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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Empowered Relief (ER) consists of a single-session, 2-hour group class.
BehavioralER is rooted in cognitive behavioral theory and incorporates pain education, self-regulatory skills and mindfulness principle
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
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.
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.
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.
Sponsors and contacts
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Université de Sherbrooke
Lead sponsor
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Collaborator