Empowered Relief for Chronic Pain

Overseen By Sarah L. Feller, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Severe depression, Suicidality, others

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: 1

Duration: 1 day

78 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

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

Empowering patients to manage their chronic pain can lead to better outcomes, as seen in studies where patient empowerment improved pain management in cancer patients. Additionally, interdisciplinary pain rehabilitation programs have shown moderate improvements in pain and health, suggesting that similar empowerment-based approaches could be beneficial. ^{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, interdisciplinary group intervention that focuses on personal development, peer support, and learning about pain management, often delivered through telehealth, making it accessible and supportive for patients with chronic pain. ^{6 7 8 9 10}

What is the purpose of this trial?

The primary objective of this study is to examine a single-session, 2-hour group intervention provided to a population of transgender or gender-diverse patients with chronic pain prior to gender-affirming surgery, to determine if participants who receive the intervention have less pain-related distress compared to participants randomly assigned to the control group.

Eligibility Criteria

This trial is for transgender or gender-diverse individuals with chronic pain lasting more than 3 months and a pain intensity of at least 4 on a scale of 0-10. Participants must be fluent in English, affiliated with the OHSU Transgender Health Program, and have had their initial consultation for gender-affirming surgery.

Inclusion Criteria

I am fluent in English.

I am part of the OHSU Transgender Health Program and had my first surgery consultation.

I have been in pain for more than 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A single-session, 2-hour group intervention for chronic pain management prior to gender-affirming surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain-related distress and pain severity

7 months

Treatment Details

Interventions

• Empowered Relief

Trial Overview The study tests if a single-session group intervention called Empowered Relief can reduce pain-related distress before gender-affirming surgery compared to standard care. Participants are randomly assigned to either the intervention or control group.

Participant Groups

Group I: Pain Management Class Experimental Treatment 1 Intervention

Pain Management Class Prior to Gender Affirming Surgery

Group II: SOC - No Class Active Control 1 Intervention

SOC for Gender Affirming Surgery

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?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

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 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 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]

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 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]

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

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

7. 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]

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

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

9. 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]

10. 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]