Chronic PainER-CHUS -OrthoNCT07392099
Comparison of the Efficacy of an Empowered Relief Single-Session Versus Standard Care for Reducing Postoperative Pain Following Elective Orthopedic Surgery: A Randomized Controlled Trial
A study testing Empowered Relief (ER) consists of a single-session, 2-hour group class. in people with Chronic Pain, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the efficacy and acceptability of the French-Canadian version of ER compared to standard care in reducing postoperative pain and improving recovery outcomes at 6-week and 3-month follow-ups after elective orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Empowered Relief (ER) consists of a single-session, 2-hour group class.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteCanada
- Study dates
- 5 May 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain >4/10 for >3 months related to the surgical indication
- French fluency
- Ability to adhere to and complete study protocol
- Males and females, 18+
Who cannot join
- Participated in another project that may cause bias in the study results
- Pain related to cancer
- Cognitive impairment, non-French speaking, or factors that would preclude comprehension of material or full participation in ER
- Previous participation in ER
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CIUSSSE de l'Estrie CHUS
Sherbrooke, Quebec, J1H 5N4
Sonia Bédard, 819-346-1110 ext. 13927, sonia.bedard2@usherbrooke.ca
Catherine Raynauld, 819-346-1110 ext. 13831, catherine.raynauld@usherbrooke.ca
About this study
The purpose of this study is to evaluate the efficacy and acceptability of the French-Canadian version of ER compared to standard care in reducing postoperative pain and improving recovery outcomes at 6-week and 3-month follow-ups after elective orthopedic surgery.
Read the detailed description
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness and acceptability of two postoperative pain management approaches following elective orthopedic surgery:
- Empowered Relief (ER): A single-session, 2-hour intervention based on cognitive behavioral therapy (CBT) principles, designed to teach patients pain self-management strategies.
- Standard Care: Usual postoperative care without additional psychological intervention.
The investigators aim to determine which approach is more effective and acceptable for patients in managing postoperative pain. Ultimately, this research aims to provide a low-cost, low-risk, widely accessible, and feasible intervention.
- Conditions
- Chronic Pain
- Being tested
- Empowered Relief (ER) consists of a single-session, 2-hour group class.
- Keywords
- Postoperative Pain, Elective Orthopedic Surgery, chronic pain, behavioral health
- Medical subject headings
- Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered Relief (ER) consists of a single-session, 2-hour group class.Behavioural
ER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle
| Study group | Role | What they receive |
|---|---|---|
| Empowered Relief (ER) | Experimental | Behavioral: Empowered Relief A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.The ER session will be done between 4 to 8 weeks before the surgery. All treatment sessions will be conducted in person, in a meeting room of the CIUSSS de l'Estrie-CHUS Receives: Behavioral: Empowered Relief (ER) consists of a single-session, 2-hour group class. |
| Waitlist Control (WLC) | No intervention | Participants randomized to the waitlist control arm will be instructed to continue with their usual medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity and Interference
The Brief Pain Inventory-short form measures both the intensity of pain and the interference of pain in various aspects of the patient's life. Patients rate their pain at its "worst," "least," "average," and "now" (current pain) over the past 24 hours. Ratings are provided on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." Patients also assess how pain has interfered with seven aspects of their daily life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Measured: 6-weeks post-surgery
Pain Intensity and Interference
The Brief Pain Inventory-short form measures both the intensity of pain and the interference of pain in various aspects of the patient's life. Patients rate their pain at its "worst," "least," "average," and "now" (current pain) over the past 24 hours. Ratings are provided on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." Patients also assess how pain has interfered with seven aspects of their daily life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Measured: 3-months post-surgery
Treatment Acceptability
Acceptability of the ER session will be assessed with the Acceptability Home-based questionnaire, a 8-item measure with a total score ranging from 0-48 with higher scores indicative of more acceptability.
Measured: Less than 7 days Post ER session
Secondary outcomes (17)
Pain Catastrophizing Scale
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Measured: 6-weeks post-surgery
Pain Catastrophizing Scale
Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.
Measured: 3-months post-surgery
Pain Self-Efficacy Questionnaire (PSEQ)
The 10 item Pain Self-Efficacy Questionnaire (PSEQ) assesses self-efficacy using à 0 = "Not confident at all" to 6= "Completely confident" scale. Higher scores suggest a greater self-efficacy.
