Abstract
BackgroundThe 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.MethodsThis 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.ResultsFourteen 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.ConclusionsWhile 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 registrationISRCTN ISRCTN49875385. Registered on 26 March 2014.
Highlights
The successful implementation of a standardised, evidence-based group programme to support selfmanagement (SM) for people with chronic musculoskeletal pain is a priority for primary care physiotherapy (PT) in Ireland [1]
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
We developed the self-management of OA and chronic low back pain (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]
Summary
The successful implementation of a standardised, evidence-based group programme to support selfmanagement (SM) for people with chronic musculoskeletal pain is a priority for primary care physiotherapy (PT) in Ireland [1]. The IM process included a needs assessment involving literature reviews, interviews with patients with OA and LBP and primary care physiotherapists, evaluation of existing primary care physiotherapy resources to provide a standardised group programme, and a consensus building workshop with physiotherapy stakeholders to define the SOLAS intervention programme goals, underpinning behaviour change theory and required adaptations to FASA to address the needs of patients, the health service and the evidence [13]. 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
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