AzTrials
AzTrials

Chronic PainNCT05057988

Virtual Empowered Relief for Chronic Pain

A study testing Empowered Relief class in people with Chronic Pain and Pain, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain, Pain
What is being tested?
Empowered Relief class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteUnited States
Study dates
8 Sep 2021to 2 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age at least 18 years old
  • Chronic Pain (> 3 months)
  • Taking Methadone or Buprenorphine
  • English Fluency

Who cannot join

  • Pregnant,
  • Gross Cognitive Impairment,
  • Acute Suicidality,
  • Severe Depression

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford Pain Relief Innovations Lab

    Palo Alto, California, 27604

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Chronic Pain, Pain
Being tested
Empowered Relief class
Medical subject headings
Chronic Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empowered Relief classBehavioural

    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.

Study groups in NCT05057988
Study groupRoleWhat they receive
Empowered ReliefExperimentalNot described
Receives: Behavioral: Empowered Relief class

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Usefulness

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

    Measured: once immediately after class

  2. Participant Satisfaction

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

    Measured: once immediately after class

  3. Likelihood of Using the Skills

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

    Measured: once immediately after class

Secondary outcomes (4)

  1. Pain Bothersomeness

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

    Measured: At 1 month post-tx

  2. PCS Total Scores

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

    Measured: At 1 month post-tx

  3. Pain Intensity

    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)

    Measured: At 1 month post-tx

  4. PROMIS-Sleep Disturbance

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

    Measured: At 1 month post-tx

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2021
  2. Study start8 Sep 2021
  3. Primary completion23 Oct 2023
  4. Study completion2 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single intervention
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05057988
Sponsor's protocol ID
IRB-60855
Status last verified
Mar 2025
First submitted
8 Sep 2021
Last updated
16 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34398206

  • 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.

    PubMed 24851056

  • 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.

    PubMed 34022930

  • Klein MR, Darnall BD, You DS. Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial. JMIR Res Protoc. 2024 Jun 6;13:e53784. doi: 10.2196/53784.

    PubMed 38843513

  • You D, Edwards KA, Ziadni MS, Kim S, Klein MR, Cox R, Raney E, Kuchera J, Darnall BD. Feasibility and Preliminary Efficacy of Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Single-Arm National Pilot Study. JMIR Form Res. 2026 Mar 11;10:e86070. doi: 10.2196/86070.

    PubMed 41812186

Questions about this trial

What is this clinical trial studying?

A study testing Empowered Relief class in people with Chronic Pain and Pain, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Usefulness (time frame: once immediately after class). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05057988, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Virtual Empowered Relief for Chronic Pain | AzTrials