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

May 21, 2026 updated by: Dan Rhon, Brooke Army Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Chronic pain is a ubiquitous problem and growing concern for the Military Health System (MHS). Chronic musculoskeletal (MSK) pain conditions are the most common chronic pain conditions in the MHS. Numerous recommendations have been made to improve care for chronic MSK pain in the MHS. First, the Office of the Army Surgeon General is promoting the transition of the MHS to a holistic health system that seeks to maintain, restore, and improve health through team-based care supporting self-management and recognizing the complex, biopsychosocial nature of chronic pain. Second, a stepped care approach to pain management is advocated to make less intense but effective, first-line care broadly available and to base subsequent care on response to first-line options. While the MHS has articulated its vision for holistic pain care delivered within a stepped care framework, there is a need for research addressing key questions of which interventions are most effective and how to operationalize the stepped care model. In addition, pragmatic, sustainable strategies to implement holistic pain care in the MHS are needed. Electronic health records (EHR) are increasingly used to implement evidence-based interventions, but have not been widely tested in the MHS. The MHS has deployed a new system-wide EHR with standards-based capabilities for decision-support, making EHR-based implementation a timely option with high potential for future scalability.

Design: Pragmatic, individually-randomized, type I hybrid effectiveness-implementation trial Methods: The investigators will use the EMR to help facilitate recruitment. The investigators plan to recruit a total of 608 persons with chronic MSK pain receiving care in the MHS. Participants providing consent will be randomized in 1 : 2.3 : 2.3 ratio to Usual Care (UC), Empowered Relief (ER), or Move to Health (M2H) for phase I treatment. All participants will be re-evaluated after 14 weeks. Participants initially assigned to the ER, determined to be non-responders to treatment, will receive M2H as a Phase II intervention to evaluate a stepped care process. All participants will also complete assessments at 26 and 52 weeks after randomization. The primary outcome will be a self-reported measure of pain impact. Secondary outcomes will include additional effectiveness measures. The research team will also evaluate implementation outcomes grounded in a Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Summary: The goal of the promoting pain self-management (PROs) study is to improve pain care in the MHS by identifying effective, whole-person, non-pharmacologic interventions for persons with chronic MSK pain. The investigators plan to evaluate two promising, evidence-based interventions, ER and M2H, and also compare these to UC.

Study Type

Interventional

Enrollment (Estimated)

608

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alaska
      • Fairbanks, Alaska, United States, 99703
        • Not yet recruiting
        • Bassett Army Community Hospital
        • Contact:
        • Principal Investigator:
          • Karyn Zaage
    • Hawaii
      • Schofield Barracks, Hawaii, United States, 96786
        • Recruiting
        • Desmond Doss Health Clinic
        • Contact:
        • Principal Investigator:
          • Roy Camacho, DPT
    • Texas
      • San Antonio, Texas, United States, 78219
        • Recruiting
        • Brooke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Benjamin Hando
      • San Antonio, Texas, United States, 78236
        • Not yet recruiting
        • Wilford Hall Ambulatory Surgical Center
        • Principal Investigator:
          • Josh VanWyndgaarden
        • Contact:
    • Washington
      • Tacoma, Washington, United States, 98391
        • Not yet recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • Nicholas Molby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Empowered Relief
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
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.
Active Comparator: Move to Health
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
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.
Active Comparator: Usual Care

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-PEG Scale
Time Frame: From enrollment to the end of treatment at 14 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Physical Function
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PROMIS short form 6b for physical function uses fixed items from the PROMIS physical function item bank to provide a T-score with population mean = 50 (sd=10).96
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
PROMIS Sleep Disturbance
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PROMIS short form 6a for sleep disturbance uses fixed items from the PROMIS sleep disturbance item bank to provide a T-score with population mean = 50 (sd=10).
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
3-PEG Scale
Time Frame: From enrollment to the end of the surveillance period (26 and 52 weeks)
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 the surveillance period (26 and 52 weeks)
PROMIS Depression
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PROMIS short form 6a for depression uses fixed items from the PROMIS depression item bank to provide a T-score with population mean = 50 (sd=10).
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
PROMIS Fatigue
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PROMIS short form 6a for fatigue uses fixed items from the PROMIS fatigue item bank to provide a T-score with population mean = 50 (sd=10).
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
PROMIS Prescription Medication Misuse
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PROMIS short form 7a assesses the abuse of prescription pain medication over a 3-month period. The short form uses fixed items from the PROMIS item bank to provide a T-score with population mean = 50 (sd=10).
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
Sleep Duration
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
Sleep duration is assessed through a single item question that comes from the Pittsburgh Sleep Quality Index (PSQI): "During the past month, how many hours and minutes of actual sleep did you get at night? (This may be different than the number of hours and minutes you spent in bed)."
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
Pain Catastrophizing Scale (PCS)
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PCS is a 13-item scale assessing the extent to which people catastro-phize in response to pain. Each item is scored from 0-4 providing an overall score from 0-52.
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
Pain Self-Efficacy Scale (PSEQ)
Time Frame: From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)
The PSEQ is a 4-item scale assessing a person's confidence to achieve goals and perform activities even with pain. Each item is scored from 0-6 for an overall score ranging from 0-60.
From enrollment to end of surveillance period at 52 weeks (including 14 and 26 week assessments)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

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

Investigators

  • Principal Investigator: Julie M Fritz, PhD, University of Utah
  • Principal Investigator: Daniel I Rhon, PhD, Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pending (Other Grant/Funding Number: American Acedemy of Optometry Foundation (AAOF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified demographic data (e.g., sex, age), and participant-reported outcomes data.

IPD Sharing Time Frame

Data will be stored in a repository as required by the sponsor/funder (NCCIH).

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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