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临床试验/NCT06898866
NCT06898866尚未招募不适用

An Effectiveness-Implementation Trial of Functional Restoration for Chronic Pain Management in Active Duty Military Personnel

The University of Texas Health Science Center at San Antonio0 个研究点目标入组 480 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
480
主要终点
Pain Impact Score (PIS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • "patient referred to functional restoration program by provider"

排除标准

  • "patient not referred to functional restoration program by provider"

结局指标

主要结局

Pain Impact Score (PIS)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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