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Chronic PainPROsNCT06940986

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

A study testing Empowered Relief and Move to Health in people with Chronic Pain and Musculoskeletal Pain, run by Brooke Army Medical Center at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Empowered Relief and Move to Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
608 participants
Where
5 sitesUnited States
Study dates
19 Dec 2025to 1 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Mayhew, DPT contact

rachel.J.mayhew.ctr@health.mil

5 sites in 1 country

United States5 sites, 5 recruiting
  • Bassett Army Community Hospital

    Fairbanks, Alaska, 99703

    Karyn Zaage, karyn.m.zaage.mil@health.mil

    Karyn Zaage

    Not yet recruiting
  • Brooke Army Medical Center

    San Antonio, Texas, 78219

    Tina Greenlee, PhD, 210-808-2575, tina.a.greenlee.ctr@health.mil

    Benjamin Hando

    Recruiting
  • Wilford Hall Ambulatory Surgical Center

    San Antonio, Texas, 78236

    Tina Greenlee, PhD, tina.a.greenlee.ctr@health.mil

    Josh VanWyndgaarden

    Not yet recruiting
  • Desmond Doss Health Clinic

    Schofield Barracks, Hawaii, 96786

    Aliona Megedyuk, BS, 808-433-5963, aliona.megedyuk.ctr@health.mil

    Roy Camacho, DPT

    Recruiting
  • Madigan Army Medical Center

    Tacoma, Washington, 98391

    Rachel J Mayhew, DPT, rachel.j.mayhew.ctr@health.mil

    Nicholas Molby

    Not yet recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Empowered Relief, Move to Health, Usual Care as determined by primary care provider
Keywords
Empowered Relief, Move to Health, Holistic Pain Care, stepped care, chronic musculoskeletal pain, self-management, pain management, military, holistic health
Medical subject headings
Chronic Pain, Musculoskeletal Pain, Collagen Diseases, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Empowered ReliefBehavioural

    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 HealthBehavioural

    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 providerOther

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

Study groups in NCT06940986
Study groupRoleWhat they receive
Empowered ReliefActive comparatorEmpowered 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.
Receives: Behavioral: Empowered Relief
Move to HealthActive comparatorMove 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.
Receives: Behavioral: Move to Health
Usual CareActive comparatorUsual 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.
Receives: Other: Usual Care as determined by primary care provider

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: From enrollment to the end of treatment at 14 weeks

Secondary outcomes (9)
  1. PROMIS Physical Function

    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

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

  2. PROMIS Sleep Disturbance

    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).

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

  3. 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)

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

  4. PROMIS Depression

    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).

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

  5. PROMIS Fatigue

    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).

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

  6. PROMIS Prescription Medication Misuse

    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).

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

  7. Sleep Duration

    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)."

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

  8. Pain Catastrophizing Scale (PCS)

    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.

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

  9. Pain Self-Efficacy Scale (PSEQ)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start19 Dec 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
608 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06940986
Sponsor's protocol ID
Pending
Acronym
PROs
Status last verified
May 2026
First submitted
16 Apr 2025
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified demographic data (e.g., sex, age), and participant-reported outcomes data.

Publications

  • 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.

    PubMed 34940962
  • 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.

    PubMed 30007291
  • 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/

    PubMed 22553896
  • Department of Veterans Affairs. Veterans' Health Administration. Pain Management, VHA Directive 2009-053. October 28, 2009. Published 2009. Accessed August 25, 2023.

  • 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.

    PubMed 24978399
  • Fritz JM, Rhon DI, Fino N, Greene TH, Greenlee TA, Teyhen DS, Cook D, Darnall BD. PROmoting Pain Self-Management for Chronic Musculoskeletal Pain in the Military Health System, comparing health coaching to Empowered Relief: the PROs trial protocol. Pain Med. 2026 Oct 5:pnag133. doi: 10.1093/pm/pnag133. Online ahead of print.

    PubMed 42834451

Questions about this trial

What is this clinical trial studying?

A study testing Empowered Relief and Move to Health in people with Chronic Pain and Musculoskeletal Pain, run by Brooke Army Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tina Greenlee, PhD (210-808-2575, tina.a.greenlee.ctr@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-PEG Scale (time frame: From enrollment to the end of treatment at 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06940986, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.

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