Exercise and self-management for people with chronic knee, hip or lower back pain: a cluster randomised controlled trial of clinical and cost-effectiveness. Study protocol

Walsh, Nicola; Cramp, Fiona; Palmer, Shea; Pollock, Jon; Hampson, Lisa V.; Gooberman‐Hill, Rachael; Green, Colin; Jones, Louise; Phillips, Sonia; Johnson, Liz; Hurley, Mike

doi:10.1016/j.physio.2012.09.002

Cited by 21 publications

(20 citation statements)

References 22 publications

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“…62 We are also currently investigating its adaptation and application to a wider population of patients with chronic knee, hip and lower back pain in a cluster RCT. 63 The general approach is to help patients to become more physically active through developing the knowledge, understanding and skills to better manage their condition. This is achieved through a process of education, problem-solving, reflection and planning, along with gaining experience of exercise and learning from accomplishments.…”

Section: Development Of the Physiotherapy Interventionmentioning

confidence: 99%

The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome

Palmer

Cramp

Clark

et al. 2016

Health Technol Assess

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BackgroundJoint hypermobility syndrome (JHS) is a heritable disorder associated with laxity and pain in multiple joints. Physiotherapy is the mainstay of treatment, but there is little research investigating its clinical effectiveness.ObjectivesTo develop a comprehensive physiotherapy intervention for adults with JHS; to pilot the intervention; and to conduct a pilot randomised controlled trial (RCT) to determine the feasibility of conducting a future definitive RCT.DesignPatients’ and health professionals’ perspectives on physiotherapy for JHS were explored in focus groups (stage 1). A working group of patient research partners, clinicians and researchers used this information to develop the physiotherapy intervention. This was piloted and refined on the basis of patients’ and physiotherapists’ feedback (stage 2). A parallel two-arm pilot RCT compared ‘advice’ with ‘advice and physiotherapy’ (stage 3). Random allocation was via an automated randomisation service, devised specifically for the study. Owing to the nature of the interventions, it was not possible to blind clinicians or patients to treatment allocation.SettingStage 1 – focus groups were conducted in four UK locations. Stages 2 and 3 – piloting of the intervention and the pilot RCT were conducted in two UK secondary care NHS trusts.ParticipantsStage 1 – patient focus group participants (n = 25, three men) were aged > 18 years, had a JHS diagnosis and had received physiotherapy within the preceding 12 months. The health professional focus group participants (n = 16, three men; 14 physiotherapists, two podiatrists) had experience of managing JHS. Stage 2 – patient participants (n = 8) were aged > 18 years, had a JHS diagnosis and no other musculoskeletal conditions causing pain. Stage 3 – patient participants for the pilot RCT (n = 29) were as for stage 2 but the lower age limit was 16 years.InterventionFor the pilot RCT (stage 3) the advice intervention was a one-off session, supplemented by advice booklets. All participants could ask questions specific to their circumstances and receive tailored advice. Participants were randomly allocated to ‘advice’ (no further advice or physiotherapy) or ‘advice and physiotherapy’ (an additional six 30-minute sessions over 4 months). The physiotherapy intervention was supported by a patient handbook and was delivered on a one-to-one patient–therapist basis. It aimed to increase patients’ physical activity through developing knowledge, understanding and skills to better manage their condition.Main outcome measuresData from patient and health professional focus groups formed the main outcome from stage 1. Patient and physiotherapist interview data also formed a major component of stages 2 and 3. The primary outcome in stage 3 related to the feasibility of a future definitive RCT [number of referrals, recruitment and retention rates, and an estimate of the value of information (VOI) of a future RCT]. Secondary outcomes included clinical measures (physical function, pain, global status, self-reported joint count, quality of life, exercise self-efficacy and adverse events) and resource use (to estimate cost-effectiveness). Outcomes were recorded at baseline, 4 months and 7 months.ResultsStage 1 – JHS is complex and unpredictable. Physiotherapists should take a long-term holistic approach rather than treating acutely painful joints in isolation. Stage 2 – a user-informed physiotherapy intervention was developed and evaluated positively. Stage 3 – recruitment to the pilot RCT was challenging, primarily because of a perceived lack of equipoise between advice and physiotherapy. The qualitative evaluation provided very clear guidance to inform a future RCT, including enhancement of the advice intervention. Some patients reported that the advice intervention was useful and the physiotherapy intervention was again evaluated very positively. The rate of return of questionnaires was low in the advice group but reasonable in the physiotherapy group. The physiotherapy intervention showed evidence of promise in terms of primary and secondary clinical outcomes. The advice arm experienced more adverse events. The VOI analysis indicated the potential for high value from a future RCT. Such a trial should form the basis of future research efforts.ConclusionA future definitive RCT of physiotherapy for JHS seems feasible, although the advice intervention should be made more robust to address perceived equipoise and subsequent attrition.Trial registrationCurrent Controlled Trials ISRCTN29874209.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 47. See the NIHR Journals Library website for further project information.

