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NCT Number: NCT07392099

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIUSSSE de l'Estrie CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location status: Recruiting

Location contact

Bernard Larue

SUB_INVESTIGATOR

Catherine Raynauld

CONTACT

[email protected]

819-346-1110 ext. 13831

Frédéric Balg

SUB_INVESTIGATOR

Magalie Angers

PRINCIPAL_INVESTIGATOR

Margaux Courgeon

SUB_INVESTIGATOR

Sonia Bédard

CONTACT

[email protected]

819-346-1110 ext. 13927

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Pain Catastrophizing Scale

    Time frame: 6-weeks post-surgery

    Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

  2. Pain Catastrophizing Scale

    Time frame: 3-months post-surgery

    Pain Catastrophizing Scale is a 13-item measure with a total score ranging from 0-52 with higher scores indicative of more catastrophizing.

  3. Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: 6-weeks post-surgery

    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.

  4. Pain Self-Efficacy Questionnaire (PSEQ)

    Time frame: 3-months post-surgery

    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.

  5. General Self-Efficacy - Short Form 4a

    Time frame: 6-weeks post-surgery

    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. General Self-Efficacy - Short Form 4a

    Time frame: 3-months post-surgery

    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.

  7. PROMIS Short Form v1.0 - Depression - 8a

    Time frame: 6-weeks post-surgery

    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.

  8. PROMIS Short Form v1.0 - Depression - 8a

    Time frame: 3-months post-surgery

    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.

  9. PROMIS Short Form v1.0 - Anxiety - 8a

    Time frame: 6-weeks post-surgery

    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.

  10. PROMIS Short Form v1.0 - Anxiety - 8a

    Time frame: 3-months post-surgery

    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.

  11. PROMIS Short Form v1.0 - Sleep Disturbance 4a

    Time frame: 6-weeks post-surgery

    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.

  12. PROMIS Short Form v1.0 - Sleep Disturbance 4a

    Time frame: 3-months post-surgery

    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.

  13. PROMIS Short Form v2.0 - Social Isolation 4a

    Time frame: 6-weeks post-surgery

    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.

  14. PROMIS Short Form v2.0 - Social Isolation 4a

    Time frame: 3-months post-surgery

    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.

  15. PROMIS Short Form v1.0 - Fatigue 4a

    Time frame: 6-weeks post-surgery

    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.

  16. PROMIS Short Form v1.0 - Fatigue 4a

    Time frame: 3-months post-surgery

    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.

  17. Short Assessment of Patient Satisfaction (SAPS)

    Time frame: 3-months post-surgery

    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"

Other outcomes

  1. Pain medication

    Time frame: Baseline

    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.

  2. Pain medication

    Time frame: 6-weeks post-surgery

    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. Pain medication

    Time frame: 3-months post-surgery

    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.

  4. Pain management method

    Time frame: 6-weeks post-surgery

    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.

  5. Pain management method

    Time frame: 3-months post-surgery

    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.

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

Registry information

Acronym: ER-CHUS -Ortho

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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