The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System
NCT ID: NCT06940986
Last Updated: 2025-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
608 participants
INTERVENTIONAL
2025-08-01
2028-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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59th Medical Wing
FED
Desmond Doss Health Clinic, Schofield Barracks
UNKNOWN
University of Utah
OTHER
Madigan Army Medical Center
FED
Bassett Army Community Hospital
UNKNOWN
National Center for Complementary and Integrative Health (NCCIH)
NIH
Brooke Army Medical Center
FED
Responsible Party
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Dan Rhon
Primary Investigator
Principal Investigators
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Julie M Fritz, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Daniel I Rhon, PhD
Role: PRINCIPAL_INVESTIGATOR
Brooke Army Medical Center
Locations
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Bassett Army Community Hospital
Fairbanks, Alaska, United States
Desmond Doss Health Clinic
Schofield Barracks, Hawaii, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Wilford Hall Ambulatory Surgical Center
San Antonio, Texas, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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/
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.
Other Identifiers
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Pending
Identifier Type: -
Identifier Source: org_study_id
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