The PASSAGE Program: a structured multicomponent interdisciplinary group intervention for the self-management of fibromyalgia.

Not Applicable

Completed

• Conditions: Fibromyalgia syndrome (FMS), chronic pain; Musculoskeletal Diseases; Fibromyalgia

• Registration Number: ISRCTN14526380
• Lead Sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. Aged 18 years or older
2. Had a medical diagnosis of FMS based on the American College of Rheumatology (ACR) classification criteria for at least 6 months
3. Reported pain of at least moderate intensity (at least 4/10) in the seven days prior to enrolment
4. Were motivated to attend all group sessions and to integrate the proposed self-management strategies
5. Agreed to not introduce new medications or treatments/therapies over the course of the PASSAGE program

Exclusion Criteria

1. Subjects who presented pain-related symptoms commonly associated with FMS (e.g., irritable bowel syndrome, migraine)
2 Those who suffered from chronic pain syndromes other than FMS (e.g., painful diabetic neuropathy)
3. Physical/psychiatric disorders that could compromise their participation in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity. Pain intensity was measured with a standardized numerical rating scale (NRS)

Secondary Outcome Measures

Name	Time	Method
1. Severity of FMS (Fibromyalgia Impact Questionnaire)<br>2. Pain interference (Brief Pain Inventory)<br>3. Impact of pain on sleep quality (Chronic Pain Sleep Inventory) <br>4. Pain coping strategies and (Coping Strategy Questionnaire) <br>5. Tendency to catastrophize (Pain Catastrophizing Scale) <br>6. Depressive symptoms (The Beck Depression Inventory) <br>7. Health-related quality of life (SF-12v2)<br>8. Patient global impression of change (PGIC) <br>9. Perceived pain relief (0 to 100% Pain Relief Scale)<br><br>Quantitative data were collected in both study groups at baseline (T0), after the intervention group completed the 8 sessions of the PASSAGE Program (T1), and 3 months later (T2). In order to document and further capture the intervention group patients? experiences, face-to-face open ended group narrative qualitative interviews were conducted 6 to 9 months after completion of the PASSAGE Program.