Functional and Occupational Rehabilitation of Troops

Not yet recruiting

• Conditions: Chronic Musculoskeletal Pain

• Registration Number: NCT06898866
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

The proposed implementation science project will evaluate the factors that support or hinder the successful implementation of the FORT Functional Restoration Program at six Military Treatment Facilities (MTF) across the Military Health System. It will also evaluate the associated effectiveness outcomes related to chronic musculoskeletal pain management in active-duty military personnel.

Detailed Description

This project will be an effectiveness-implementation hybrid type 2 study design using a stepped-wedge randomized clinical trial research design. The study will simultaneously evaluate clinical and implementation outcomes related to the establishment of functional restoration programs. The study investigators have collaborated with the Defense Health Agency (DHA) Pain Management Clinical Support Services to identify chronic pain management programs at six MTFs interested in systematically improving and assessing the outcomes of their program. The MTFs will be randomized in pairs to initiate the Implementation Facilitation strategy to improve the implementation of their program over three 6-month intervals, after an initial 6-month baseline. This hybrid design will allow for the evaluation of both implementation and clinical effectiveness research aims and support rapid translation of research outcomes. Each site will participate in a minimum 6-month baseline period prior to the intervention period to serve as its own treatment as usual.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-07
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

"patient referred to functional restoration program by provider"

Exclusion Criteria

"patient not referred to functional restoration program by provider"

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Impact Score (PIS)	Baseline to 13 months	The Pain Impact Score (PIS) is based on the Defense and Veterans Pain Rating Scale (DVPRS), which measures 7-day average pain intensity (0-10 scale) and adaptive PROMIS pain interference and physical function using numeric, color, facial, and word descriptors and is validated. PROMIS T-scores are converted to compute the PIS, ranging from 8-50 with a higher score indicating greater pain.