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

Not Applicable

Completed

• Conditions: Fibromyalgia/widespread musculoskeletal pain; Musculoskeletal Diseases

• Registration Number: ISRCTN96836577
• Lead Sponsor: ational Advisory Unit on Rehabilitation in Rheumatology

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29866731 2021results in https://pubmed.ncbi.nlm.nih.gov/34187823/ (added 01/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-12
• Study Completion: 2020-05-31
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 170

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.