Measured: 6-weeks post-surgery
Pain Self-Efficacy Questionnaire (PSEQ)
The 10 item Pain Self-Efficacy Questionnaire (PSEQ) assesses self-efficacy using à 0 = "Not confident at all" to 6= "Completely confident" scale. Higher scores suggest a greater self-efficacy.
Measured: 3-months post-surgery
General Self-Efficacy - Short Form 4a
Compare treatment groups for self-efficacy using the PROMIS 4-item PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Self-Efficacy - Lower scores indicate lower levels of Self-Efficacy.
Measured: 6-weeks post-surgery
General Self-Efficacy - Short Form 4a
Compare treatment groups for self-efficacy using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Self-Efficacy - Lower scores indicate lower levels of Self-Efficacy.
Measured: 3-months post-surgery
PROMIS Short Form v1.0 - Depression - 8a
Compare treatment groups for depression using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Depression - Lower scores indicate lower levels of Depression.
Measured: 6-weeks post-surgery
PROMIS Short Form v1.0 - Depression - 8a
Compare treatment groups for depression using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Depression - Lower scores indicate lower levels of Depression.
Measured: 3-months post-surgery
PROMIS Short Form v1.0 - Anxiety - 8a
Compare treatment groups for anxiety using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Anxiety- Lower scores indicate lower levels of Anxiety.
Measured: 6-weeks post-surgery
PROMIS Short Form v1.0 - Anxiety - 8a
Compare treatment groups for anxiety using the PROMIS 8-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Anxiety- Lower scores indicate lower levels of Anxiety.
Measured: 3-months post-surgery
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Compare treatment groups for sleep disturbance using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Sleep disturbance - Lower scores indicate lower levels of Sleep disturbance.
Measured: 6-weeks post-surgery
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Compare treatment groups for sleep disturbance using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Sleep disturbance - Lower scores indicate lower levels of Sleep disturbance.
Measured: 3-months post-surgery
PROMIS Short Form v2.0 - Social Isolation 4a
Compare treatment groups for social isolation using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Social isolation - Lower scores indicate lower levels of Social isolation.
Measured: 6-weeks post-surgery
PROMIS Short Form v2.0 - Social Isolation 4a
Compare treatment groups for social isolation using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Social isolation - Lower scores indicate lower levels of Social isolation.
Measured: 3-months post-surgery
PROMIS Short Form v1.0 - Fatigue 4a
Compare treatment groups for fatigue using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Fatigue - Lower scores indicate lower levels of Fatigue.
Measured: 6-weeks post-surgery
PROMIS Short Form v1.0 - Fatigue 4a
Compare treatment groups for fatigue using the PROMIS 4-item. PROMIS instruments are normed on the US population and are reported using t-scores with a mean of 50 and a standard deviation of 10.
Higher scores indicate higher levels of Fatigue - Lower scores indicate lower levels of Fatigue.
Measured: 3-months post-surgery
Short Assessment of Patient Satisfaction (SAPS)
The Short Assessment of Patient Satisfaction (SAPS) assesses patients' satisfaction regarding their health care with 7 items using a 4 likert scale from "very satisfied" to "very unsatisfied"
Measured: 3-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start5 May 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (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.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial randomizing to one of two groups: (1) standard care; and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
- Responsible party
- Principal investigator, Junie Carrière, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392099
- Sponsor's protocol ID
- CÉRCIUSSSEstrieCHUS_2025-5666
- Acronym
- ER-CHUS -Ortho
- Status last verified
- Jan 2026
- First submitted
- 25 Aug 2025
- Last updated
- 6 Feb 2026
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of an Empowered Relief Single-Session Versus Standard Care for Reducing Postoperative Pain Following Elective Orthopedic Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07392099
- Acronym / sponsor ID
- ER-CHUS -Ortho / CÉRCIUSSSEstrieCHUS_2025-5666
- Conditions
- Chronic Pain
- Keywords
- Postoperative Pain, Elective Orthopedic Surgery, chronic pain, behavioral health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
- Study start
- 5 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Feb 2026 (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 purpose of this study is to evaluate the efficacy and acceptability of the French-Canadian version of ER compared to standard care in reducing postoperative pain and improving recovery outcomes at 6-week and 3-month follow-ups after elective orthopedic surgery.
