Pain Education Program Optimization (PEPO) Trial (PEPO)

January 5, 2024 updated by: Jean-Sébastien Roy, Laval University

Optimization of a Chronic Pain Self-management Program - a Pilot Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this pilot randomized controlled trial (RCT) is to compare the short-, mid-, and long-term effects (10 and 26 weeks following the start of the intervention) of two different modes of delivering a self-management program for chronic pain (self-management vs. enhanced self-management, offering two physiotherapist-led and one patient-partner-led sessions) on pain-related disability in a group of patients with chronic musculoskeletal (MSK) pain. Secondary objectives include comparing the effects of the two delivery modes on pain severity and on psychological constructs related to pain, namely kinesiophobia, catastrophizing, pain self-efficacy, anxiety, and depression.

The hypothesis is that the results will support both modes of delivery, but that the enhanced self-management program will lead to larger effects on pain-related disability and pain intensity.

Methodology Participants: 86 adults (aged between 18 and 75) with chronic MSK pain (>3 months) will be included. Potential participants will be recruited from waiting lists of pain-management programs and through email lists and social media.

Study design: This parallel group RCT will include three evaluation sessions over six months (baseline, 10 and 26 weeks) and, for the enhanced self-management group, three in-person meetings over 10 weeks. Questionnaires will be completed online using the REDCap web application. At baseline, participants will first complete a questionnaire on sociodemographic, symptomatology and comorbidity. Self-administered questionnaires for assessing primary and secondary outcomes will be completed by participants at all evaluation sessions. A global rating of change question will also be completed at 10 and 26 weeks. For the enhanced self-management group, the in-person meetings will be carried out at Centre interdisciplinaire de recherche en réadaptation et intégration sociale (Cirris). Ethics approval has been obtained from the sectorial rehabilitation and social integration research ethics committee of the CIUSSS-CN (project #2024-2935).

Randomisation/blinding: A randomisation list has established prior to the beginning of the study using a random number generator. An independent research assistant not involved in data collection generated the randomisation list. Randomisation is stratified to ensure balance of the treatment groups with respect to self-reported gender (3 categories : man, woman, and all other gender identities). A blocked randomisation was used to make sure that two equal groups of 43 participants will be obtained. Participants will be unaware of the intervention delivery mode received by the other group.

Outcomes: Outcomes were selected based on Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations, which attest to the good psychometric properties of the selected outcomes. See the outcomes section for details on primary and secondary outcomes measures.

Statistical analyses: Descriptive statistics will be used for all outcome measures at each measurement time to summarise results. The dataset will also be explored to check the distribution of the data. The effect sizes (Cohen's d) will be calculated between groups at each timepoint.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having musculoskeletal pain for more than 3 months.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pain self-management
Participants will complete an online pain self-management education program by themselves as it is intended.
Behavioral: Pain self-management program

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/

Other Names:
  • "Agir pour moi" (Acting for me)
Experimental: Pain self-management with support from a physiotherapist
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

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/

Other Names:
  • "Agir pour moi" (Acting for me)
Behavioral: Additional support for self-management program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-related functional limitations
Time Frame: Change from baseline at 10 weeks, change from baseline at 26 weeks

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global condition change since start of intervention, assessed by a global rating of change question
Time Frame: At 10 weeks and 26 weeks
A global rating of change question ("Overall, have you noticed any change in your condition since you entered the research project [start of intervention]?"), answered on a 15-item Likert scale ranging from -7 (Very greatly deteriorated) to 7 (Very greatly improved).
At 10 weeks and 26 weeks
Pain Severity
Time Frame: Change from baseline at 10 weeks, change from baseline at 26 weeks

The Pain Severity subscale from the short form of the Brief Pain Inventory questionnaire (BPI-SF).

Calculated as the mean of the four items on pain severity of the BPI-SF, with a score ranging from 0 (No pain) to 10 (Pain as bad as you can imagine).
Change from baseline at 10 weeks, change from baseline at 26 weeks
Kinesiophobia
Time Frame: Change from baseline at 10 weeks, change from baseline at 26 weeks
The 13-item Tampa Scale of Kinesiophobia (TSK-13). Each item is scored on a 1 to 4 scale, with a total score ranging from 13 (least kinesiophobia) to 52 (most kinesiophobia).
Change from baseline at 10 weeks, change from baseline at 26 weeks
Pain catastrophizing
Time Frame: Change from baseline at 10 weeks, change from baseline at 26 weeks
The 6-item short form of the Pain Catastrophizing Scale (PCS-6). Calculated as the sum of the 6 items, with a score ranging from 0 (lowest level of pain catastrophizing) to 24 (highest level of pain catastrophizing).
Change from baseline at 10 weeks, change from baseline at 26 weeks
Pain-related Self-Efficacy
Time Frame: Change from baseline at 10 weeks, change from baseline at 26 weeks
The 10-item Pain Self-Efficacy Questionnaire (PSEQ-10). Score ranges from 0 to 60, where high scores indicate greater levels of confidence in dealing with pain.
Change from baseline at 10 weeks, change from baseline at 26 weeks
Anxiety and Depression
Time Frame: Change from baseline at 10 weeks, change from baseline at 26 weeks
The 4-item Patient Health Questionnaire (PHQ-4). Calculated as the sum of the 4 items, with a score ranging from 0 (no signs or symptoms) to 12 (most severe signs and symptoms).
Change from baseline at 10 weeks, change from baseline at 26 weeks
Patient Acceptable Symptom State (PASS)
Time Frame: At baseline, 10 weeks, and 26 weeks
PASS simple question ("Taking into account all your activities of daily living, your level of pain, and also your functional limitations, do you consider your current condition to be satisfactory?"), answered by "Yes" or "No".
At baseline, 10 weeks, and 26 weeks
Patient satisfaction with intervention
Time Frame: At 10 weeks (end of intervention period)

4 questions to ask the participants if they are satisfied of :

  1. the intervention they received globally;
  2. the intervention mode, i.e. the way it was delivered;
  3. the content of the sessions;
  4. the tools they received to apply the advice received. The choice of answers for each question is : "Unsatisfied" or "Satisfied"
At 10 weeks (end of intervention period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Quebec Pain Research Network

Investigators

  • Principal Investigator: Jean-Sébastien Roy, PhD, Laval University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-2935

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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