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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a single, two-hour pain management class called Empowered Relief can assist transgender or gender-diverse individuals in managing chronic pain before gender-affirming surgery. Participants will either attend this class or continue with their usual care to determine if the class reduces pain-related distress. Ideal candidates have chronic pain lasting more than three months, a pain intensity of 4 or higher on a scale of 0-10, and are affiliated with the OHSU Transgender Health Program. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance chronic pain management for the transgender community.

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 prior data suggests that this intervention is safe for transgender or gender-diverse patients with chronic pain?

Research has shown that Empowered Relief, a method for managing pain, is generally safe and easy to handle. Studies have found that participants in Empowered Relief classes experienced significantly less distress related to their pain. For instance, one study noted a substantial reduction in how much participants focused on and worried about their pain after the class.

While these studies primarily examine its effectiveness, the few reported side effects suggest it is safe for participants. Empowered Relief, a non-invasive educational method, typically has fewer side effects than medical treatments. This makes it a promising option for managing chronic pain without the risks associated with medication or surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Empowered Relief for chronic pain because it offers a new approach to pain management that could significantly benefit patients undergoing gender-affirming surgery. Unlike standard care options, which typically involve medication or physical therapy, Empowered Relief is a pain management class designed to equip patients with cognitive and emotional tools to handle pain more effectively. This method emphasizes self-management and resilience, potentially reducing the need for pharmacological interventions and their associated side effects. By empowering patients with these skills, the hope is to improve recovery outcomes and enhance overall quality of life.

What evidence suggests that Empowered Relief might be an effective treatment for chronic pain?

Research has shown that Empowered Relief, a 2-hour single-session class, can effectively reduce chronic pain symptoms. One study found that participants experienced a 42.25% decrease in pain catastrophizing—a mindset that worsens pain—after three months. Another study demonstrated that this method can improve both pain levels and overall quality of life for individuals with chronic pain. The treatment has proven as effective as other pain management programs in delivering these benefits. In this trial, participants will either attend the Empowered Relief class or receive standard care without the class. These findings suggest that Empowered Relief could be a promising option for managing chronic pain. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8463950/

Efficacy of a Single-Session “Empowered Relief” Zoom- ... At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS −8.72, 42.25% reduction; WLC: PCS − ...

2. pcori.org pcori.org/research-results/2021/comparing-effectiveness-two-online-programs-treating-chronic-pain

Comparing the Effectiveness of Two Online Programs for ... The project compares the effectiveness of two different online programs for treating chronic pain. Who will this research inform?

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40068160

Zoom-Delivered Empowered Relief for Chronic Pain - PubMed Empowered Relief (ER), a 2-hour, single-session pain relief skills class, can improve pain and quality of life among patients with chronic pain ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2783047

Comparison of a Single-Session Pain Management Skills ... Our results suggest that empowered relief can achieve similar results across key outcomes at 3 months. We underscore that empowered relief ...

5. empoweredrelief.stanford.edu empoweredrelief.stanford.edu/healthcare-executives

Adopt Empowered Relief at your organization Proven efficacy. Published data from randomized controlled trials demonstrate the efficacy of Empowered Relief for improving pain intensity, pain interference, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05980104

Single-Session "Empowered Relief" Class for Marfan ... The study primary endpoint is change in pain intensity or pain interference from baseline to 1 month follow-up (short-term efficacy). Online delivery of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12457081/

Changes in Pain Catastrophizing and Related Outcomes ... Pain catastrophizing scores reduced by an average of 28 points, with 90% achieving clinically significant change. Participation in Empowered ...

8. formative.jmir.org formative.jmir.org/2025/1/e68292

Zoom-Delivered Empowered Relief for Chronic Pain This study examined the impact of Zoom-delivered ER among people with chronic pain on long-term opioid therapy.