Condition category
Musculoskeletal Diseases
Date applied
04/07/2014
Date assigned
23/07/2014
Last edited
18/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Fibromyalgia syndrome (FMS) is a chronic condition that causes pain all over the body. Other symptoms include an increased sensitivity to pain, extreme tiredness, muscle stiffness, headaches, depression, difficulties sleeping and problems with memory and concentration. The aim of this study is to assess the performance of a new treatment (intervention) called the PASSAGE programme, which has been developed as a series of group therapy sessions to both alleviate symptoms and help patients to self-manage their symptoms.

Who can participate?
Patients who are 18 years or over, with a medical diagnosis of FMS and motivated to fully participate in the PASSAGE programme.

What does the study involve?
Participants are randomly allocated to one of two groups. The intervention group attend 8 group sessions (with 8 people in each group). Each session covers practical and emotional techniques for coping with FMS (psycho-education), cognitive behavioral therapy-related techniques and exercise activities. A follow up group session then takes place six months after the completion of the programme. The waitlist group continue with their usual treatment until the first group completes the PASSAGE programme, after which they also take part. A series of questionnaires completed by both groups are used to assess how well the intervention performs.

What are the possible benefits and risks of participating?
Possible benefits include better self-management of FMS and alleviation of symptoms. There is little risk in taking part in the study, the only inconvenience being giving up time and resources to participate in the research (e.g. traveling, completing questionnaires).

Where is the study run from?
The University of Sherbrooke (Canada)

When is the study starting and how long is it expected to run for?
September 2009 to March 2011

Who is funding the study?
1. Community Alliances for Health Research and Knowledge Exchange in Pain of the Canadian Institutes of Health Research (CIHR) (Canada)
2. AstraZeneca Canada Inc. (Canada)
3. Pfizer Canada Inc. (Canada)

Who is the main contact?
Dr Manon Choinière
manon.choiniere@umontreal.ca

Trial website

Contact information

Type

Scientific

Primary contact

Dr Manon Choinière

ORCID ID

Contact details

Centre de recherche du Centre hospitalier de l’Université de Montréal
Tour Saint-Antoine
850
rue Saint-Denis
Bureau S03-428
Montréal
H2X 0A9
Canada
+1 (0) 514 890 8000, ext. 14082
manon.choiniere@umontreal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Multicomponent interdisciplinary group intervention for self-management of fibromyalgia: a mixed-methods randomized controlled trial

Acronym

PASSAGE

Study hypothesis

The aim of the present study was thus to evaluate, quantitatively and qualitatively, the efficacy of the PASSAGE Program - a multicomponent interdisciplinary group intervention for the self-management of fibromyalgia syndrome (FMS) for improving the clinical condition of patients suffering from this type of disorder.

Ethics approval

Ethics Committees of the University of Sherbrooke (Université de Sherbrooke), 15/05/2009, ref. 09-034
University of Québec in Abitibi-Témiscamingue (Université de Québec en Abitibi-Témiscamingue) 26/05/2009

Study design

Mixed-methods multicenter open-label randomized wait-list controlled trial with both a quantitative and a qualitative aspect

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Fibromyalgia syndrome (FMS), chronic pain

Intervention

1. Intervention group : The PASSAGE program is a structured multicomponent interdisciplinary group intervention aimed at reducing FMS symptoms and maintaining optimal function through the use of self-management strategies and patient education. The intervention consists of 8 group sessions with 8 participants lasting 2.5h each. Each session involved 3 major components
1.a. Psycho-educational tools
1.b. Cognitive behavioral therapy-related techniques
1.c. Patient-tailored exercise activities. A follow-up group session is schedule 6 months after the end of the intervention
2. Waitlist group : Participants randomized to the waitlist group were instructed to continue their treatment as usual until they could take part in the PASSAGE Program - i.e., 3 months after the intervention group had completed the program.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Severity of FMS (Fibromyalgia Impact Questionnaire)
2. Pain interference (Brief Pain Inventory)
3. Impact of pain on sleep quality (Chronic Pain Sleep Inventory)
4. Pain coping strategies and (Coping Strategy Questionnaire)
5. Tendency to catastrophize (Pain Catastrophizing Scale)
6. Depressive symptoms (The Beck Depression Inventory)
7. Health-related quality of life (SF-12v2)
8. Patient global impression of change (PGIC)
9. Perceived pain relief (0 to 100% Pain Relief Scale)

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.

Overall trial start date

01/09/2009

Overall trial end date

01/03/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64 (32 per study site)

Participant 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

Recruitment start date

01/09/2009

Recruitment end date

01/03/2011

Locations

Countries of recruitment

Canada

Trial participating centre

Centre de recherche du Centre hospitalier de l'Université de Montréal
Montréal
H2X 0A9
Canada

Sponsor information

Organisation

Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Canada)

Sponsor details

c/o Dr Patricia Bourgault
Centre de recherche du Centre hospitalier universitaire de Sherbrooke (CRCHUS)
3001
12e Avenue Nord
Sherbrooke
J1H 5N4
Canada
+1 (0) 819 346 1110, ext. 12885
patricia.bourgault@usherbrooke.ca

Sponsor type

Hospital/treatment centre

Website

http://cr.chus.qc.ca/en/axes/sante-population/chercheurs/patricia-bourgault-ph-d/

Funders

Funder type

Other

Funder name

Community Alliances for Health Research and Knowledge Exchange in Pain of the Canadian Institutes of Health Research (CIHR) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

AstraZeneca Canada Inc. (Grant # 86787) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Pfizer Canada Inc. (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25978402

Publication citations

Additional files

Editorial Notes