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 (ER-CHUS -Ortho)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Empowered Relief (ER) consists of a single-session, 2-hour group class.

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:

1. Empowered Relief (ER): A single-session, 2-hour intervention based on cognitive behavioral therapy (CBT) principles, designed to teach patients pain self-management strategies.
2. 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 Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • CIUSSSE de l'Estrie CHUS
      • Contact: Sonia Bédard; Phone Number: 13927 819-346-1110; Email: sonia.bedard2@usherbrooke.ca
      • Contact: Catherine Raynauld; Phone Number: 13831 819-346-1110; Email: catherine.raynauld@usherbrooke.ca
      • Sub-Investigator: Frédéric Balg
      • Principal Investigator: Magalie Angers
      • Sub-Investigator: Bernard Larue
      • Sub-Investigator: Margaux Courgeon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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+

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Empowered Relief (ER); 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	Behavioral: 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
No Intervention: Waitlist Control (WLC); Participants randomized to the waitlist control arm will be instructed to continue with their usual medical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Less than 7 days Post ER session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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"	3-months post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medication	Pain medication use will be assessed using a self-report medication questionnaire asking participants which medications they have used to relieve pain in the past 2 weeks. Medication categories include: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAIDs), Muscle relaxants, Opioid/narcotic analgesics, Neuropathic pain medications (e.g., gabapentin, pregabalin), Antidepressants used for pain, Cannabis and Other (specified by participant). For each category, participants indicate frequency of use: As needed (occasionally), Regularly, Used previously but stopped.	Baseline
Pain medication	Pain medication use will be assessed using a self-report medication questionnaire asking participants which medications they have used to relieve pain in the past 2 weeks. Medication categories include: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAIDs), Muscle relaxants, Opioid/narcotic analgesics, Neuropathic pain medications (e.g., gabapentin, pregabalin), Antidepressants used for pain, Cannabis and Other (specified by participant). For each category, participants indicate frequency of use: As needed (occasionally), Regularly, Used previously but stopped.	6-weeks post-surgery
Pain medication	Pain medication use will be assessed using a self-report medication questionnaire asking participants which medications they have used to relieve pain in the past 2 weeks. Medication categories include: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAIDs), Muscle relaxants, Opioid/narcotic analgesics, Neuropathic pain medications (e.g., gabapentin, pregabalin), Antidepressants used for pain, Cannabis and Other (specified by participant). For each category, participants indicate frequency of use: As needed (occasionally), Regularly, Used previously but stopped.	3-months post-surgery
Pain management method	Use of non-pharmacological pain management approaches will be assessed using a self-report questionnaire asking participants which non-medication resources they consulted or used to relieve pain during the past month. Categories include: Physiotherapy, Occupational therapy, Massage therapy, Psychology services, Self-care strategies (e.g., ice, heat, self-massage), and Other (specified by participant). Participants will indicate frequency of use for each category: 1-2 times, 3-10 times, More than 10 times.	6-weeks post-surgery
Pain management method	Use of non-pharmacological pain management approaches will be assessed using a self-report questionnaire asking participants which non-medication resources they consulted or used to relieve pain during the past month. Categories include: Physiotherapy, Occupational therapy, Massage therapy, Psychology services, Self-care strategies (e.g., ice, heat, self-massage), and Other (specified by participant). Participants will indicate frequency of use for each category: 1-2 times, 3-10 times, More than 10 times.	3-months post-surgery

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: August 25, 2025
• First Submitted That Met QC Criteria: January 29, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: chronic pain; Postoperative Pain; behavioral health; Elective Orthopedic Surgery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: CÉRCIUSSSEstrieCHUS_2025-5666

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