Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS)

Abstract

IntroductionInternational clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources.Methods/analysisThis protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial.Ethics/disseminationThis feasibility trial protocol was approved by the UCD Human Research Ethics—Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences.Trial registration numberISRCTN 49875385; Pre-results.

An assessment of physiotherapist’s delivery of behaviour change techniques within the SOLAS feasibility trial

“…Chronic musculoskeletal pain (CMP) is a common cause of disability, placing significant burdens on health care systems (Cimmino, Ferrone, & Cutolo, ; Dziedzic, French, Davis, Geelhoed, & Porcheret, ; Hurley, Murphy, Pincus , et al ., ; NICE, ; Palazzo, Ravaud, Papelard, Ravaud, & Poiraudeau, ). Self‐management is an endorsed CMP treatment approach that includes enhancing participants’ understanding of their condition and supporting positive health behaviours such as physical activity (PA) and weight management (NICE, , ).…”

Evaluation of an E-Learning Training Program to Support Implementation of a Group-Based, Theory-Driven, Self-Management Intervention For Osteoarthritis and Low-Back Pain: Pre-Post Study (Preprint)

“…At the end of the training period, participants were invited to set up and deliver the SOLAS intervention according to the treatment protocol [10] in each of their primary care areas, i.e. one intervention per area.…”

“…The content is based on the face to face training program developed for the SOLAS feasibility trial [10,14]. The E-SOLAS program is hosted on Curatr (http://www.curatr3.com/), an online social learning platform that creates a collaborative learning environment and uses gamification principles.…”

“…The Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention is an evidencesupported group treatment approach, developed through the intervention mapping process [9], and evaluated for its acceptability and feasibility compared to individual physiotherapy in the SOLAS feasibility trial [10]. Intervention physiotherapists (PTs) within the trial were trained using brief interactive lectures, videos, role play and practical skills to deliver the SOLAS intervention in a needs supportive manner, underpinned by self-determination theory (SDT).…”

“…They were encouraged to complete the training over a 4-week period working at their own pace and at times that were convenient for them. During training they had access to ongoing technical support from the research team and were requested to keep a log of the time spent on each aspect of training.At the end of the training period, participants were invited to set up and deliver the SOLAS intervention according to the treatment protocol [10] in each of their primary care areas, i.e. one intervention per area.…”