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Clinical Trials/NCT05057988
NCT05057988
Completed
Not Applicable

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

Stanford University1 site in 1 country73 target enrollmentSeptember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Pain
Sponsor
Stanford University
Enrollment
73
Locations
1
Primary Endpoint
Perceived Usefulness
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2021
End Date
February 2, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Beth Darnall

Professor

Stanford University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Perceived Usefulness

Time Frame: once immediately after class

How useful was the information presented in the class? (a single item, 0-10 scale, higher scores correspond to greater perceived usefulness).

Participant Satisfaction

Time Frame: once immediately after class

Please rate your overall satisfaction with the class (a Single Item, 0-10 Scale, higher scores correspond to greater satisfaction).

Likelihood of Using the Skills

Time Frame: once immediately after class

How likely are you to use the skills and information you learned? (a Single Item, 0-10 Scale, higher scores correspond to greater likelihood)

Secondary Outcomes

  • Pain Bothersomeness(At 1 month post-tx)
  • PCS Total Scores(At 1 month post-tx)
  • Pain Intensity(At 1 month post-tx)
  • PROMIS-Sleep Disturbance(At 1 month post-tx)

Study Sites (1)

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