The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System

NCT06940986 | Not Yet Recruiting DMC

• 1 other identifier: Pending
• Study Type: interventional
• Target: 608
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Chronic Pain; Musculoskeletal Pain; Musculoskeletal Pain Disorder

Keywords

Empowered Relief; Move to Health; Holistic Pain Care; stepped care; chronic musculoskeletal pain; self-management; pain management; military; holistic health

Outcome Measures

Primary Outcomes (1)

• 3-PEG Scale

  The three items include 1 pain intensity item (Pain intensity during the past week) and 2 pain interference items (Pain interference with Enjoyment of life, and pain interference with General activity). The total score is the average of the three items (range, 0-10; higher scores indicate worse pain impact)

  From enrollment to the end of treatment at 14 weeks

Secondary Outcomes (9)

• PROMIS Physical Function

  From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)

• PROMIS Sleep Disturbance

  From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)

• 3-PEG Scale

  From enrollment to the end of the surveillance period (26 and 52 weeks)

• PROMIS Depression

  From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)

• PROMIS Fatigue

  From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)

Study Arms (3)

Empowered Relief

ACTIVE COMPARATOR

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.

Behavioral: Empowered Relief

Move to Health

ACTIVE COMPARATOR

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.

Behavioral: Move to Health

Usual Care

ACTIVE COMPARATOR

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.

Other: Usual Care as determined by primary care provider

Interventions

Empowered Relief BEHAVIORAL

ER is provided in a single, 2-hour session delivered remotely by trained instructors. ER has two main components: didactics and skills acquisition as outlined below. The ER class is administered virtually. The class includes the didactic and skill acquisition content. At the end of the class participants receive tangible items including the self-crafted, personalized catastrophizing cessation plan, a guided relaxation response audio file, and an electronic copy of the didactic class content.

Empowered Relief

Move to Health BEHAVIORAL

The M2H intervention is delivered virtually by trained health coaches using a 6-step process. The administration of M2H begins with an initial session with follow-up sessions scheduled every 1-2 weeks for up to 8 weeks or until the participant is ready to transition to self-management.

Move to Health

Usual Care as determined by primary care provider OTHER

Patients will receive care as determined by their primary care provider, with no input or control by the research team.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• TRICARE Beneficiary
• Meets the case definition of chronic MSK pain requiring 2 or more medical encounters within the past year and at least 90 days apart for the same MSK condition indicated by medical encounter data or MSK pain ICD-10 codes in the electronic medical record

You may not qualify if:

• Actively receiving cancer treatment
• Currently known to be pregnant
• Receiving advanced chronic pain management, including multi-disciplinary or behavioral pain management or mental health or substance use programs (beyond the initial step of the VA/DoD stepped care model for pain management)
• Suicidal Ideation determined by a higher than lower risk score on the P4 Screener
• Currently undergoing post-surgical rehabilitation

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• 59th Medical Wing: collaborator
• Desmond Doss Health Clinic, Schofield Barracks: collaborator
• University of Utah: collaborator
• Madigan Army Medical Center: collaborator
• Bassett Army Community Hospital: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (5)

Bassett Army Community Hospital

Fairbanks, Alaska, 99703, United States

Location

Desmond Doss Health Clinic

Schofield Barracks, Hawaii, 96786, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98391, United States

Location

Related Publications (5)

• Abiero B, Gliner M, Beamer S, Sackett A, Marshall-Aiyelawo K, Ellison J, McDavid T, de Geus J. Military Medical Readiness and Patient Experience with Access to Care. Med J (Ft Sam Houst Tex). 2022 Jan-Mar;(Per 22-01/02/03):3-10.

  PMID: 34940962 BACKGROUND

• Adams RS, Thomas CP, Ritter GA, Lee S, Saadoun M, Williams TV, Larson MJ. Predictors of Postdeployment Prescription Opioid Receipt and Long-term Prescription Opioid Utilization Among Army Active Duty Soldiers. Mil Med. 2019 Jan 1;184(1-2):e101-e109. doi: 10.1093/milmed/usy162.

  PMID: 30007291 BACKGROUND

• Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/

  PMID: 22553896 BACKGROUND

• Department of Veterans Affairs. Veterans' Health Administration. Pain Management, VHA Directive 2009-053. October 28, 2009. Published 2009. Accessed August 25, 2023.

  BACKGROUND

• Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.

  PMID: 24978399 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Collagen Diseases; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Julie M Fritz, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Daniel I Rhon, PhD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina Greenlee, PhD

CONTACT

210-808-2575; tina.a.greenlee.ctr@health.mil

Rachel Mayhew, DPT

CONTACT

rachel.J.mayhew.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be stored in a repository as required by the sponsor/funder (NCCIH).
• Access Criteria: The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution. Access to data is sometimes restricted and users are expected to adhere to norms for responsible use. Restricted data files are not available for direct download from the website. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.

Locations

US (5)