Pain Education Program Optimization (PEPO) Trial

NCT06174246 | Unknown

• 1 other identifier: 2024-2935
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two different modes of delivering a self-management program for chronic pain (independently vs. with additional support) on pain-related disability. Participants with chronic musculoskeletal pain will take part in a 10-week online pain self-management program. For the participants in the group with additional support, the intervention will also include two physiotherapist-led sessions and one group session with other participants. The hypothesis is that the results will support that both modes of delivery could be effective, but the self-management program with additional support will be more effective for reducing pain intensity and pain disability compared to the self-management program alone.

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

Randomized Controlled Trial; Patient Education as Topic; Self-Management; Non-Cancer Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain-related functional limitations

  The Pain Interference subscale from the short-form of the Brief Pain Inventory questionnaire (BPI-SF). Calculated as the mean of the seven interferences items of the BPI-SF, with a score ranging from 0 (does not interfere) to 10 (completely interferes).

  Change from baseline at 10 weeks, change from baseline at 26 weeks

Secondary Outcomes (8)

• Pain Severity

  Change from baseline at 10 weeks, change from baseline at 26 weeks

• Kinesiophobia

  Change from baseline at 10 weeks, change from baseline at 26 weeks

• Pain catastrophizing

  Change from baseline at 10 weeks, change from baseline at 26 weeks

• Pain-related Self-Efficacy

  Change from baseline at 10 weeks, change from baseline at 26 weeks

• Anxiety and Depression

  Change from baseline at 10 weeks, change from baseline at 26 weeks

Study Arms (2)

Pain self-management

ACTIVE COMPARATOR

Participants will complete an online pain self-management education program by themselves as it is intended.

Behavioral: Pain self-management program

Pain self-management with support from a physiotherapist

EXPERIMENTAL

Participants will complete an online pain self-management education program, and, during the treatment period, will take part in two sessions with a physiotherapist and one group session led by a peer living with chronic MSKP.

Behavioral: Pain self-management program; Behavioral: Additional support for self-management program

Interventions

Pain self-management program BEHAVIORAL

Agir pour moi (Acting for me) is a chronic pain self-management program designed to be followed independently online. The eight modules, normally spread over eight weeks and taking about 60 to 90 minutes per week to complete, focus on different strategies for managing pain on a daily basis. The structured lessons include videos, audio capsules, activities, and written information, also provided in an audio format. The program covers goal setting, stress management through relaxation, breathing and mindfulness, pacing, physical activity, thoughts and emotions, sleep, nutrition, flare-up management, and planning. The program was developed through a partnership between various chronic pain interest groups, and is hosted and managed by the Leadership Chair in Chronic Pain Education.-MEDISCA de l'Université Laval, Québec, Canada. See ClinicalTrials entry NCT05319652 https://gerermadouleur.ca/agir-pour-moi/

Also known as: "Agir pour moi" (Acting for me)

Pain self-management; Pain self-management with support from a physiotherapist

Additional support for self-management program BEHAVIORAL

This intervention is designed to give extra support to patients completing the online pain education program. It consists of two visits with a physiotherapist, and one group session led by a peer living with chronic musculoskeletal pain. Sessions with the physiotherapist will occur at the beginning of the program and at the midway point. They will be used first to present the objectives and the components of the self-management program, to reinforce its potential to improve the participant's ability to manage their pain, and then to answer the participant's questions on the program and follow up on the regular completion of the lessons. The group session will be co-facilitated by a physiotherapist and a patient-partner, and will include participants who have completed at least six weeks of the program. It will serve as a discussion forum to share helpful pain self-management strategies, lived experiences with pain and facilitators in completing the program.

Pain self-management with support from a physiotherapist

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having musculoskeletal pain for more than 3 months.

You may not qualify if:

• Unable to participate throughout the 26 weeks of the study.
• Having a diagnosis of rheumatoid, inflammatory or neurodegenerative diseases, fibromyalgia or of complex regional pain syndrome.
• Having received a corticosteroid injection in the previous twelve weeks.

Sponsors & Collaborators

• Laval University: lead
• Quebec Pain Research Network: collaborator

Study Sites (1)

Cirris (Centre interdisciplinaire de recherche en réadaptation et intégration sociale)

Québec, G1M 2S8, Canada

RECRUITING

Related Links

• Website of the self-management pain education program, hosted and managed by the Quebec Pain Research Network (QPRN).

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jean-Sébastien Roy, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Sébastien Roy, PhD

CONTACT

418-529-9141; jean-sebastien.roy@fmed.ulaval.ca

Jean Tittley, MSc

CONTACT

jean.tittley@cirris.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment is masked as all outcomes are derived from self-administered questionnaires that will be filled online without the presence of any member of the research team. Data analysis will be masked (intervention groups will be coded).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Self-management program, with or without support from a physiotherapist.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: December 11, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)