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

Browse trials for

• Chronic Pain 2,930
• Pain, Postoperative 5,093

Keywords

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

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 134 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Study arms

• Experimental
  Empowered Relief (ER)

  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.

• No intervention
  Waitlist Control (WLC)

  Participants randomized to the waitlist control arm will be instructed to continue with their usual medical care.

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

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

5. General Self-Efficacy - Short Form 4a

   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.

   Time frame: 6-weeks post-surgery

6. General Self-Efficacy - Short Form 4a

   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.

   Time frame: 3-months post-surgery

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

   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.

   Time frame: 6-weeks post-surgery

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

   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.

   Time frame: 3-months post-surgery

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

   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.

   Time frame: 6-weeks post-surgery

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

    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.

    Time frame: 3-months post-surgery

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

    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.

    Time frame: 6-weeks post-surgery

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

    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.

    Time frame: 3-months post-surgery

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

    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.

    Time frame: 6-weeks post-surgery

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

    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.

    Time frame: 3-months post-surgery

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

    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.

    Time frame: 6-weeks post-surgery

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

    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.

    Time frame: 3-months post-surgery

17. Short Assessment of Patient Satisfaction (SAPS)

    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"

    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

5. 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: 3-months post-surgery

Individual participant data

Plan to share: No