Holistic Interventions for Chronic Pain

(PROs Trial)

Not yet recruiting at 4 trial locations

Overseen By Rachel Mayhew, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brooke Army Medical Center

Disqualifiers: Cancer treatment, Pregnancy, Advanced pain management, others

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

Compensation: Varies

Number of Visits: 14

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals with long-term muscle and joint pain find relief without medication. It examines two approaches: Empowered Relief, a one-time, two-hour class teaching pain management and relaxation techniques, and Move to Health, which employs health coaches to assist in habit change and pain improvement. The trial compares these methods to the usual care people receive. It suits those who have experienced chronic musculoskeletal pain for an extended period, particularly if they have had at least two medical visits for it in the past year. As an unphased trial, this study provides a unique opportunity to investigate innovative pain management strategies without medication.

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 focuses on non-drug treatments for chronic pain, so it's best to ask the trial organizers for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Empowered Relief, a two-hour class teaching pain management skills, is generally easy for people to handle. Studies indicate it helps reduce pain and improve coping skills without major side effects. Participants have reported lasting benefits for several months.

For Move to Health, a health coaching program, evidence suggests it is safe and helpful. This program encourages healthier habits and has increased physical activity and reduced pain. No major negative effects have been reported.

Both Empowered Relief and Move to Health focus on holistic care, meaning they are non-invasive and avoid medication side effects. This makes them promising options for safely managing chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for chronic pain because they offer innovative, holistic approaches that differ from traditional options like medication and physical therapy. Empowered Relief is unique because it delivers comprehensive pain management in a single, two-hour session, using techniques like pain education and relaxation exercises, which could make it a quicker option for patients seeking relief. Move to Health stands out by incorporating health coaching, fostering a collaborative relationship between patients and coaches to encourage healthy behavior changes, potentially leading to lasting improvements in pain management. These methods emphasize self-management and holistic care, providing new avenues for patients to manage chronic pain effectively.

What evidence suggests that this trial's treatments could be effective for chronic pain?

This trial will compare the effectiveness of Empowered Relief and Move to Health for managing chronic pain. Research has shown that Empowered Relief can significantly reduce stress related to pain. In one study, participants experienced a 42.25% drop in negative thoughts about pain after just one session, with results comparable to eight sessions of cognitive behavioral therapy (CBT). Empowered Relief also improves sleep, reduces pain interference, and alleviates depression and anxiety.

For Move to Health, studies have found that this method helps manage long-term pain and promotes healthier living. Health coaching, a key component of Move to Health, has successfully increased physical activity and lowered pain levels. This approach focuses on creating a supportive partnership between patients and health coaches to encourage lasting behavioral changes. ^{1 3 6 7 8}

Who Is on the Research Team?

Julie M Fritz, PhD

Principal Investigator

University of Utah

Daniel I Rhon, PhD

Principal Investigator

Brooke Army Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals in the Military Health System with chronic musculoskeletal pain, which may include conditions like rheumatic disorders or somatoform disorders. Participants should be seeking non-drug treatments.

Inclusion Criteria

TRICARE Beneficiary

I have chronic muscle or joint pain with at least 2 doctor visits in the last year.

Exclusion Criteria

Currently known to be pregnant

Suicidal Ideation determined by a higher than lower risk score on the P4 Screener

I am in rehab after surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Treatment

Participants are randomized to Usual Care, Empowered Relief, or Move to Health for initial treatment

14 weeks

Initial visit for randomization and treatment allocation

Phase II Treatment

Non-responders to Empowered Relief receive Move to Health as a secondary intervention

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks

Assessments at 14, 26, and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Empowered Relief
• Move to Health

Trial Overview

The study tests two holistic health interventions: 'Empowered Relief', a psychological strategy, and 'Move to Health', a physical activity program, against the standard care provided by primary care providers.

How Is the Trial Designed?

Group I: Empowered Relief Active Control 1 Intervention

Empowered Relief uses a single, 2-hour session to accomplish several key tasks including; pain education; experiential exercises; didactic content on pain responses, stress, and tension; techniques to affect the relaxation response; basic unhelpful thought restructuring; self-soothing actions; and completion of a per-sonalized self-management plan for empowered relief. Similar to CBT relaxation, ER participants receive a calming tool in the form of a binaural app. Unlike CBT, ER is mainly didactic, omits content such as activity planning and pacing, and is provided in a single session, eliminating ongoing therapeutic alliance and peer support.

