Chronic Pain
Conditions
Keywords
Postoperative Pain, Elective Orthopedic Surgery, chronic pain, behavioral health
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.
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.
Interventions
BEHAVIORALEmpowered 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
Sponsors
Université de Sherbrooke
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Clinical trial randomizing to one of two groups: (1) standard care; and (2) single-session pain relief skills intervention for chronic pain (Empowered Relief)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity and Interference | 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. |
| Treatment Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing Scale | 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. |
| Pain Self-Efficacy Questionnaire (PSEQ) | 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. |
| General Self-Efficacy - Short Form 4a | 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. |
| PROMIS Short Form v1.0 - Depression - 8a | 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. |
| PROMIS Short Form v1.0 - Anxiety - 8a | 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. |
| PROMIS Short Form v1.0 - Sleep Disturbance 4a | 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. |
| PROMIS Short Form v2.0 - Social Isolation 4a | 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. |
| PROMIS Short Form v1.0 - Fatigue 4a | 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. |
| Short Assessment of Patient Satisfaction (SAPS) | 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" |
Countries
Canada
Outcome results
None listed