Detailed description
The purpose of this study is to conduct a pragmatic clinical trial comparing the effectiveness and acceptability of two postoperative pain management approaches following elective orthopedic surgery:
- Empowered Relief (ER): A single-session, 2-hour intervention based on cognitive behavioral therapy (CBT) principles, designed to teach patients pain self-management strategies.
- Standard Care: Usual postoperative care without additional psychological intervention.
The investigators aim to determine which approach is more effective and acceptable for patients in managing postoperative pain. Ultimately, this research aims to provide a low-cost, low-risk, widely accessible, and feasible intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Clinical trial randomizing to one of two groups: (1) standard care; and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief)
| Arm | Type | Receives |
|---|---|---|
| Empowered Relief (ER) | Experimental | Behavioral: Empowered Relief (ER) consists of a single-session, 2-hour group class.Behavioral: Empowered Relief A certified instructor delivers 1 session of pain relief skills intervention (Empowered Relief) to groups of patients who were randomized to this treatment arm.The ER session will be done between 4 to 8 weeks before the surgery. All treatment sessions will be conducted in person, in a meeting room of the CIUSSS de l'Estrie-CHUS |
| Waitlist Control (WLC) | No intervention | –Participants randomized to the waitlist control arm will be instructed to continue with their usual medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pain >4/10 for >3 months related to the surgical indication
- French fluency
- Ability to adhere to and complete study protocol
- Males and females, 18+
Key exclusion criteria (4 listed)
- Participated in another project that may cause bias in the study results
- Pain related to cancer
- Cognitive impairment, non-French speaking, or factors that would preclude comprehension of material or full participation in ER
- Previous participation in ER
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 |
|---|---|---|
| Empowered Relief (ER) consists of a single-session, 2-hour group class.ER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle | Behavioural | Empowered Relief (ER) |
Primary outcome
Pain Intensity and Interference
Time frame: 6-weeks post-surgery
The Brief Pain Inventory-short form measures both the intensity of pain and the interference of pain in various aspects of the patient's life. Patients rate their pain at its "worst," "least," "average," and "now" (current pain) over the past 24 hours. Ratings are provided on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." Patients also assess how pain has interfered with seven aspects of their daily life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Pain Intensity and Interference
Time frame: 3-months post-surgery
The Brief Pain Inventory-short form measures both the intensity of pain and the interference of pain in various aspects of the patient's life. Patients rate their pain at its "worst," "least," "average," and "now" (current pain) over the past 24 hours. Ratings are provided on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine." Patients also assess how pain has interfered with seven aspects of their daily life: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Treatment Acceptability
Time frame: Less than 7 days Post ER session
Acceptability of the ER session will be assessed with the Acceptability Home-based questionnaire, a 8-item measure with a total score ranging from 0-48 with higher scores indicative of more acceptability.
17 secondary outcomes
Pain Catastrophizing Scale
Time frame: 6-weeks post-surgery
Pain Catastrophizing Scale
Time frame: 3-months post-surgery
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 6-weeks post-surgery
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: 3-months post-surgery
General Self-Efficacy - Short Form 4a
Time frame: 6-weeks post-surgery
General Self-Efficacy - Short Form 4a
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Depression - 8a
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Depression - 8a
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Anxiety - 8a
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Anxiety - 8a
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Sleep Disturbance 4a
Time frame: 3-months post-surgery
PROMIS Short Form v2.0 - Social Isolation 4a
Time frame: 6-weeks post-surgery
PROMIS Short Form v2.0 - Social Isolation 4a
Time frame: 3-months post-surgery
PROMIS Short Form v1.0 - Fatigue 4a
Time frame: 6-weeks post-surgery
PROMIS Short Form v1.0 - Fatigue 4a
Time frame: 3-months post-surgery
Short Assessment of Patient Satisfaction (SAPS)
Time frame: 3-months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief (ER) consists of a single-session, 2-hour group class. in people with Chronic Pain, run by Université de Sherbrooke 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 6 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity and Interference (time frame: 6-weeks post-surgery). The study lists 3 primary outcomes in all. 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 6 Feb 2026.