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Virtual Empowered Relief for Chronic Pain

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ClinicalTrials.gov Identifier: NCT05057988
Recruitment Status : Recruiting
First Posted : September 27, 2021
Last Update Posted : August 3, 2022
RTI International
Information provided by (Responsible Party):
Beth Darnall, 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Pain Behavioral: Empowered Relief class Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine
Actual Study Start Date : September 8, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Empowered Relief Behavioral: Empowered Relief class
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 Outcome Measures :
  1. Perceived usefulness/utility [ Time Frame: once immediately after class ]
    How useful was the information presented in the class?

  2. Participant satisfaction [ Time Frame: once immediately after class ]
    Please rate your overall satisfaction with the class

  3. Likelihood of using the skills [ Time Frame: once immediately after class ]
    How likely are you to use the skills and information you learned?

Secondary Outcome Measures :
  1. Pain Bothersomness [ Time Frame: At 1 month post-tx ]
    How "bothersome" your pain had been during the previous week?

  2. PCS total scores [ Time Frame: At 1 month post-tx ]
    The Pain Catastrophizing Scale total scores

  3. Pain Intensity [ Time Frame: At 1 month post-tx ]
    How would you rate your pain on average in the past 7 days?

  4. Sleep disturbance [ Time Frame: At 1 month post-tx ]
    PROMIS-Sleep Disturbance short form T scores

Other Outcome Measures:
  1. Pain interference [ Time Frame: At 1 month post-tx ]
    PROMIS-Pain Interference short form T scores

  2. Depression [ Time Frame: At 1 month post-tx ]
    PROMIS-Depression short form T scores

  3. Anxiety [ Time Frame: At 1 month post-tx ]
    PROMIS-Anxiety short form T scores

  4. Physical Function [ Time Frame: At 1 month post-tx ]
    PROMIS-Physical Function short form T Scores

  5. Global Impression of change [ Time Frame: At 1 month post-tx ]
    The global impression of change

  6. Craving [ Time Frame: At 1 month post-tx ]
    How much do you crave opiates now?

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05057988

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Contact: Dokyoung S You, PhD 650-724-9320 dsyou@stanford.edu

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United States, California
Stanford Pain Relief Innovations Lab Recruiting
Palo Alto, California, United States, 27604
Contact: Dokyoung S You, PhD         
Sponsors and Collaborators
Stanford University
RTI International
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Responsible Party: Beth Darnall, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT05057988    
Other Study ID Numbers: IRB-60855
First Posted: September 27, 2021    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Neurologic Manifestations