Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR)

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery

Rehabilitation following rotator cuff repair: A multi-centre pilot & feasibility randomised controlled trial (RaCeR)

Objective: To evaluate the feasibility of a multi-centre randomised controlled trial to compare the clinical and cost-effectiveness of early patient-directed rehabilitation versus standard rehabilitation following surgical repair of the rotator cuff of the shoulder. Design: Two-arm, multi-centre pilot and feasibility randomised controlled trial. Setting: Five National Health Service hospitals in England. Participants: Adults (n = 73) with non-traumatic rotator cuff tears scheduled for repair were recruited and randomly allocated remotely prior to surgery. Interventions: Early patient-directed rehabilitation (n = 37); advised to remove their sling as soon as able and move as symptoms allow. Standard rehabilitation (n = 36); sling immobilisation for four weeks. Measures: (1) Randomisation of 20% or more eligible patients. (2) Difference in time out of sling of 40% or more between groups. (3) Follow-up greater than 70%. Results: 73/185 (39%) potentially eligible patients were randomised. Twenty participants were withdrawn, 11 due to not receiving rotator cuff repair. The between-group difference in proportions of participants who exceeded the cut-off of 222.6 hours out of the sling was 50% (80% CI = 29%, 72%), with the early patient-directed rehabilitation group reporting greater time out of sling. 52/73 (71%) and 52/53 (98%) participants were followed-up at 12 weeks when withdrawals were included and excluded respectively. Eighteen full-thickness re-tears were reported (early patient-directed rehabilitation = 7, standard rehabilitation = 11). Five serious adverse events were reported. Conclusion: A main randomised controlled trial is feasible but would require allocation of participants following surgery to counter the issue of withdrawal due to not receiving surgery

Acute flares of knee osteoarthritis in primary care: a feasibility and pilot case-crossover study

Abstract Background Osteoarthritis (OA) is a leading cause of persistent pain and disability. Traditionally viewed as a slowly progressive disease, the impact of symptom variability on prognosis remains unclear. ‘Acute-on-chronic’ episodes are a well-recognised feature of many long-term conditions but only recently formally described in OA. This study aimed to develop a web-based data collection platform and establish key methodological design parameters, to develop a larger community-based study investigating acute flares of knee OA in England. Methods The study is a 9-week feasibility and pilot web-based observational case-crossover study. Adults aged ≥ 40 years registered with two general practices who had consulted their general practitioner for knee pain/OA in the last 2 years were recruited. Participants completed a baseline questionnaire and scheduled (control-period) questionnaires at follow-up weeks 1, 5, and 9. Participants were invited to self-declare via the website on any occasion they experienced a knee pain flare-up lasting ≥ 24 h. Upon notification, an event-driven (case-period) questionnaire comparable to the scheduled questionnaires was completed and daily measurements on the course and consequences were taken until resolution. A sub-study of 10 participants logged daily pain measurements. The analysis estimated key parameters including recruitment (selective non-participation, eligibility, consent), retention, and flare-up capture processes. Questionnaire completeness and website usability were evaluated. Results Of 442 patients invited, 14 completed baseline questionnaires. Eligibility rate was 26.9% (95% CI 19.3, 36.2), consent rate 53.6% (35.8, 70.5), and overall recruitment rate 3.2% (1.9, 5.2). Compared to those mailed, baseline responders were more likely to be male and ≥ 65 years, as were those reporting ≥ 1 flare-up. Eleven scheduled questionnaires were completed (mean response 35%). Although seven participants (50%) self-declared 11 flare-ups, only one event-driven questionnaire was completed and three participants contributed daily flare measurement for four flares. Missing data was ≤ 3.7% across completed baseline, scheduled, and event-driven questionnaires. Aspects of website usability require minor refinement. Conclusions Recruitment was not feasible with the current strategy. An evaluation of processes has suggested several substantial changes in design that may enhance recruitment, retention, and data quality in a future full-scale study

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

Introduction: Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients. Methods and analysis: A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted. Ethics and dissemination: This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy. Trial registration number: ISRCTN14736486

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care (SupportBack 2): a randomised controlled trial of clinical and cost-effectiveness

