: In the Antibiotics in Modic changes (AIM) trial we measured disability (RMDQ, ODI), LBP intensity (NRS) and health-related quality of life (EQ5D) electronically at baseline, three- and 12-month follow-up. MICs were estimated using Receiver Operating Curve (ROC) curve and Predictive modeling analyses against the global perceived effect. Credibility of the estimates was assessed by a standardized set of criteria. Responsiveness was assessed by a construct and criterion approach according to COSMIN guidelines. RESULTS: The MIC estimates of RMDQ, ODI and NRS scores varied between a 15-40% reduction, depending on including "slightly improved" in the definition of MIC or not. The MIC estimates for EQ5D were lower. The credibility of the estimates was moderate. For responsiveness, five out of six hypotheses were confirmed and AUC was >0.7 for all PROMs. CONCLUSION: When evaluated in a clinical trial of patients with chronic LBP and Modic changes, MIC thresholds for all PROMs were on the lower spectrum of previous estimates, varying depending on the definition of MIC. Responsiveness was sufficient.

Stratified exercise therapy does not improve outcomes compared with usual exercise therapy in people with knee osteoarthritis (OCTOPuS study): a cluster randomised trial.

QUESTION: In people with knee osteoarthritis, how much more effective is stratified exercise therapy that distinguishes three subgroups (high muscle strength subgroup, low muscle strength subgroup, obesity subgroup) in reducing knee pain and improving physical function than usual exercise therapy? DESIGN: Pragmatic cluster randomised controlled trial in a primary care setting. PARTICIPANTS: A total of 335 people with knee osteoarthritis: 153 in an experimental arm and 182 in a control arm. INTERVENTION: Physiotherapy practices were randomised into an experimental arm providing stratified exercise therapy (supplemented by a dietary intervention from a dietician for the obesity subgroup) or a control arm providing usual, non-stratified exercise therapy. OUTCOME MEASURES: Primary outcomes were knee pain severity (numerical rating scale for pain, 0 to 10) and physical function (Knee Injury and Osteoarthritis Outcome Score subscale activities of daily living, 0 to 100). Measurements were performed at baseline, 3 months (primary endpoint) and 6 and 12 months (follow-up). Intention-to-treat, multilevel, regression analysis was performed. RESULTS: Negligible differences were found between the experimental and control groups in knee pain (mean adjusted difference 0.2, 95% CI -0.4 to 0.7) and physical function (-0.8, 95% CI -4.3 to 2.6) at 3 months. Similar effects between groups were also found for each subgroup separately, as well as at other time points and for nearly all secondary outcome measures. CONCLUSION: This pragmatic trial demonstrated no added value regarding clinical outcomes of the model of stratified exercise therapy compared with usual exercise therapy. This could be attributed to the experimental arm therapists facing difficulty in effectively applying the model (especially in the obesity subgroup) and to elements of stratified exercise therapy possibly being applied in the control arm. REGISTRATION: Netherlands National Trial Register NL7463.

The 3-Month Effectiveness of a Stratified Blended Physiotherapy Intervention in Patients With Nonspecific Low Back Pain: Cluster Randomized Controlled Trial.

BACKGROUND: Patient education, home-based exercise therapy, and advice on returning to normal activities are established physiotherapeutic treatment options for patients with nonspecific low back pain (LBP). However, the effectiveness of physiotherapy interventions on health-related outcomes largely depends on patient self-management and adherence to exercise and physical activity recommendations. e-Exercise LBP is a recently developed stratified blended care intervention comprising a smartphone app integrated with face-to-face physiotherapy treatment. Following the promising effects of web-based applications on patients' self-management skills and adherence to exercise and physical activity recommendations, it is hypothesized that e-Exercise LBP will improve patients' physical functioning. OBJECTIVE: This study aims to investigate the short-term (3 months) effectiveness of stratified blended physiotherapy (e-Exercise LBP) on physical functioning in comparison with face-to-face physiotherapy in patients with nonspecific LBP. METHODS: The study design was a multicenter cluster randomized controlled trial with intention-to-treat analysis. Patients with nonspecific LBP aged ≥18 years were asked to participate in the study. The patients were treated with either stratified blended physiotherapy or face-to-face physiotherapy. Both interventions were conducted according to the Dutch physiotherapy guidelines for nonspecific LBP. Blended physiotherapy was stratified according to the patients' risk of developing persistent LBP using the Keele STarT Back Screening Tool. The primary outcome was physical functioning (Oswestry Disability Index, range 0-100). Secondary outcomes included pain intensity, fear-avoidance beliefs, and self-reported adherence. Measurements were taken at baseline and at the 3-month follow-up. RESULTS: Both the stratified blended physiotherapy group (104/208, 50%) and the face-to-face physiotherapy group (104/208, 50%) had improved clinically relevant and statistically significant physical functioning; however, there was no statistically significant or clinically relevant between-group difference (mean difference -1.96, 95% CI -4.47 to 0.55). For the secondary outcomes, stratified blended physiotherapy showed statistically significant between-group differences in fear-avoidance beliefs and self-reported adherence. In patients with a high risk of developing persistent LBP (13/208, 6.3%), stratified blended physiotherapy showed statistically significant between-group differences in physical functioning (mean difference -16.39, 95% CI -27.98 to -4.79) and several secondary outcomes. CONCLUSIONS: The stratified blended physiotherapy intervention e-Exercise LBP is not more effective than face-to-face physiotherapy in patients with nonspecific LBP in improving physical functioning in the short term. For both stratified blended physiotherapy and face-to-face physiotherapy, within-group improvements were clinically relevant. To be able to decide whether e-Exercise LBP should be implemented in daily physiotherapy practice, future research should focus on the long-term cost-effectiveness and determine which patients benefit most from stratified blended physiotherapy. TRIAL REGISTRATION: ISRCTN Registry 94074203; https://doi.org/10.1186/ISRCTN94074203. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s12891-020-3174-z.

The Transmural Trauma Care Model can be implemented well but some barriers and facilitators should be considered during implementation: a mixed methods study.

QUESTIONS: What is the reach, dose delivered, dose received and fidelity of the Transmural Trauma Care Model (TTCM)? What are the barriers and facilitators associated with the implementation of the TTCM? DESIGN: Mixed-methods process evaluation with quantitative evaluation of the extent to which the TTCM was implemented as intended and qualitative evaluation of barriers and facilitators to its implementation. PARTICIPANTS: Focus group participants included trauma patients, trauma surgeons, hospital-based physiotherapists and primary care network physiotherapists. OUTCOME MEASURES: Implementation was assessed with reach, dose delivered, dose received and fidelity. DATA ANALYSIS: A framework method was used to analyse the focus groups and the 'constellation approach' was used to categorise barriers and facilitators into three categories: structure, culture and practice. RESULTS: The TTCM's reach was 81%, its dose delivered was 99% and 100%, and its dose received was 95% and 96% for the multidisciplinary TTCM consultation hours at the outpatient clinic for trauma patients and the primary care network physiotherapists, respectively. Various fidelity scores ranged from 66 to 93%. Numerous barriers and facilitators associated with the implementation of the TTCM were identified and categorised. CONCLUSION: This process evaluation showed that the TTCM was largely implemented as intended. Furthermore, various facilitators and barriers were identified that need to be considered when implementing the TTCM more widely. Differences were found among stakeholders but they were generally of the opinion that if the barriers were overcome, the quality of care and patient satisfaction were likely to improve significantly after implementing the TTCM. REGISTRATION: NTR5474.

Cost-Effectiveness of the Transmural Trauma Care Model (TTCM) for the Rehabilitation of Trauma Patients.

