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Completed

NCT Number: NCT05057988

Virtual Empowered Relief for Chronic Pain

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Pain Relief Innovations Lab

Palo Alto, California, 27604, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empowered Relief class

Behavioral

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.

Primary outcomes

  1. 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).

  2. 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).

  3. 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

  1. Pain Bothersomeness

    Time frame: At 1 month post-tx

    How "bothersome" your pain had been during the previous week? (a Single Item, 0-10 Scale, higher scores greater bothersomeness)

  2. PCS Total Scores

    Time frame: At 1 month post-tx

    The 13-item Pain Catastrophizing Scale total score ranges from 0 to 52, higher scores correspond to greater pain catastrophizing.

  3. Pain Intensity

    Time frame: At 1 month post-tx

    How would you rate your pain on average in the past 7 days? (a single item, 0-10 scale, higher scores correspond to greater pain intensity)

  4. PROMIS-Sleep Disturbance

    Time frame: At 1 month post-tx

    PROMIS-Sleep Disturbance short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

Other outcomes

  1. PROMIS-Pain Interference

    Time frame: At 1 month post-tx

    PROMIS-Pain Interference short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

  2. PROMIS-Depression

    Time frame: At 1 month post-tx

    PROMIS-Depression short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

  3. PROMIS-Anxiety

    Time frame: At 1 month post-tx

    PROMIS-Anxiety short form T scores Mean = 50, SD = 10 Higher scores indicate worse symptoms 70T or higher considers severe symptoms

  4. PROMIS-Physical Function

    Time frame: At 1 month post-tx

    PROMIS-Physical Function short form T Scores Mean = 50, SD = 10 Higher scores indicate better function 30T or higher considers severe impairment

  5. Global Impression of Change

    Time frame: At 1 month post-tx

    The global impression of change (a single item, 1-7 scale, higher scores correspond to greater improvement)

  6. Craving

    Time frame: At 1 month post-tx

    How much do you crave opiates now? (single item, 0-10 scale, higher scores correspond to greater craving)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 27, 2021
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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