Fibromyalgia community self-management feasibility trial

Plain English summary of protocol

Background and study aims
Fibromyalgia (FM) is a complex long-term condition affecting up to 5.4% of the UK population. It is associated with chronic widespread pain, fatigue, stiffness, sleep problems, memory and concentration difficulties, and irritable bowel syndrome. FM can cause high levels of disability, with individuals making frequent use of healthcare resources and experiencing loss of workdays. There is limited robust evidence for the effectiveness of drug treatments for FM. Current guidelines for the treatment of FM all recommend non-drug treatments, of which cognitive behaviour therapy (CBT), aerobic exercise, hydrotherapy, relaxation and patient education are the best evidenced. In combination with the drug and non-drug treatments to treat FM, a common patient goal is to develop the skills needed to independently self-manage their condition. The evidence for self- management interventions are compelling and have been shown to improve both physical symptoms and function, participant engagement, self-efficacy, mood, and reduce health service costs in a number of long-term conditions. Previous research on FM self-management within a community setting found short-term improvement in severity of FM symptoms, improvement in self-efficacy to manage symptoms of pain, decreased fatigue and a reduction in GP FM-related contacts.
Allied health professionals at the Royal National Hospital for Rheumatic Diseases, Royal United Hospitals Bath NHS Foundation Trust (RUHB), have designed the Fibromyalgia Self-Management Programme (FSMP), a non-drug, multidisciplinary exercise and education group intervention. The main aims of the FSMP are to provide condition-specific patient-centred education and exercise advice, supporting the development of core self- management skills for those affected by FM. The FSMP comprises one 2.5-hour weekly session over six consecutive weeks. Core components include education about FM, sleep hygiene, goal setting, pacing, hydrotherapy, and dietary advice. Local audits suggest that the FSMP improves patients’ self-efficacy in managing FM symptoms, reduces healthcare utilisation costs and has high levels of patient satisfaction.
To date, the delivery of the FSMP has been within an acute hospital setting by a team of specialist Rheumatology occupational therapists and physiotherapists. However, recent government plans recommended that the care of adults affected by long-term conditions is transferred from acute hospital environments to the community. Transferring the delivery of FSMP to a community setting presents an opportunity to determine the clinical and cost effectiveness of the programme. It is also possible that the programme and training of healthcare professionals will need to be modified for delivery in the community. For example, Band 6/7 non-specialist therapists delivering the programme may not have a rheumatology background and are likely to have additional training needs.
The aim of this feasibility study is to determine the practicality and acceptability of conducting a full trial to deliver the FSMP in the community.

Who can participate?
Adults aged 18 and over with FM

What does the study involve?
Participants are randomly allocated to either the FSMP or the GP management group (control group). Those in the GP management group continue under the normal care of their GP, but are asked to complete the questionnaires. Those in the education programme group attend six education classes over a six-week period. Each class is run by a physiotherapist and occupational therapist, consists of 8-12 people and lasts for about 2.5 hours. During this time they participate in education sessions which may help them to manage their fibromyalgia. The classes consist of information about FM and chronic pain, pacing activities, sleep, medication, relaxation, diet and exercise. They also receive information on how to set goals, plan activities and participate in optional gentle exercise sessions.

What are the possible benefits and risks of participating?
Participants may be at risk of increased fatigue after the sessions, but as this is self-management intervention the risk to patients is low. The clinical teams at the RUHB have been delivering the FSMP intervention for over 10 years and are not aware of any issues raised by patients. Participants are informed of self-management techniques and this may subsequently improve their quality of life. The results of this study will also impact how fibromyalgia treatment is managed.

Where is the study run from?
The trial team are based within the University of the West of England or within the Royal National Hospital for Rheumatic Diseases (Royal United Hospitals Bath NHS Trust). The trial sites are:
1. Chippenham Community Hospital
2. Charlotte Keel Medical Practice

When is the study starting and how long is it expected to run for?
January 2019 to April 2021 (updated 02/12/2020, previously: December 2020)

Who is funding the study?
Chartered Society of Physiotherapy Charitable Trust (UK)

Who is the main contact?
Dr Jen Pearson
Jen.Pearson@uwe.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

University of the West of England
University/education

Faculty of Health and Applied Sciences
Frenchay Campus
Cold Harbour Lane
Bristol
BS16 1QY
England
United Kingdom

Phone	+44 (0)117 3281670
Email	Olena.Doran@uwe.ac.uk
Website	www.uwe.ac.uk
"ROR"	https://ror.org/02nwg5t34

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

13/07/2022: Publication reference added.
10/03/2022: The following changes have been made:
1. The intention to publish date has been changed from 06/10/2021 to 01/05/2022.
2. The individual participant data (IPD) sharing statement has been added and the IPD sharing summary has been changed from "Data sharing statement to be made available at a later date" to "Stored in publicly available repository".
09/09/2021: The intention to publish date has been changed from 06/08/2021 to 06/10/2021.
13/05/2021: The intention to publish date was changed from 06/04/2021 to 06/08/2021. The total final enrolment number was added.
02/12/2020: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2020 to 06/04/2021.
2. The intention to publish date was changed from 31/01/2021 to 06/04/2021.
3. The plain English summary was updated to reflect these changes.
07/09/2020: Publication reference added.
09/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 19/12/2019 to 01/11/2019.
2. The intention to publish date has been changed from 31/01/2020 to 31/01/2021.
23/04/2019: Trial's existence confirmed by the NIHR.