Causal mechanisms of a healthy lifestyle intervention for patients with musculoskeletal pain who are overweight or obese.

PURPOSE: To assess the causal mechanisms of a healthy lifestyle intervention for patients with chronic low back pain and knee osteoarthritis, who are overweight or obese. METHODS: We conducted causal mediation analyses of aggregated data from two randomized controlled trials (RCTs); which included 160 patients with chronic low back pain, and 120 patients with knee osteoarthritis. The intervention consisted of brief advice and referral to a six-month telephone-based healthy lifestyle coaching service. We used causal mediation to estimate the indirect, direct and path-specific effects of hypothesized mediators including: self-reported weight, diet, physical activity, and pain beliefs. Outcomes were pain intensity, disability, and quality of life (QoL). RESULTS: The intervention did not reduce weight, improve diet or physical activity or change pain beliefs, and these mediators were not associated with the outcomes. Sensitivity analyses showed that our estimates were robust to the possible effects of unknown and unmeasured confounding. CONCLUSIONS: Our findings show that the intervention did not cause a meaningful change in the hypothesized mediators, and these mediators were not associated with patient-reported outcomes.

Economic evaluation of telephone-based weight loss support for patients with knee osteoarthritis: a randomised controlled trial.

BACKGROUND: The prevalence of knee osteoarthritis is increasing worldwide. Obesity is an important modifiable risk factor for both the incidence and progression of knee osteoarthritis. Consequently, international guidelines recommend all patients with knee osteoarthritis who are overweight receive support to lose weight. However, few overweight patients with this condition receive care to support weight loss. Telephone-based interventions are one potential solution to provide scalable care to the many patients with knee osteoarthritis. The objective of this study is to evaluate, from a societal perspective, the cost-utility and cost-effectiveness of a telephone-based weight management and healthy lifestyle service for patients with knee osteoarthritis, who are overweight or obese. METHODS: An economic evaluation was undertaken alongside a pragmatic randomised controlled trial. Between May 19 and June 30, 2015, 120 patients with knee osteoarthritis were randomly assigned to an intervention or usual care control group in a 1:1 ratio. Participants in the intervention group received a referral to an existing non-disease specific 6-month telephone-based weight management and healthy lifestyle service. Quality-adjusted life years (QALYs) was the utility measure and knee pain intensity, disability, weight, and body mass index (BMI) were the clinical measures of effect. Costs included intervention costs, healthcare utilisation costs (healthcare services and medication use) and absenteeism costs due to knee pain. Data was collected at baseline, 6 weeks and 26 weeks. The primary cost-effectiveness analysis was performed from the societal perspective. RESULTS: Mean cost differences between groups (intervention minus control) were $493 (95%CI: -3513 to 5363) for healthcare costs, $-32 (95%CI: -73 to 13) for medication costs, and $125 (95%CI: -151 to 486) for absenteeism costs. The total mean difference in societal costs was $1197 (95%CI: -2887 to 6106). For QALYs and all clinical measures of effect, the probability of the intervention being cost-effective compared with usual care was less than 0.36 at all willingness-to-pay values. CONCLUSIONS: From a societal perspective, telephone-based weight loss support, provided using an existing non-disease specific 6-month weight management and healthy lifestyle service was not cost-effective in comparison with usual care for overweight and obese patients with knee osteoarthritis. TRIAL REGISTRATION NUMBER: ACTRN12615000490572 , registered 18th May 2015.

Effectiveness of Weight-Loss Interventions for Reducing Pain and Disability in People With Common Musculoskeletal Disorders: A Systematic Review With Meta-Analysis.

