Empowered Relief for Chronic Pain

Recruiting at 1 trial location

Overseen By Beth Darnall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Cognitive impairment, Previous participation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 session

110 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial organizers or your doctor.

What data supports the effectiveness of the treatment Empowered Relief for chronic pain?

Empowering patients to manage their chronic pain, as seen in the research, can lead to better outcomes by giving them the knowledge and skills to make informed decisions about their care. ^{1 2 3 4 5}

How is the Empowered Relief treatment different from other treatments for chronic pain?

Empowered Relief is unique because it is a non-drug, telehealth-based program that focuses on personal development, peer support, and learning about pain management, offering a holistic approach to chronic pain without relying on medications. ^{6 7 8 9 10}

What is the purpose of this trial?

Empowered Relief (ER) is a 1-session pain relief skills intervention that is delivered in-person or online by certified clinicians to groups of patients with acute or chronic pain. Prior work in has shown ER efficacy for reducing chronic pain, pain-related distress, and other symptoms 6 months post-treatment. The purpose of this randomized trial is to conduct the first feasibility and early efficacy test of online Spanish ER delivered to Spanish-speaking adult patients with chronic pain. Participants will be followed for 1 month via 3 follow-up surveys (immediately after treatment, 2 weeks and 1 month post-treatment).

Research Team

Beth Darnall, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for Spanish-speaking adults over 18 years old who have chronic pain, meaning they've felt pain on most days for at least six months. Participants must understand English and be able to follow the study's procedures.

Inclusion Criteria

I have been experiencing pain for at least 3 months.

English fluency

Ability to adhere to and complete study procedures

Exclusion Criteria

I have difficulty with memory or thinking clearly.

Previous participation in the Empowered Relief class

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 1-session (two-hour) online Spanish Empowered Relief intervention delivered by a certified instructor

1 session

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment through follow-up surveys

4 weeks

3 surveys (immediately after treatment, 2 weeks, and 1 month post-treatment)

Treatment Details

Interventions

• Empowered Relief

Trial Overview The trial tests 'Empowered Relief,' a one-time online group session teaching pain relief skills by certified clinicians, against usual care. The effectiveness will be measured immediately after treatment, then two weeks and one month later through surveys.

Participant Groups

Group I: Usual Care (waitlist) Experimental Treatment 1 Intervention

Participants will continue their usual clinical care.

Group II: 1-Session pain relief skills class (online Spanish Empowered Relief) Experimental Treatment 1 Intervention

Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to a group of patients by a Spanish-fluent certified instructor using a standardized treatment manual and electronic slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.

Empowered Relief is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Empowered Relief for:

• Chronic pain
• Acute pain
• Pain-related distress

Approved in European Union as Empowered Relief for:

• Chronic pain
• Acute pain
• Pain-related distress

Approved in Canada as Empowered Relief for:

• Chronic pain
• Acute pain
• Pain-related distress

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

SCAN Health Plan

Collaborator

Trials

1

Recruited

110+

Findings from Research

Access to specialist pain services in the UK is limited, with only a small percentage of individuals with chronic pain receiving the care they need.

Empowering patients with knowledge and skills to self-manage their chronic pain can enhance their quality of life and lead to better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient empowerment and choice in chronic pain management. Barrie, J.[2019]

The Cancer Pain Education for Patients and the Public (CPEPP) project aims to enhance pain management by providing essential education to patients and the public about cancer-related pain.

The CPEPP curriculum offers resources and support to ensure effective implementation of pain education, highlighting its importance in improving overall pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer pain education for patients and the public. Ferrell, BR., Juarez, G.[2019]

Empowerment in cancer pain management is crucial, with key concepts including self-efficacy, active patient participation, and shared decision-making, as identified in a review of 34 studies.

The proposed conceptual model emphasizes the importance of both professional treatment and patient involvement, suggesting that effective pain management should integrate the roles of healthcare providers and patients for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient empowerment in cancer pain management: an integrative literature review. Te Boveldt, N., Vernooij-Dassen, M., Leppink, I., et al.[2022]

Interdisciplinary multimodal pain rehabilitation programs (IMMRP) showed moderate improvements in pain intensity, daily life interference, vitality, and health among chronic pain patients, based on a study analyzing 22 outcomes at three time points: before, after, and 12 months post-rehabilitation.

