Virtual Empowered Relief for Chronic Pain

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05057988
• Other study ID #: IRB-60855
• Status: Completed
• Phase: N/A
• Start date: September 8, 2021
• Est. completion date: February 2, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2, 2024
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford Pain Relief Innovations Lab	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	RTI International

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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