Improved management of patients with fibromyalgia: Implementation and evaluation of an integrated care model

Evaluation of a multicomponent rehabilitation program for patients with fibromyalgia in primary health care compared to treatment as usual combined with a short patient education program: Effects on patient global impression of change, disease related symptoms, physical activity and work ability

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN96836577

Enrollment

140

Registered

2016-07-12

Start date

2016-11-01

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

Fibromyalgia/widespread musculoskeletal pain Musculoskeletal Diseases Fibromyalgia/widespread musculoskeletal pain

Interventions

Participants will be randomised one of two groups: Intervention group: Participants take part in a multicomponent rehabilitation programme in their home municipality. The programme comprises a 10-ses

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Rheumatologist confirmed diagnosis of fibromyalgia according to the American College of Rheumatology 2011 criteria 2. Aged between 20 and 50

Exclusion criteria

Exclusion criteria: 1. Comorbid inflammatory rheumatic disease 2. Serious psychiatric disorder 3. Other disease impeding physical activity 4. Not at all been working during the last two years because of disease 5. Not able to understand and speak Norwegian

Design outcomes

Primary

Measure	Time frame
Patient global impression of change (PGIC) measured by a 7-point self-reported Likert scale ranging from 1 (“I feel very much worse”) through 4 (“no change”) to 7 (“I feel very much better”) one year after inclusion. Scores of 6 and 7 are considered clinically relevant improvement. The primary outcome will be measured after completion of the VTP (4 months) and at 12 months follow-up.	—

Secondary

Measure	Time frame
All outcomes will be measured at baseline (before randomisation), at 4 months and 12 months: 1. Pain measured by Numeric Rating Scale (NRS, 0-10) 2. Fatigue measured by Numeric Rating Scale (NRS, 0-10) 3. Sleep quality measured by Numeric Rating Scale (NRS, 0-10) 4. Psychological distress measured by General Health Questionnaire-12 (GHQ-12) 5. Physical activity measured by 4 questions from the Norwegian HUNT-study 6. Work ability measured by the Work Productivity and Activity Impairment Questionnaire (WPAI) Added 04/05/2021: 7. Tendency to be mindful measured using the Five Facet Mindfulness Questionnaire (FFMQ) at baseline (before randomisation), at 4 months and 12 months 8. Motivation and barriers to physical activity measured using the Exercise Beliefs and Exercise Habits questionnaire at baseline (before randomisation), at 4 months and 12 months 9. Health-related quality of life measured using the EuroQol (EQ-5D-5L) at baseline (before randomisation), at 4 months and 12 months	—

Measure

Time frame

All outcomes will be measured at baseline (before randomisation), at 4 months and 12 months: 1. Pain measured by Numeric Rating Scale (NRS, 0-10) 2. Fatigue measured by Numeric Rating Scale (NRS, 0-10) 3. Sleep quality measured by Numeric Rating Scale (NRS, 0-10) 4. Psychological distress measured by General Health Questionnaire-12 (GHQ-12) 5. Physical activity measured by 4 questions from the Norwegian HUNT-study 6. Work ability measured by the Work Productivity and Activity Impairment Questionnaire (WPAI) Added 04/05/2021: 7. Tendency to be mindful measured using the Five Facet Mindfulness Questionnaire (FFMQ) at baseline (before randomisation), at 4 months and 12 months 8. Motivation and barriers to physical activity measured using the Exercise Beliefs and Exercise Habits questionnaire at baseline (before randomisation), at 4 months and 12 months 9. Health-related quality of life measured using the EuroQol (EQ-5D-5L) at baseline (before randomisation), at 4 months and 12 months

—

Countries

Norway

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 22, 2026