BackgroundLow back pain is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack).MethodsParticipants in UK primary care with low back pain without serious spinal pathology were randomly assigned 1:1:1 using computer algorithms stratified by disability level and telephone-support centre to usual care, usual care and SupportBack, or usual care and SupportBack with physiotherapist telephone-support (three brief calls). The primary outcome was low back pain-related disability (Roland Morris Disability Questionnaire [RMDQ] score) at 6 weeks, 3 months, 6 months, and 12 months using a repeated measures model, analysed by intention to treat using 97·5% CIs. A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of low back pain were involved in this trial from the outset. This completed trial was registered with ISRCTN, ISRCTN14736486.FindingsBetween Nov 29, 2018, and Jan 12, 2021, 825 participants were randomly assigned (274 to usual care, 275 to SupportBack only, 276 to SupportBack with telephone-support). Participants had a mean age of 54 (SD 15), 479 (58%) of 821 were women and 342 (42%) were men, and 591 (92%) of 641 were White. Follow-up rates were 687 (83%) at 6 weeks, 598 (73%) at 3 months, 589 (72%) at 6 months, and 652 (79%) at 12 months. For the primary analysis, 736 participants were analysed (249 usual care, 245 SupportBack, and 242 SupportBack with telephone support). At a significance level of 0·025, there was no difference in RMDQ over 12 months with SupportBack versus usual care (adjusted mean difference –0·5 [97·5% CI –1·2 to 0·2]; p=0·085) or SupportBack with telephone-support versus usual care (–0·6 [–1·2 to 0·1]; p=0·048). There were no treatment-related serious adverse events. The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a threshold of £20 000 per quality adjusted life year compared with usual care.InterpretationThe SupportBack internet interventions did not significantly reduce low back pain-related disability over 12 months compared with usual care. They were likely to be cost-effective and safe. Clinical effectiveness, cost-effectiveness, and safety should be considered together when determining whether to apply these interventions in clinical practice

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

Background Low back pain (LBP) is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack). Methods Participants in UK primary care with LBP without serious spinal pathology were block randomised using computer algorithms stratified by disability level and telephone-support centre to: 1) usual care, 2) usual care + SupportBack, 3) usual care + SupportBack + physiotherapist telephone-support (three brief calls). Primary outcome: LBP-related disability (Roland Morris Disability Questionnaire (RMDQ) at six weeks, three months, six months and 12 months using a repeated measures model, analysed by intention to treat using 97.5% Confidence Intervals (CIs). A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of LBP were involved in this trial and its reporting from the outset. Trial registration: ISRCTN14736486 Findings 825 participants were randomised (274 usual care, 275 SupportBack only, 276 SupportBack + telephone-support). Over half (58%) were female and 42% were male. Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months, and 79% at 12 months. For the primary analysis, 736 participants were analysed (respectively 249, 245, 242). Small reductions in RMDQ over 12 months compared to usual care occurred in the SupportBack group (adjusted mean difference -0.5, 97.5% CI -1.2 to 0.2, p=0.085) and SupportBack + telephone-support group (-0.6, 97.5% CI -1.2 to 0.1, p=0.048). These differences were not significant at a significance level of 0.025. There were no related Serious Adverse Events (SAEs). The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a QALY threshold of £20,000 compared to usual care. Interpretation The internet interventions did not significantly reduce LBP-related disability across 12 months compared to usual care. They were likely cost-effective and safe. Clinical effectiveness, cost-effectiveness and safety should be considered together when determining whether to apply these interventions in clinical practice. Funding This trial was funded by the NIHR HTA Programme (project 16/111/78)

Supporting self-management of low back pain with an internet intervention with and without telephone support in primary care: A randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

Background Low back pain (LBP) is prevalent and a leading cause of disability. We aimed to determine the clinical and cost-effectiveness of an accessible, scalable internet intervention for supporting behavioural self-management (SupportBack).Methods Participants in UK primary care with LBP without serious spinal pathology were block randomised using computer algorithms stratified by disability level and telephone-support centre to: 1) usual care, 2) usual care + SupportBack, 3) usual care + SupportBack + physiotherapist telephone-support (three brief calls). Primary outcome: LBP-related disability (Roland Morris Disability Questionnaire (RMDQ) at six weeks, three months, six months and 12 months using a repeated measures model, analysed by intention to treat using 97.5% Confidence Intervals (CIs). A parallel economic evaluation from a health services perspective was used to estimate cost-effectiveness. People with lived experience of LBP were involved in this trial and its reporting from the outset. Trial registration: ISRCTN14736486Findings 825 participants were randomised (274 usual care, 275 SupportBack only, 276 SupportBack + telephone-support). Over half (58%) were female and 42% were male. Follow-up rates were 83% at 6 weeks, 72% at 3 months, 70% at 6 months, and 79% at 12 months. For the primary analysis, 736 participants were analysed (respectively 249, 245, 242). Small reductions in RMDQ over 12 months compared to usual care occurred in the SupportBack group (adjusted mean difference -0.5, 97.5% CI -1.2 to 0.2, p=0.085) and SupportBack + telephone-support group (-0.6, 97.5% CI -1.2 to 0.1, p=0.048). These differences were not significant at a significance level of 0.025. There were no related Serious Adverse Events (SAEs). The economic evaluation showed that the SupportBack group dominated usual care, being both more effective and less costly. Both interventions were likely to be cost-effective at a QALY threshold of £20,000 compared to usual care.Interpretation The internet interventions did not significantly reduce LBP-related disability across 12 months compared to usual care. They were likely cost-effective and safe. Clinical effectiveness, cost-effectiveness and safety should be considered together when determining whether to apply these interventions in clinical practice.<br/

A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol

BackgroundGood quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person’s life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations.Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation.MethodsThe iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics.DiscussionThe iFraP trial will answer important questions about the effectiveness of the new ‘iFraP’ osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines.Trial registration: ISRCTN10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN1060640