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A feasibility randomised controlled trial of a Fibromyalgia self-management programme for adults in a community setting with a nested qualitative study (FALCON)

Pearson, Jennifer; Coggins, Jessica; Derham, Sandi; Russell, Julie; Walsh, Nicola E.; Lenguerrand, Erik; Palmer, Shea; Cramp, Fiona

A feasibility randomised controlled trial of a Fibromyalgia self-management programme for adults in a community setting with a nested qualitative study (FALCON) Thumbnail


Authors

Jen Pearson Jen.Pearson@uwe.ac.uk
Senior Lecturer in Physiotherapy (MSK and LTC)

Sandi Derham

Julie Russell

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Nicola Walsh Nicola.Walsh@uwe.ac.uk
Professor in Knowledge Mobilisation & Muscul

Erik Lenguerrand

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Shea Palmer Shea.Palmer@uwe.ac.uk
Occasional Associate Lecturer - CHSS - HSW

Fiona Cramp Fiona.Cramp@uwe.ac.uk
Professor in Long Term Conditions



Abstract

Background: Fibromyalgia is a condition associated with widespread musculoskeletal pain, fatigue and sleep problems. Fibromyalgia treatment guidelines recommend non-pharmacological interventions and the development of self-management skills. An example of a programme that fits these guidelines is the Fibromyalgia Self-management Programme (FSMP) which 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 FSMP in a community setting. Method: An 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. The Revised Fibromyalgia Impact Questionnaire, Arthritis Self-Efficacy Scale-8, Chalder Fatigue Scale, Short form 36, 5-Level EQ-5D version and Jenkins Sleep Scale were collected at baseline, 6 weeks and 6 months. Semi-structured interviews were conducted with patient participants, occupational therapists and physiotherapists to explore the acceptability and feasibility of delivering the FSMP 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 6 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: It is feasible to recruit people with fibromyalgia from Primary Care to participate in a randomised controlled trial testing the FSMP 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.

Citation

Pearson, J., Coggins, J., Derham, S., Russell, J., Walsh, N. E., Lenguerrand, E., …Cramp, F. (2022). A feasibility randomised controlled trial of a Fibromyalgia self-management programme for adults in a community setting with a nested qualitative study (FALCON). BMC Musculoskeletal Disorders, 23, Article 656. https://doi.org/10.1186/s12891-022-05529-w

Journal Article Type Article
Acceptance Date Mar 29, 2022
Online Publication Date Jul 11, 2022
Publication Date Jul 11, 2022
Deposit Date Mar 18, 2022
Publicly Available Date Jul 12, 2022
Journal BMC Musculoskeletal Disorders
Electronic ISSN 1471-2474
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 23
Article Number 656
DOI https://doi.org/10.1186/s12891-022-05529-w
Keywords Fibromyalgia, Feasibility randomised controlled trial, Self-management, Community
Public URL https://uwe-repository.worktribe.com/output/9212294

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A feasibility randomised controlled trial of a fibromyalgia self-management programme for adults in a community setting with a nested qualitative study (FALCON) (1.5 Mb)
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Copyright Statement
© The Author(s) 2022. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.





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