The PROmoting Pain Self-Management (PROs) Trial: Holistic Pain Care in the Military Health System
Part of paid clinical trials in Fairbanks, Alaska.
- Sponsor
- Brooke Army Medical Center
- Study ID
- NCT06940986
- Status
- Recruiting
Conditions
- Chronic Pain
- Musculoskeletal Pain
- Musculoskeletal Pain Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Empowered Relief — BEHAVIORALER 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 — BEHAVIORALThe 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 — OTHERPatients will receive care as determined by their primary care provider, with no input or control by the research team.
Study Details
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.
Key Dates
- Start date
- Dec 19, 2025
- Status verified
- May 2026
- Primary completion
- Jul 1, 2027
- Completion
- Jul 1, 2028
Study Design
- Enrollment
- 608 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Empowered ReliefEmpowered 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.
- Active Comparator: Move to HealthMove 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.
- Active Comparator: Usual CareUsual 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.
Primary Outcome Measure
3-PEG Scale [ Time Frame: From enrollment to the end of treatment at 14 weeks ]
Central Contacts
- Tina Greenlee, PhD210-808-2575
- Rachel Mayhew, DPT
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Bassett Army Community Hospital | Fairbanks | Alaska | 99703 | Karyn Zaage Karyn Zaage (PRINCIPAL_INVESTIGATOR) |
| Desmond Doss Health Clinic | Schofield Barracks | Hawaii | 96786 | Roy Camacho, DPT (PRINCIPAL_INVESTIGATOR) |
| Brooke Army Medical Center | San Antonio | Texas | 78219 | Benjamin Hando (PRINCIPAL_INVESTIGATOR) |
| Wilford Hall Ambulatory Surgical Center | San Antonio | Texas | 78236 | Tina Greenlee, PhD Josh VanWyndgaarden (PRINCIPAL_INVESTIGATOR) |
| Madigan Army Medical Center | Tacoma | Washington | 98391 | Rachel J Mayhew, DPT Nicholas Molby (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Fairbanks, AK
Related Studies
- Patient Retrospective Outcomes (PRO)Recruiting · Boston Scientific Corporation · Lake Havasu City, Arizona
- Long-Term Real-World Outcomes Study on Patients Implanted With a NeurostimulatorRecruiting · Abbott Medical Devices · Phoenix, Arizona
- AIMS Medical Outcomes StudyRecruiting · Advanced Integrative Medical Science Institute · Seattle, Washington
- A Novel Medical System for Quantitative Diagnosis and Personalized Precision Botulinum Neurotoxin Injection in Chronic Pelvic Pain ManagementEARLY_PHASE1 · Not Yet Recruiting · HillMed Inc. · Houston, Texas