Holistic Interventions for Chronic Pain

(PROs Trial)

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

608 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic musculoskeletal pain. The investigators will evaluate two promising, evidence-based holistic health interventions and compare them to usual care.

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 the treatment generally safe for humans?

The treatment, which may include techniques like massage and acupuncture, is generally considered safe, but there are some risks. Massage therapy can sometimes lead to issues like soft tissue trauma or spinal problems, though these are rare. Acupuncture trials have improved in reporting adverse events, but specific safety data for the holistic interventions mentioned is not detailed in the available research. ^{1 2 3 4 5}

How is the treatment Empowered Relief, Move to Health different from other treatments for chronic pain?

Empowered Relief, Move to Health is unique because it combines various non-drug therapies like relaxation, meditation, and cognitive behavioral therapy (a type of talk therapy) to not only reduce pain but also improve overall function and quality of life. This holistic approach addresses both the physical and psychological aspects of chronic pain, unlike treatments that focus solely on pain reduction. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Empowered Relief, Move to Health for chronic pain?

Research shows that comprehensive pain programs, which include non-drug therapies like mind/body training and therapeutic movement, can significantly improve quality of life and reduce symptoms like depression and anxiety in chronic pain patients. ^{11 12 13 14 15}

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

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 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]

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]

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]

Citations

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Evidence-Based Nonpharmacologic Strategies for Comprehensive Pain Care: The Consortium Pain Task Force White Paper. [2022]

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Turning Pain into Gain: Evaluation of a Multidisciplinary Chronic Pain Management Program in Primary Care. [2020]

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

Comprehensive Pain Program outcomes evaluation: a preliminary study in Hawai'i. [2019]

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Patients' perceptions of a chronic pain rehabilitation program: changing the conversation. [2022]

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Adverse events of massage therapy in pain-related conditions: a systematic review. [2022]

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Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016. [2020]

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Adverse event reporting in acupuncture clinical trials focusing on pain. [2022]

9. Scotland pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Defining the landscape of patient harm after osteopathic manipulative treatment: synthesis of an adverse event model. [2023]

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[Efectividad de una intervención multimodal para la mejora de la atención al dolor crónico.] [2023]

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How to assess a new patient for a multidisciplinary chronic pain rehabilitation program: a review article. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Yoga improves occupational performance, depression, and daily activities for people with chronic pain. [2019]

14. Germany pubmed.ncbi.nlm.nih.gov

[The "healthy pain patient"]. [2021]

15. England pubmed.ncbi.nlm.nih.gov

Patient perspectives from the multi-disciplinary chronic pain clinic: a qualitative study. [2022]