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)

Abstract

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 Fourteen 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). One hundred twenty 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 physiotherapists (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 ISRCTN49875385. Registered on 26 March 2014.

Contexts, behavioural mechanisms and outcomes to optimise therapeutic exercise prescription for persistent low back pain: a realist review

“…Twenty-two of the 75 included studies comprised qualitative research designs (12 patient perspective31 41–51; 5 physiotherapist perspective52–56; 5 mixed perspectives57–61), followed by quantitative designs (n=15) (longitudinal cohort studies n=11,22 62–71 secondary analysis of RCTs n=472–75), RCTs (n=15),76–90 systematic reviews (n=15),21 32 47 91–102 mixed methods (n=3),30 103 104 commentary (n=2),105 106 case reports (n=2)107 108 and narrative reviews (n=1) 109. See online supplement 4) for details of included studies and their quality appraisal.…”

Using self‐determination theory in research and evaluation in primary care

“…In the first study, Hurley et al 32 , 33 , 34 , 35 have published four papers from their study on ‘Self‐management of Osteoarthritis and Low back pain through Activity and Skills’ (SOLAS), which was a theory‐driven complex SDT intervention of self‐management of osteoarthritis and low back pain in primary care. This included a protocol for their cluster RCT feasibility trial, 32 intervention development, 33 views of the physiotherapists who delivered the intervention on the training programme 34 and the findings of the cluster RCT feasibility trial, 35 which found the intervention to be acceptable, with small improvements in some secondary outcomes at 2 and 6 months. However, recruitment of primary care centres and patients was problematic and the authors concluded that progression to a definitive trial would not be feasible.…”

“…However, recruitment of primary care centres and patients was problematic and the authors concluded that progression to a definitive trial would not be feasible. 35 In this study, the authors used a theoretical domains framework to consider a range of behaviour change theories in the intervention mapping activities, before selecting SDT. 33 …”

The Web-Based Pain-at-Work Toolkit With Telephone Support for Employees With Chronic or Persistent Pain: Protocol for a Cluster Randomized Feasibility Trial

“…A formal sample size calculation is not required for feasibility studies, although based on prior studies with a similar design [94][95][96], our aim is to recruit 120 employees from at least 8 organizations. Given the variability in organization size, if 120 employees are not recruited from 8 organizations, additional organizations may be recruited.…”