Pain Education Program Optimization (PEPO) Trial

Chronic Pain Clinical Trial

— PEPO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174246
• Other study ID #: 2024-2935
• Status: Recruiting
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Laval University
• Contact: Jean-Sébastien Roy, PhD
• Phone: 418-529-9141
• Email: jean-sebastien.roy[@]fmed.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

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/
• 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.

Locations

Country	Name	City	State
Canada	Cirris (Centre interdisciplinaire de recherche en réadaptation et intégration sociale)	Québec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Quebec Pain Research Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Severity	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
Secondary	Kinesiophobia	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
Secondary	Pain catastrophizing	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
Secondary	Pain-related Self-Efficacy	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
Secondary	Anxiety and Depression	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
Secondary	Patient Acceptable Symptom State (PASS)	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
Secondary	Global condition change since start of intervention, assessed by a global rating of change question	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
Secondary	Patient satisfaction with intervention	4 questions to ask the participants if they are satisfied of : the intervention they received globally; the intervention mode, i.e. the way it was delivered; the content of the sessions; 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)

External Links

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