Chronic PainPEPONCT06174246
Pain Education Program Optimization (PEPO) Trial
A study testing Pain self-management program and Additional support for self-management program in people with Chronic Pain and Musculoskeletal Pain, run by Laval University at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Pain self-management program and Additional support for self-management program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteCanada
- Study dates
- 11 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having musculoskeletal pain for more than 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jean Tittley, MSc contact
Canada1 site, 1 recruiting
- Recruiting
Cirris (Centre interdisciplinaire de recherche en réadaptation et intégration sociale)
Québec, G1M 2S8
Jean-Sébastien Roy, PhD, 418 529-9141 ext. 46005, jean-sebastien.roy@fmed.ulaval.ca
Jean Tittley, MSc, 418 529-0324, jean.tittley@cirris.ulaval.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Being tested
- Pain self-management program, Additional support for self-management program
- Keywords
- Randomized Controlled Trial, Patient Education as Topic, Self-Management, Non-Cancer Chronic Pain
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain self-management programBehavioural
Also called "Agir pour moi" (Acting for me)
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 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pain self-management | Active comparator | Participants will complete an online pain self-management education program by themselves as it is intended. Receives: 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. Receives: Behavioral: Pain self-management program; Behavioral: Additional support for self-management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from baseline at 10 weeks, change from baseline at 26 weeks
Secondary outcomes (8)
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).
Measured: Change from baseline at 10 weeks, change from baseline at 26 weeks
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).
Measured: Change from baseline at 10 weeks, change from baseline at 26 weeks
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).
Measured: Change from baseline at 10 weeks, change from baseline at 26 weeks
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.
Measured: Change from baseline at 10 weeks, change from baseline at 26 weeks
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).
Measured: Change from baseline at 10 weeks, change from baseline at 26 weeks
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".
Measured: At baseline, 10 weeks, and 26 weeks
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).
Measured: At 10 weeks and 26 weeks
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"
Measured: At 10 weeks (end of intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start11 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Self-management program, with or without support from a physiotherapist.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Quebec Pain Research Network
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174246
- Sponsor's protocol ID
- 2024-2935
- Acronym
- PEPO
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Chronic Pain Self-management Program - a Pilot Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06174246
- Acronym / sponsor ID
- PEPO / 2024-2935
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Keywords
- Randomized Controlled Trial, Patient Education as Topic, Self-Management, Non-Cancer Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Quebec Pain Research Network
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Self-management program, with or without support from a physiotherapist.
| Arm | Type | Receives |
|---|---|---|
| Pain self-management | Active comparator | Behavioral: Pain self-management programParticipants will complete an online pain self-management education program by themselves as it is intended. |
| Pain self-management with support from a physiotherapist | Experimental | Behavioral: Pain self-management program, Behavioral: Additional support for self-management programParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having musculoskeletal pain for more than 3 months.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain self-management programAlso: "Agir pour moi" (Acting for me)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/ | Behavioural | Pain self-management, Pain self-management with support from a physiotherapist |
| Additional support for self-management programThis 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. | Behavioural | Pain self-management with support from a physiotherapist |
Primary outcome
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).
8 secondary outcomes
Pain Severity
Time frame: 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
Pain catastrophizing
Time frame: 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
Anxiety and Depression
Time frame: 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
Global condition change since start of intervention, assessed by a global rating of change question
Time frame: At 10 weeks and 26 weeks
Patient satisfaction with intervention
Time frame: At 10 weeks (end of intervention period)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Website of the self-management pain education program, hosted and managed by the Quebec Pain Research Network (QPRN).Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Tittley, MSc contact
Jean-Sébastien Roy, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain self-management program and Additional support for self-management program in people with Chronic Pain and Musculoskeletal Pain, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Sébastien Roy, PhD (418-529-9141 ext. 46005, jean-sebastien.roy@fmed.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain-related functional limitations (time frame: Change from baseline at 10 weeks, change from baseline at 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.