OBJECTIVES: To assess the societal cost-effectiveness of the Transmural Trauma Care Model (TTCM), a multidisciplinary transmural rehabilitation model for trauma patients, compared with regular care. METHODS: The economic evaluation was performed alongside a before-and-after study, with a convenience control group measured only afterward, and a 9-month follow-up. Control group patients received regular care and were measured before implementation of the TTCM. Intervention group patients received the TTCM and were measured after its implementation. The primary outcome was generic health-related quality of life (HR-QOL). Secondary outcomes included disease-specific HR-QOL, pain, functional status, and perceived recovery. RESULTS: Eighty-three trauma patients were included in the intervention group and fifty-seven in the control group. Total societal costs were lower in the intervention group than in the control group, but not statistically significantly so (EUR-267; 95 percent confidence interval [CI], EUR-4,175-3011). At 9 months, there was no statistically significant between-group differences in generic HR-QOL (0.05;95 percent CI, -0.02-0.12) and perceived recovery (0.09;95 percent CI, -0.09-0.28). However, mean between-group differences were statistically significantly in favor of the intervention group for disease-specific HR-QOL (-8.2;95 percent CI, -15.0--1.4), pain (-0.84;95CI, -1.42--0.26), and functional status (-20.1;95 percent CI, -29.6--10.7). Cost-effectiveness acceptability curves indicated that if decision makers are not willing to pay anything per unit of effect gained, the TTCM has a 0.54-0.58 probability of being cost-effective compared with regular care. For all outcomes, this probability increased with increasing values of willingness-to-pay. CONCLUSIONS: The TTCM may be cost-effective compared with regular care, depending on the decision-makers willingness to pay and the probability of cost-effectiveness that they perceive as acceptable.

Behavioural treatment for chronic low-back pain.

BACKGROUND: Behavioural treatment is commonly used in the management of chronic low-back pain (CLBP) to reduce disability through modification of maladaptive pain behaviours and cognitive processes. Three behavioural approaches are generally distinguished: operant, cognitive, and respondent; but are often combined as a treatment package. OBJECTIVES: To determine the effects of behavioural therapy for CLBP and the most effective behavioural approach. SEARCH STRATEGY: The Cochrane Back Review Group Trials Register, CENTRAL, MEDLINE, EMBASE, and PsycINFO were searched up to February 2009. Reference lists and citations of identified trials and relevant systematic reviews were screened. SELECTION CRITERIA: Randomised trials on behavioural treatments for non-specific CLBP were included. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the risk of bias in each study and extracted the data. If sufficient homogeneity existed among studies in the pre-defined comparisons, a meta-analysis was performed. We determined the quality of the evidence for each comparison with the GRADE approach. MAIN RESULTS: We included 30 randomised trials (3438 participants) in this review, up 11 from the previous version. Fourteen trials (47%) had low risk of bias. For most comparisons, there was only low or very low quality evidence to support the results. There was moderate quality evidence that:i) operant therapy was more effective than waiting list (SMD -0.43; 95%CI -0.75 to -0.11) for short-term pain relief;ii) little or no difference exists between operant, cognitive, or combined behavioural therapy for short- to intermediate-term pain relief;iii) behavioural treatment was more effective than usual care for short-term pain relief (MD -5.18; 95%CI -9.79 to -0.57), but there were no differences in the intermediate- to long-term, or on functional status;iv) there was little or no difference between behavioural treatment and group exercise for pain relief or depressive symptoms over the intermediate- to long-term;v) adding behavioural therapy to inpatient rehabilitation was no more effective than inpatient rehabilitation alone. AUTHORS' CONCLUSIONS: For patients with CLBP, there is moderate quality evidence that in the short-term, operant therapy is more effective than waiting list and behavioural therapy is more effective than usual care for pain relief, but no specific type of behavioural therapy is more effective than another. In the intermediate- to long-term, there is little or no difference between behavioural therapy and group exercises for pain or depressive symptoms. Further research is likely to have an important impact on our confidence in the estimates of effect and may change the estimates.