Patients with the most severe conditions before starting IMMRP experienced the greatest benefits, but the initial clinical presentation only accounted for 8% of the variation in overall improvement, indicating that predicting individual outcomes remains challenging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moderate and Stable Pain Reductions as a Result of Interdisciplinary Pain Rehabilitation-A Cohort Study from the Swedish Quality Registry for Pain Rehabilitation (SQRP). Ringqvist, Å., Dragioti, E., Björk, M., et al.[2020]

Combining patient-reported outcomes (PROs) with electronic health records (EHRs) can enhance comparative effectiveness research (CER) in chronic pain management, providing a more comprehensive understanding of treatment efficacy.

The University of Pittsburgh's patient outcomes repository exemplifies this approach, demonstrating how linked PROs and EHR data can be utilized to inform better treatment strategies for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of data collection and analysis guidelines for comparative effectiveness research in chronic pain using patient-reported outcomes and electronic health records. Dressler, AM., Gillman, AG., Wasan, AD.[2020]

The EMPOWER study is a comprehensive, multi-state, randomized controlled trial designed to help patients with chronic pain safely reduce long-term opioid use through three different approaches: cognitive behavioral therapy, self-management, and usual care.

By collecting detailed patient-reported data and using real-time feedback, the study aims to provide valuable insights into the effectiveness of these methods for opioid tapering, ultimately improving patient outcomes and satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. Darnall, BD., Mackey, SC., Lorig, K., et al.[2021]

The ePEEP program, a telehealth adaptation of the Patient Education Empowerment Programme for chronic pain, was found to be acceptable and feasible for participants, indicating its potential as a valuable resource for pain management during the COVID-19 pandemic.

Participants reported significant benefits from ePEEP, including personal development, relationship building, and enhanced learning about pain, suggesting that telehealth can effectively support chronic pain management and empower individuals in their health journeys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. Ernstzen, D., Keet, J., Louw, KA., et al.[2023]

The EMPOWER trial is a randomized controlled study involving approximately 400 chronic pain patients on long-term opioid therapy, aiming to evaluate the effectiveness of a web-based self-management program (E-Health) in reducing opioid use and pain levels.

Preliminary evidence suggests that the E-Health program can help decrease self-reported morphine equivalent dose (MED) while also alleviating pain, addressing the challenges of opioid dependency and limited access to non-drug therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. Winhusen, T., Wilson, M., Dolor, RJ., et al.[2023]

The Empower Veterans Program (EVP) significantly reduced mortality risk by 65% among Veterans with chronic pain and opioid use, indicating its potential effectiveness in improving health outcomes.

Engaged participants in the EVP showed lower depression scores post-treatment compared to non-engaged participants, suggesting that active participation in the program may enhance mental health alongside pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a non-pharmacological interdisciplinary pain rehabilitation and functional restoration program for chronic pain in veterans. Ward, R., Rauch, SAM., Axon, RN., et al.[2023]

In-depth interviews with six women participating in a group treatment for chronic musculoskeletal pain revealed that recognition from peers significantly enhanced their strength, confidence, and awareness, leading to improved coping with their pain.

The study suggests that the concept of 'recovery competence' is more beneficial than traditional notions of 'coping ability,' as it emphasizes the development of skills to manage chronic pain and improve quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encountering the continuing challenges for women with chronic pain: recovery through recognition. Werner, A., Steihaug, S., Malterud, K.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient empowerment and choice in chronic pain management. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cancer pain education for patients and the public. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Patient empowerment in cancer pain management: an integrative literature review. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Moderate and Stable Pain Reductions as a Result of Interdisciplinary Pain Rehabilitation-A Cohort Study from the Swedish Quality Registry for Pain Rehabilitation (SQRP). [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

A narrative review of data collection and analysis guidelines for comparative effectiveness research in chronic pain using patient-reported outcomes and electronic health records. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol. [2021]

7. England pubmed.ncbi.nlm.nih.gov

"So, you must understand that that group changed everything": perspectives on a telehealth group intervention for individuals with chronic pain. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Design considerations for a remote randomized multi-site clinical trial evaluating an e-health self-management program for chronic pain patients receiving opioid therapy. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a non-pharmacological interdisciplinary pain rehabilitation and functional restoration program for chronic pain in veterans. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Encountering the continuing challenges for women with chronic pain: recovery through recognition. [2017]