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Virtual Empowered Relief for Chronic Pain

Primary Purpose

Chronic Pain, Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Empowered Relief class
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford Pain Relief Innovations LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Empowered Relief

Arm Description

Outcomes

Primary Outcome Measures

Perceived usefulness/utility
How useful was the information presented in the class?
Participant satisfaction
Please rate your overall satisfaction with the class
Likelihood of using the skills
How likely are you to use the skills and information you learned?

Secondary Outcome Measures

Pain Bothersomness
How "bothersome" your pain had been during the previous week?
PCS total scores
The Pain Catastrophizing Scale total scores
Pain Intensity
How would you rate your pain on average in the past 7 days?
Sleep disturbance
PROMIS-Sleep Disturbance short form T scores

Full Information

First Posted
September 8, 2021
Last Updated
August 12, 2023
Sponsor
Stanford University
Collaborators
RTI International
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1. Study Identification

Unique Protocol Identification Number
NCT05057988
Brief Title
Virtual Empowered Relief for Chronic Pain
Official Title
Virtual Empowered Relief for People With Chronic Pain Who Take Methadone or Buprenorphine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
RTI International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empowered Relief
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Empowered Relief class
Intervention Description
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 Measure Information:
Title
Perceived usefulness/utility
Description
How useful was the information presented in the class?
Time Frame
once immediately after class
Title
Participant satisfaction
Description
Please rate your overall satisfaction with the class
Time Frame
once immediately after class
Title
Likelihood of using the skills
Description
How likely are you to use the skills and information you learned?
Time Frame
once immediately after class
Secondary Outcome Measure Information:
Title
Pain Bothersomness
Description
How "bothersome" your pain had been during the previous week?
Time Frame
At 1 month post-tx
Title
PCS total scores
Description
The Pain Catastrophizing Scale total scores
Time Frame
At 1 month post-tx
Title
Pain Intensity
Description
How would you rate your pain on average in the past 7 days?
Time Frame
At 1 month post-tx
Title
Sleep disturbance
Description
PROMIS-Sleep Disturbance short form T scores
Time Frame
At 1 month post-tx
Other Pre-specified Outcome Measures:
Title
Pain interference
Description
PROMIS-Pain Interference short form T scores
Time Frame
At 1 month post-tx
Title
Depression
Description
PROMIS-Depression short form T scores
Time Frame
At 1 month post-tx
Title
Anxiety
Description
PROMIS-Anxiety short form T scores
Time Frame
At 1 month post-tx
Title
Physical Function
Description
PROMIS-Physical Function short form T Scores
Time Frame
At 1 month post-tx
Title
Global Impression of change
Description
The global impression of change
Time Frame
At 1 month post-tx
Title
Craving
Description
How much do you crave opiates now?
Time Frame
At 1 month post-tx

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dokyoung S You, PhD
Phone
650-724-9320
Email
dsyou@stanford.edu
Facility Information:
Facility Name
Stanford Pain Relief Innovations Lab
City
Palo Alto
State/Province
California
ZIP/Postal Code
27604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dokyoung S You, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
34398206
Citation
Darnall BD, Roy A, Chen AL, Ziadni MS, Keane RT, You DS, Slater K, Poupore-King H, Mackey I, Kao MC, Cook KF, Lorig K, Zhang D, Hong J, Tian L, Mackey SC. Comparison of a Single-Session Pain Management Skills Intervention With a Single-Session Health Education Intervention and 8 Sessions of Cognitive Behavioral Therapy in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2021 Aug 2;4(8):e2113401. doi: 10.1001/jamanetworkopen.2021.13401. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229739.
Results Reference
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PubMed Identifier
24851056
Citation
Darnall BD, Sturgeon JA, Kao MC, Hah JM, Mackey SC. From Catastrophizing to Recovery: a pilot study of a single-session treatment for pain catastrophizing. J Pain Res. 2014 Apr 25;7:219-26. doi: 10.2147/JPR.S62329. eCollection 2014.
Results Reference
background
PubMed Identifier
34022930
Citation
Ziadni MS, Anderson SR, Gonzalez-Castro L, Darnall BD. Comparative efficacy of a single-session "Empowered Relief" videoconference-delivered group intervention for chronic pain: study protocol for a randomized controlled trial. Trials. 2021 May 22;22(1):358. doi: 10.1186/s13063-021-05303-8.
Results Reference
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Virtual Empowered Relief for Chronic Pain

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