Group II: Move to Health Active Control 1 Intervention

Move to Health (M2H) is part of an initiative in the Military Health System to transform healthcare delivery with emphasis on the power of holistic care and self-management. M2H is operationalized using a health coaching model based on collaborative part-nership between patient and a trained coach to facilitate healthy behavior change. Health coaching is an evidence-based intervention for persons with chronic pain with improvements in physical activity, pain intensity and interference.

Group III: Usual Care Active Control 1 Intervention

Usual care (UC) pain management will be provided at the discretion of the participant's primary care provider, consistent with a pragmatic clinical trial. Persons assigned to UC will be advised to follow the recommendations from their primary care provider and will be provided information about local resources at their respective Military Treatment Facility. The study team will not take additional steps to standardize or compel adherence to practice guidelines and will collect health care utilization outcomes through the the Millitary Health System Data Repository at the conclusion of the trial.

Who Is Running the Clinical Trial?

Brooke Army Medical Center

Lead Sponsor

Trials

134

Recruited

28,100+

Madigan Army Medical Center

Collaborator

Trials

52

Recruited

17,600+

Desmond Doss Health Clinic, Schofield Barracks

Collaborator

Trials

1

Recruited

530+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

59th Medical Wing

Collaborator

Trials

42

Recruited

12,700+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Bassett Army Community Hospital

Collaborator

Published Research Related to This Trial

In a pilot randomized control trial involving 83 participants with chronic pain, an 8-week yoga intervention significantly improved occupational performance and satisfaction, with performance scores increasing by 27% and satisfaction scores by 78%.

Participants in the yoga group also showed a decrease in depression symptoms, with scores dropping significantly, indicating that yoga may be an effective holistic treatment for managing chronic pain and its associated challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga improves occupational performance, depression, and daily activities for people with chronic pain. Schmid, AA., Van Puymbroeck, M., Fruhauf, CA., et al.[2019]

A review of 40 reports from 2003 to 2013 identified 138 adverse events (AEs) related to pain-related massage, highlighting that while serious complications like disc herniation and spinal cord injury can occur, the overall incidence of these events is low.

The findings suggest that although massage therapies carry some risks, particularly with spinal manipulation, they are generally considered safe when performed by qualified practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of massage therapy in pain-related conditions: a systematic review. Yin, P., Gao, N., Wu, J., et al.[2022]

A systematic review of 23 studies found that the majority of adverse events (AEs) following osteopathic manipulative treatment (OMT) were mild, accounting for 98% of reported AEs, indicating a generally safe profile for this treatment.

The study established a patient safety benchmark for post-OMT AEs at 1.0 AEs per 100 post-OMT interval-days, providing a reference point for future research and comparisons in patient safety within osteopathic manipulative medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. Unger, MD., Barr, JN., Brower, JA., et al.[2023]

A review of 10 randomized controlled trials on acupuncture for pain relief found that only 6 studies reported adverse events, and most did not adequately detail how these events were collected or assessed.

The findings indicate that acupuncture trials have not fully adhered to the updated CONSORT guidelines for reporting adverse events, highlighting the need for improved documentation to ensure patient safety and better understanding of potential risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in acupuncture clinical trials focusing on pain. Capili, B., Anastasi, JK., Geiger, JN.[2022]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10824382/

Empowered Relief, cognitive behavioral therapy, and ...

A One-session empowered relief provides clinically meaningful effects comparable to an 8-session cognitive behavioral therapy at 6 months for chronic low back ...

3.

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?

4.

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, ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2783047

Comparison of a Single-Session Pain Management Skills ...

Empowered relief was noninferior to CBT for sleep disturbance, pain bothersomeness, depression, and anxiety, but not for fatigue and self- ...

6.

empoweredrelief.stanford.edu

empoweredrelief.stanford.edu/

Welcome to Empowered Relief

Empowered Relief is a two-hour intervention that provides individuals with essential pain relief skills, delivered by certified clinicians.

7.

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.

8.

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 ...