A feasibility Randomised Controlled Trial of a Fibromyalgia Self-management Programme in a community setting with a nested qualitative study (FALCON)

Background Fibromyalgia is a condition associated with widespread musculoskeletal pain, fatigue and sleep problems. Fibroymyaglia treatment guidelines recommend non-pharmacological interventions and the development of self-management skills. The Fibromyalgia Self-management Programme (FSMP) consists of one 2.5-hour weekly session over six successive weeks and includes education about fibromyalgia, goal setting, pacing, sleep hygiene and nutritional advice. The FSMP is currently provided in a secondary care hospital setting and co-delivered by a multidisciplinary team. Delivery in a primary care setting has the potential to improve the accessibility of the programme to people with fibromyalgia. Therefore, this feasibility study aimed to determine the practicality and acceptability of conducting a future definitive randomised controlled trial of the FMSP in a community setting.MethodAn exploratory, parallel-arm, one-to-one, randomised controlled trial. Participants were recruited from general practices across South West England, and the FSMP was co-delivered by physiotherapists and occupational therapists across two community sites. To determine the outcome measures for a future definitive trial several were tested. All clinical outcome measures were patient-reported and collected at baseline, six weeks and six months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FMSP in a community setting.Results A total of 74 participants were randomised to the FSMP intervention (n=38) or control arm (n=36). Attrition from the trial was 42% (31/74) at six months. A large proportion of those randomised to the intervention arm (34%, 13/38) failed to attend any sessions with six of the 13 withdrawing before the intervention commenced. The proportion of missing values was small for each of the outcome measures. Three overarching themes were derived from the interview data; (1) barriers and facilitators to attending the FSMP; (2) FSMP content, delivery and supporting documentation; and (3) trial processes.Conclusion Findings indicate that it is feasible to recruit people with fibromyalgia from primary care to participate in a randomised controlled trial testing the clinical and cost-effectiveness of the FSMP delivered in a community setting. However, improvement in trial attrition and engagement with the intervention is needed. Trial registration: The trial is registered with ISRCTN registry and was assigned on 29/04/2019. The registration number is ISRCTN10824225.