Abstract
Abstract
Background
Chronic musculoskeletal pain is a major problem for military beneficiaries, with incident rates increasing more than 3-fold from 2009 to 2018. Guidelines recommend nonpharmacologic, holistic approaches within a stepped care framework. Two promising strategies, Empowered Relief (ER), a lower-intensity single-session pain self-management intervention, and Move-to-Health (M2H), a higher-intensity holistic health-coaching program, offer scalable options. However, comparative effectiveness data and optimal sequencing of these two interventions within stepped care remain unknown.
Objectives
(1) Compare the effectiveness of ER and M2H as first-line care; (2) compare each intervention to usual care (UC); (3) evaluate a stepped-care strategy of ER followed by M2H for non-responders; and (4) examine implementation outcomes using the RE-AIM framework.
Design
The PROs trial is a pragmatic, Type I hybrid effectiveness-implementation trial enrolling 608 adult TRICARE beneficiaries with chronic musculoskeletal pain from four military hospitals. Participants are randomized 2.3:2.3:1 to ER, M2H, or UC. Non-responders to Phase I ER receive M2H in Phase II. The primary outcome is pain interference on the PEG-3 at 14 weeks. Secondary outcomes include PROMIS health domains, pain catastrophizing, self-efficacy, global improvement, healthcare utilization, and opioid use. Implementation outcomes follow the RE-AIM framework.
Discussion
The PROs trial will generate critical evidence on strategies for delivering holistic pain care in the Military Health System, evaluating both the comparative effectiveness of two nonpharmacological interventions and the value of a stepped-care adaptive treatment approach. Findings will inform future pain management policies in military, veteran, and civilian health systems.
Trial Registration
ClinicalTrials.gov NCT06940986