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 Pain
    Subjects with Low Back Pain
  • Arm: Neck Pain
    Subjects with Neck Pain
  • Arm: Control
    Subjects with healthy spines, who have no neck or low back pain
  • Arm: Operational Air Crew
    Subjects that are in training aircrew program

Primary Outcome Measure

Predict Work Status [ Time Frame: 2030 ]

Locations (6)

FacilityCityStateZIPSite coordinators
Luke Air Force BaseLuke Air Force BaseArizona85309-
Holloman Air Force BaseHolloman Air Force BaseNew Mexico88330-
Seymour-Johnson Air Force BaseSeymour-Johnson Air Force BaseNorth Carolina27530-
The Ohio State UniversityColumbusOhio43210-
Wright-Patterson Air Force Research LaboratoryWright-Patterson Air Force BaseOhio45433-
Joint Base Langley- Eustis Air Force BaseLangley Air Force BaseVirginia23665-

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