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NCT Number: NCT06940986

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bassett Army Community Hospital, Fairbanks, Alaska, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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).

  3. 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)

  4. 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).

  5. 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).

  6. 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).

  7. 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)."

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Mayhew, DPT

CONTACT

[email protected]

Tina Greenlee, PhD

CONTACT

[email protected]

210-808-2575

Sponsors and collaborators

Lead sponsor

Brooke Army Medical Center

Fed

Collaborators

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

Registry information

Acronym: PROs

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 23, 2025
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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