Wearable Spine Health System for Military Readiness
Part of paid clinical trials in Luke Air Force Base, Arizona.
- Sponsor
- Ohio State University
- Study ID
- NCT05944354
- Status
- Enrolling By Invitation
Conditions
- Low Back Pain
- Neck Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Accepted
Study Details
The goal of this observational trial is to compare the health history and motion capabilities of participants with low back pain disorders to participants with healthy spines. The main question\[s\] it aims to answer are to: 1. Primary outcomes of this research effort include the development of composite measures or digital biomarkers to track functional recovery over time and predict duty or work status outcomes (return-to-full duty/work, limited duty/work restrictions or medical discharge/long-term disability). 2. Secondary outcomes of this research effort include characterization of motion assessment utility to predict reinjury risk and evaluate intervention effectiveness. In addition, exploratively, the investigators will determine biopsychosocial profiles of low back pain, and neck pain military populations to identify low back and neck pain phenotypes. Participants will complete questionnaires and wear a motion monitor that will assess the participant's back and/or neck. This session will be approximately 40-70 minutes. The research team will follow up with participants at 3 month, 6 months, and 1 year to complete a short series of questionnaires and a motion assessment test.
Key Dates
- Start date
- Sep 23, 2022
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2032
- Completion
- Dec 31, 2032
Study Design
- Enrollment
- 400 participants (estimated)
Arms
- Arm: Low Back PainSubjects with Low Back Pain
- Arm: Neck PainSubjects with Neck Pain
- Arm: ControlSubjects with healthy spines, who have no neck or low back pain
- Arm: Operational Air CrewSubjects that are in training aircrew program
Primary Outcome Measure
Predict Work Status [ Time Frame: 2030 ]
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Luke Air Force Base | Luke Air Force Base | Arizona | 85309 | - |
| Holloman Air Force Base | Holloman Air Force Base | New Mexico | 88330 | - |
| Seymour-Johnson Air Force Base | Seymour-Johnson Air Force Base | North Carolina | 27530 | - |
| The Ohio State University | Columbus | Ohio | 43210 | - |
| Wright-Patterson Air Force Research Laboratory | Wright-Patterson Air Force Base | Ohio | 45433 | - |
| Joint Base Langley- Eustis Air Force Base | Langley Air Force Base | Virginia | 23665 | - |
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