The PASSAGE Program: a structured multicomponent interdisciplinary group intervention for the self-management of chronic low back pain

• Register: ISRCTN
• Last refreshed on: 6 July 2015
• Main ID: ISRCTN15669062
• Date of registration: 08/10/2014
• Prospective Registration: No
• Primary sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke (Canada)
• Public title: The PASSAGE Program: a structured multicomponent interdisciplinary group intervention for the self-management of chronic low back pain
• Scientific title: Multicomponent interdisciplinary group intervention for the self-management of non-specific chronic low back pain: A multicenter randomized controlled trial
• Date of first enrolment: 01/01/2010
• Target sample size: 64
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15669062
• Study type: Interventional
• Study design: Multicenter open-label randomized wait-list controlled trial (Treatment)

Countries of recruitment

Canada

Contacts

• Name: Manon Choinière

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 years or older
2. Had a medical diagnosis of non-specific CLBP based on recognized criteria.
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 reported major pain syndromes other than CLBP such as arthritis or life threatening diseases such as cancer
2. Physical/psychiatric disorders that could compromise their participation in the study

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Non-specific chronic low back pain
Musculoskeletal Diseases

Intervention(s)

1. Intervention group: The PASSAGE program is a structured multicomponent interdisciplinary group intervention aimed at reducing CLBP 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.

Primary Outcome(s)

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

Secondary Outcome(s)

1. Progress during rehabilitation treatment (Quebec Back Pain Disability Scale)
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 eight sessions of the PASSAGE Program (T1), and 3 months later (T2).

Secondary ID(s)

N/A

Source(s) of Monetary Support

Community Alliances for Health Research and Knowledge Exchange in Pain of the Canadian Institutes of Health Research (CIHR) (Canada), AstraZeneca Canada Inc. (Grant # 86787) (Canada), Pfizer Canada Inc. (Canada)