OBJECTIVE: To assess the effectiveness of weight-loss interventions on pain and disability in people with knee and hip osteoarthritis (OA) and spinal pain. DESIGN: Intervention systematic review. LITERATURE SEARCH: Twelve online databases and clinical trial registries. STUDY SELECTION CRITERIA: Randomized controlled trials of any weight-loss intervention (eg, diet, physical activity, surgical, pharmaceutical) that reported pain or disability outcomes in people with knee or hip OA or spinal pain. DATA SYNTHESIS: We calculated mean differences or standardized mean differences (SMDs) and 95% confidence intervals (CIs). We used the Cochrane risk of bias tool to assess risk of bias and the Grading of Recommendations Assessment, Development, and Evaluation tool to judge credibility of evidence. RESULTS: Twenty-two trials with 3602 participants were included. There was very low- to very low-credibility evidence for a moderate effect of weight-loss interventions on pain intensity (10 trials, n = 1806; SMD, -0.54; 95% CI: -0.86, -0.22; I2 = 87%, P<.001) and a small effect on disability (11 trials, n = 1821; SMD, -0.32; 95% CI: -0.49, -0.14; I2 = 58%, P<.001) compared to minimal care for people with OA. For knee OA, there was low- to moderate-credibility evidence that weight-loss interventions were not more effective than exercise only for pain intensity and disability, respectively (4 trials, n = 673; SMD, -0.13; 95% CI: -0.40, 0.14; I2 = 55%; 5 trials, n = 737; SMD, -0.20; 95% CI: -0.41, 0.00; I2 = 32%). CONCLUSION: Weight-loss interventions may provide small to moderate improvements in pain and disability for OA compared to minimal care. There was limited and inconclusive evidence for weight-loss interventions targeting spinal pain. J Orthop Sports Phys Ther 2020;50(6):319-333. Epub 9 Apr 2020. doi:10.2519/jospt.2020.9041.

Healthy Lifestyle Program (HeLP) for low back pain: protocol for a randomised controlled trial.

INTRODUCTION: Low back pain is one of the most common and burdensome chronic conditions worldwide. Lifestyle factors, such as excess weight, physical inactivity, poor diet and smoking, are linked to low back pain chronicity and disability. There are few high-quality randomised controlled trials that investigate the effects of targeting lifestyle risk factors in people with chronic low back pain. METHODS AND ANALYSIS: The aim of this study is to determine the effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain targeting weight, physical activity, diet and smoking to reduce disability in patients with chronic low back pain compared with usual care. This is a randomised controlled trial, with participants stratified by body mass index, allocated 1:1 to the HeLP intervention or usual physiotherapy care. HeLP involves three main components: (1) clinical consultations with a physiotherapist and dietitian; (2) educational resources; and (3) telephone-based health coaching support for lifestyle risk factors. The primary outcome is disability (Roland Morris Disability Questionnaire) at 26 weeks. Secondary outcomes include pain intensity, weight, quality of life and smoking status. Data will be collected at baseline, and at weeks 6, 12, 26 and 52. Patients with chronic low back pain who have at least one health risk factor (are overweight or obese, are smokers and have inadequate physical activity or fruit and vegetable consumption) will be recruited from primary or secondary care, or the community. Primary outcome data will be analysed by intention to treat using linear mixed-effects regression models. We will conduct three supplementary analyses: causal mediation analysis, complier average causal effects analysis and economic analysis. ETHICS AND DISSEMINATION: This study was approved by the Hunter New England Research Ethics Committee (Approval No 17/02/15/4.05), and the University of Newcastle Human Research Ethics Committee (Ref No H-2017-0222). Outcomes of this trial and supplementary analyses will be disseminated through publications in peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: ACTRN12617001288314.

Economic evaluation of a healthy lifestyle intervention for chronic low back pain: A randomized controlled trial.

BACKGROUND: Economic evaluations which estimate cost-effectiveness of potential treatments can guide decisions about real-world healthcare services. We performed an economic evaluation of a healthy lifestyle intervention targeting weight loss, physical activity and diet for patients with chronic low back pain, who are overweight or obese. METHODS: Eligible patients with chronic low back pain (n = 160) were randomized to an intervention or usual care control group. The intervention included brief advice, a clinical consultation and referral to a 6-month telephone-based healthy lifestyle coaching service. The primary outcome was quality-adjusted life years (QALYs). Secondary outcomes were pain intensity, disability, weight and body mass index. Costs included intervention costs, healthcare utilization costs and work absenteeism costs. An economic analysis was performed from the societal perspective. RESULTS: Mean total costs were lower in the intervention group than the control group (-$614; 95%CI: -3133 to 255). The intervention group had significantly lower healthcare costs (-$292; 95%CI: -872 to -33), medication costs (-$30; 95%CI: -65 to -4) and absenteeism costs (-$1,000; 95%CI: -3573 to -210). For all outcomes, the intervention was on average less expensive and more effective than usual care, and the probability of the intervention being cost-effective compared to usual care was relatively high (i.e., 0.81) at a willingness-to-pay of $0/unit of effect. However, the probability of cost-effectiveness was not as favourable among sensitivity analyses. CONCLUSIONS: The healthy lifestyle intervention seems to be cost-effective from the societal perspective. However, variability in the sensitivity analyses indicates caution is needed when interpreting these findings. SIGNIFICANCE: This is an economic evaluation of a randomized controlled trial of a healthy lifestyle intervention for chronic low back pain. The findings suggest that a healthy lifestyle intervention may be cost-effective relative to usual care.

Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

Mechanism evaluation of a lifestyle intervention for patients with musculoskeletal pain who are overweight or obese: protocol for a causal mediation analysis.

INTRODUCTION: Low back pain (LBP) and knee osteoarthritis (OA) are highly prevalent and disabling conditions that cause societal and economic impact worldwide. Two randomised controlled trials (RCTs) will evaluate the effectiveness of a multicomponent lifestyle intervention for patients with LBP and knee OA who are overweight or obese. The key targets of this intervention are to improve physical activity, modify diet and correct pain beliefs. These factors may explain how a lifestyle intervention exerts its effects on key patient-relevant outcomes: pain, disability and quality of life. The aim of this protocol is to describe a planned analysis of a mechanism evaluation for a lifestyle intervention for overweight or obese patients with LBP and knee OA. METHODS AND ANALYSIS: Causal mediation analyses of 2 two-armed RCTs. Both trials are part of a cohort-multiple RCT, embedded in routine health service delivery. In each respective trial, 160 patients with LBP and 120 patients with knee OA waiting for orthopaedic consultation will be randomised to a lifestyle intervention, or to remain part of the original cohort. The intervention consists of education and advice about the benefits of weight loss and physical activity, and the Australian New South Wales Get Healthy Service. All outcome measures including patient characteristics, primary and alternative mediators, outcomes, and potential confounders will be measured at baseline (T0). The primary mediator, weight, will be measured at 6 months post randomisation; alternative mediators including diet, physical activity and pain beliefs will be measured at 6 weeks post randomisation. All outcomes (pain, disability and quality of life) will be measured at 6 months post randomisation. Data will be analysed using causal mediation analysis with sensitivity analyses for sequential ignorability. All mediation models were specified a priori before completing data collection and without prior knowledge about the effectiveness of the intervention. ETHICS AND DISSEMINATION: The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000490572 and ACTRN12615000478516; Pre-results.

Randomised controlled trial of referral to a telephone-based weight management and healthy lifestyle programme for patients with knee osteoarthritis who are overweight or obese: a study protocol.

INTRODUCTION: Knee osteoarthritis (OA) is one of the most common chronic diseases worldwide and is associated with significant pain and disability. Clinical practice guidelines consistently recommend weight management as a core aspect of care for overweight and obese patients with knee OA; however, provision of such care is suboptimal. Telephone-based interventions offer a novel approach to delivery of weight management care in these patients. The aim of the proposed study is to assess the effectiveness of referral to a telephone-based weight management and healthy lifestyle programme, previously shown to be effective in changing weight, in improving knee pain intensity in overweight or obese patients with knee OA, compared to usual care. METHODS AND ANALYSIS: A parallel, randomised controlled trial will be undertaken. Patients with OA of the knee who are waiting for an outpatient orthopaedic consultation at a tertiary referral public hospital within New South Wales, Australia, will be allocated to either an intervention or a control group (1:1 ratio). After baseline data collection, patients in the intervention group will receive a 6-month telephone-based intervention, and patients in the control group will continue with usual care. Surveys will be conducted at baseline, 6 and 26 weeks post-randomisation. The study requires 60 participants per group to detect a two-point difference in pain intensity (primary outcome) 26 weeks after baseline. ETHICS AND DISSEMINATION: The study is approved by the Hunter New England Health Human Research Ethics Committee (13/12/11/5.18) and the University of Newcastle Human Research Ethics Committee (H-2015-0043). The results will be disseminated in peer-reviewed journals and at scientific conferences. TRIAL REGISTRATION NUMBER: ACTRN12615000490572, Pre-results.