Virtual Empowered Relief for Chronic Pain
- Conditions
- Chronic PainPain
- Interventions
- Behavioral: Empowered Relief class
- Registration Number
- NCT05057988
- Lead Sponsor
- Stanford University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age at least 18 years old
- Chronic Pain (> 3 months)
- Taking Methadone or Buprenorphine
- English Fluency
- Pregnant,
- Gross Cognitive Impairment,
- Acute Suicidality,
- Severe Depression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Empowered Relief Empowered Relief class -
- Primary Outcome Measures
Name Time Method Perceived usefulness/utility once immediately after class How useful was the information presented in the class?
Likelihood of using the skills once immediately after class How likely are you to use the skills and information you learned?
Participant satisfaction once immediately after class Please rate your overall satisfaction with the class
- Secondary Outcome Measures
Name Time Method Pain Bothersomness At 1 month post-tx How "bothersome" your pain had been during the previous week?
Sleep disturbance At 1 month post-tx PROMIS-Sleep Disturbance short form T scores
Pain Intensity At 1 month post-tx How would you rate your pain on average in the past 7 days?
PCS total scores At 1 month post-tx The Pain Catastrophizing Scale total scores
Trial Locations
- Locations (1)
Stanford Pain Relief Innovations Lab
🇺🇸Palo Alto, California, United States