Clinical trial NCT06174246: Pain Education Program Optimization (PEPO) Trial
Official title: Optimization of a Chronic Pain Self-management Program - a Pilot Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: Randomized Controlled Trial
Patient Education as Topic
Self-Management
Non-Cancer Chronic Pain
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Quebec Pain Research Network
First posted: 2023-12-18
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Self-management program, with or without support from a physiotherapist.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain-related functional limitations
timeFrame: Change from baseline at 10 weeks, change from baseline at 26 weeks
Secondary outcomes:
measure: Pain Severity
timeFrame: Change from baseline at 10 weeks, change from baseline at 26 weeks
measure: Kinesiophobia
timeFrame: Change from baseline at 10 weeks, change from baseline at 26 weeks
measure: Pain catastrophizing
timeFrame: Change from baseline at 10 weeks, change from baseline at 26 weeks
measure: Pain-related Self-Efficacy
timeFrame: Change from baseline at 10 weeks, change from baseline at 26 weeks
measure: Anxiety and Depression
timeFrame: Change from baseline at 10 weeks, change from baseline at 26 weeks
measure: Patient Acceptable Symptom State (PASS)
timeFrame: At baseline, 10 weeks, and 26 weeks
measure: Global condition change since start of intervention, assessed by a global rating of change question
timeFrame: At 10 weeks and 26 weeks
measure: Patient satisfaction with intervention
timeFrame: At 10 weeks (end of intervention period)
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Cirris (Centre interdisciplinaire de recherche en réadaptation et intégration sociale)
Study officials:
affiliation: Laval University
name: Jean-Sébastien Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References: