Fibromyalgia community self-management feasibility trial

A feasibility randomised controlled trial (RCT) of a fibromyalgia self-management programme (FSMP) in a community setting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10824225

Enrollment

Registered

2019-04-29

Start date

2019-03-06

Completion date

Unknown

Last updated

2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Musculoskeletal Diseases Fibromyalgia

Interventions

Patient participants will be randomised to either usual care or referred to one of two local community sites where the 6-week FSMP intervention will be delivered. A range of outcome data including fib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 and over with a confirmed diagnosis of FM according to ACR (2016) diagnostic criteria 2. Willingness to take part in a group based intervention 3. Ability to travel to attend the group sessions

Exclusion criteria

Exclusion criteria: 1. Those under 18 years of age 2. Diagnosed with rheumatoid arthritis 3. Generalised Anxiety Disorder Questionnaire (GAD-7) score >15 4. Has previously attended the RUHB FSMP or pain management programme 5. Needs a carer to attend the FSMP 6. Needs an interpreter to communicate in English

Design outcomes

Primary

Measure	Time frame
1. The ability to recruit adults with FM to the trial from primary care by 24 months 2. Attrition rate recorded as the number of participants that remain until the end of follow up at 6 months 3. Feasibility of collecting outcome data from patients recruited to the trial 4. Identify the primary outcome for a future full trial 5. Recruitment rate to inform a full trial 6. Sample size calculations to inform a full trial	—

Measure

Time frame

1. The ability to recruit adults with FM to the trial from primary care by 24 months 2. Attrition rate recorded as the number of participants that remain until the end of follow up at 6 months 3. Feasibility of collecting outcome data from patients recruited to the trial 4. Identify the primary outcome for a future full trial 5. Recruitment rate to inform a full trial 6. Sample size calculations to inform a full trial

—

Secondary

Measure	Time frame
Measured at baseline, 6 weeks and 6 months: 1. Self-efficacy to self-manage FMS symptoms assessed using Arthritis Self-Efficacy 8-item scale 2. Disabling fatigue in hospital and community settings assessed using Chalder fatigue scale 3. Health economic data collected using Client Service Receipt Inventory 4. Quality of life assessed using EQ-5D-5L Health Questionnaire 5. Impact of fibromyalgia symptoms assessed using revised fibromyalgia impact questionnaire (FIQR) 6. Sleep quality assessed using Jenkins Sleep Questionnaire 7. Quality of life assessed using SF-36 health survey questionnaire	—

Measure

Time frame

Measured at baseline, 6 weeks and 6 months: 1. Self-efficacy to self-manage FMS symptoms assessed using Arthritis Self-Efficacy 8-item scale 2. Disabling fatigue in hospital and community settings assessed using Chalder fatigue scale 3. Health economic data collected using Client Service Receipt Inventory 4. Quality of life assessed using EQ-5D-5L Health Questionnaire 5. Impact of fibromyalgia symptoms assessed using revised fibromyalgia impact questionnaire (FIQR) 6. Sleep quality assessed using Jenkins Sleep Questionnaire 7. Quality of life assessed using SF-36 health survey questionnaire

—

Countries

England, United Kingdom

Contacts

Public ContactJessica Coggins

jessica.coggins@uwe.ac.uk+44 (0)117 3288427

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026