Virtual Empowered Relief for Chronic Pain

Study Overview
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Brief Summary
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The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

Detailed Description
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Some patients with chronic pain are on long-term opioid therapy. Methadone and buprenorphine are often used in long-term opioid therapy for chronic pain. Additionally, chronic pain is highly prevalent in people receiving methadone or buprenorphine for opioid use disorder (MOUD). It is observed that up to 68% of people with MOUD have chronic pain condition. Therefore, a large number of people taking methadone or buprenorphine will suffer from chronic pain, but they frequently face limited availability of clinicians offering non-pharmacological pain management programs. Thus, a brief internet-based pain relief skills program may be one option that can overcome such treatment barrier. A recent randomized control trial on patients with chronic low back pain has demonstrated that a single-session, 2-hour, pain management class (Empowered Relief; ER) was effective to improve pain and pain-related distress. The ER class consists of pain neuroscience education and self-regulatory skills. While the ER is a promising and scalable option, it is not yet tested in patients with chronic pain who take methadone or buprenorphine. The current proposed, single-arm, uncontrolled pilot project will determine a) a feasibility in this patient population, b) patients' perceptions and satisfaction of the ER class and c) preliminary efficacy to inform the design of a future, larger, controlled trial.

Official Title
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Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine

Conditions
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Chronic Pain, Pain

Intervention / Treatment
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* Behavioral: Empowered Relief class


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years old Chronic Pain (> 3 months) Taking Methadone or Buprenorphine English Fluency Exclusion Criteria: Pregnant, Gross Cognitive Impairment, Acute Suicidality, Severe Depression

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empowered Relief<br> | Behavioral: Empowered Relief class<br>* The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived usefulness/utility | How useful was the information presented in the class? | once immediately after class | 
| Participant satisfaction | Please rate your overall satisfaction with the class | once immediately after class | 
| Likelihood of using the skills | How likely are you to use the skills and information you learned? | once immediately after class | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Bothersomness | How bothersome your pain had been during the previous week? | At 1 month post-tx | 
| PCS total scores | The Pain Catastrophizing Scale total scores | At 1 month post-tx | 
| Pain Intensity | How would you rate your pain on average in the past 7 days? | At 1 month post-tx | 
| Sleep disturbance | PROMIS-Sleep Disturbance short form T scores | At 1 month post-tx |