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

NCT07392099 | Recruiting

• 1 other identifier: CÉRCIUSSSEstrieCHUS_2025-5666
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain

Keywords

Postoperative Pain; Elective Orthopedic Surgery; chronic pain; behavioral health

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (17)

• Pain Catastrophizing Scale

  6-weeks post-surgery

• Pain Catastrophizing Scale

  3-months post-surgery

• Pain Self-Efficacy Questionnaire (PSEQ)

  6-weeks post-surgery

• Pain Self-Efficacy Questionnaire (PSEQ)

  3-months post-surgery

• General Self-Efficacy - Short Form 4a

  6-weeks post-surgery

Other Outcomes (5)

• Pain medication

  Baseline

• Pain medication

  6-weeks post-surgery

• Pain medication

  3-months post-surgery

Study Arms (2)

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

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.

Interventions

Empowered Relief (ER) consists of a single-session, 2-hour group class. BEHAVIORAL

ER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle

Empowered Relief (ER)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

CIUSSSE de l'Estrie CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and research staff will know arm assignment. Co-investigators, project statisticians, and the protocol director at each study site will remain blinded until final assessment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Clinical trial randomizing to one of two groups: (1) standard care; and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief)

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: February 6, 2026
• Study Start: May 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)