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

ConditionChronic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversité de Sherbrooke

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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+

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Empowered Relief (ER)Experimental treatment 1 intervention
Group B: Waitlist Control (WLC)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6-weeks post-surgery
2

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.

Time frame
3-months post-surgery
3

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.

Time frame
Less than 7 days Post ER session

Secondary outcomes

1

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.

Time frame
6-weeks post-surgery
2

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.

Time frame
3-months post-surgery
3

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.

Time frame
6-weeks post-surgery
4

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.

Time frame
3-months post-surgery

Other outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
6-weeks post-surgery
3

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.

Time frame
3-months post-surgery
4

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.

Time frame
6-weeks post-surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Université de Sherbrooke

Lead sponsor

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

Collaborator