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Section: Development Of the Physiotherapy Interventionmentioning

confidence: 99%

The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome

Palmer

Cramp

Clark

et al. 2016

Health Technol Assess

Self Cite

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“…Furthermore, the recruitment protocol successfully enrolled participants with OA of the hip, knee, lumbar spine and CLBP, with the latter being the most prevalent in line with population data. In contrast to the FASA intervention, which restricted recruitment to individuals with OA aged at least 50 years [12], our ndings have demonstrated the feasibility of enrolling and retaining younger participants with CLBP to a group-based programme alongside older people with OA. Nonetheless, the average cluster size of ve participants in both arms, the average class size of four participants and the overall recruitment rate were below the target of 144 required to demonstrate feasibility, but enough for a sample size calculation for a de nitive trial as discussed below.…”

Section: Feasibility: Trial Recruitment Retention and Follow-up Procmentioning

confidence: 67%

“…Additional local barriers to implementation of these guidelines in Ireland include the variable quality of the primary care health system infrastructure and physiotherapy sta ng levels, resulting in most patients with OA and LBP receiving a plethora of multi-modal individual physiotherapy approaches from staff with varying levels of expertise in chronic musculoskeletal pain [1]. We developed the Self-management of OA and chronic LBP through Activity and Skills (SOLAS) complex intervention, by adapting an existing intervention (Facilitating Activity and Self-management in Arthritis, FASA) [12] through an intervention mapping (IM) process [13]. FASA is a version of the e cacious and cost effective ESCAPE-knee pain intervention [14,15] designed for patients with OA of the hip, knee and lumbar spine with proven acceptability in the UK health system [16], and hence it was considered a credible prototype for adaptation.…”

Section: Introductionmentioning

confidence: 99%

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

Hurley

Jeffares

Hall

et al. 2020

Preprint

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Background: The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods: This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results: 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects.Conclusions: While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial.Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

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“…Additional local barriers to implementation of these guidelines in Ireland include the variable quality of the primary care health system infrastructure and physiotherapy staffing levels, resulting in most patients with OA and LBP receiving a plethora of multimodal individual physiotherapy approaches from staff with varying levels of expertise in chronic musculoskeletal pain [1]. We developed the Self-management of OA and chronic LBP through Activity and Skills (SOLAS) complex intervention, by adapting an existing intervention (Facilitating Activity and Self-management in Arthritis, FASA) [12] through an intervention mapping (IM) process [13]. FASA is a version of the efficacious and cost effective ESCAPE-knee pain intervention [14,15] designed for patients with OA of the hip, knee and lumbar spine with proven acceptability in the UK health system [16], and hence it was considered a credible prototype for adaptation.…”

Section: Introductionmentioning

confidence: 99%

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

Hurley

Jeffares

Hall

et al. 2020

Preprint

View full text Add to dashboard Cite

Background The Self-management of Osteoarthritis (OA) and Low back pain (LBP) through Activity and Skills (SOLAS) theory-driven group-based complex intervention was developed primarily for the evaluation of its acceptability to patients and physiotherapists and the feasibility of trial procedures, to inform the potential for a definitive trial. Methods This assessor-blinded multicentre two-arm parallel cluster randomised controlled feasibility trial compared the SOLAS intervention to usual individual physiotherapy (UP; pragmatic control group). Patients with OA of the hip, knee, lumbar spine and/or chronic LBP were recruited in primary care physiotherapy clinics (i.e. clusters) in Dublin, Ireland between September 2014 and November 2015. The primary feasibility objectives were evaluated using quantitative methods and individual telephone interviews with purposive samples of participants and physiotherapists. A range of secondary outcomes were collected at baseline, 6 weeks (behaviour change only), 2 months and 6 months to explore the preliminary effects of the intervention. Analysis was by intention-to-treat according to participants’ cluster allocation and involved descriptive analysis of the quantitative data and inductive thematic analysis of the qualitative interviews. A linear mixed model was used to contrast change over time in participant secondary outcomes between treatment arms, while adjusting for study waves and clusters. Results 14 clusters were recruited (7 per trial arm), each cluster participated in two waves of recruitment, with the average cluster size below the target of six participants (Intervention: mean (SD) =4.92 (1.31), range 2-7; UP: mean (SD) =5.08 (2.43), range 1-9). 120 participants (83.3% of n=144 expected) were recruited (Intervention n=59; UP n=61), with follow up data obtained from 80.8% (n=97) at 6 weeks, 84.2% (n=101) at 2 months and 71.7% (n=86) at 6 months. Most participants received treatment as allocated (Intervention n=49; UP n=54). The qualitative interviews (12 participants; 10 PTs) found the Intervention and trial procedures acceptable and appropriate, with minimal feasible adaptations required. Linear mixed methods showed improvements in most secondary outcomes at 2 and 6 months with small between group effects. Conclusions While the SOLAS intervention and trial procedures were acceptable to participants and PTs, the recruitment of enough participants is the biggest obstacle to a definitive trial. Trial Registration: ISRCTN Registry, ISRCTN49875385, Registered 26 March 2014. https://doi.org/10.1186/ISRCTN49875385

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Exercise and self-management for people with chronic knee, hip or lower back pain: a cluster randomised controlled trial of clinical and cost-effectiveness. Study protocol

Cited by 21 publications

References 22 publications

The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome

The feasibility of a randomised controlled trial of physiotherapy for adults with joint hypermobility syndrome

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

Feasibility cluster randomised controlled trial evaluating a theory-driven group-based complex intervention versus usual physiotherapy to support self-management of osteoarthritis and low back pain (SOLAS)

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