By InvitationNot Applicable

Wearable Spine Health System for Military Readiness

United States400 participantsStarted 2022-09-23

Plain-language summary

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.

Who can participate

Age range18 Years – 64 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Control Cohort * Ages 18-64 * Able to stand for at least 25 minutes * Able to speak, read, and understand English Low Back Pain Cohort * Age 18-64 * Able to stand for at least 15 minutes * Able to speak, read, and understand English * Within the last 3 months, an episode of low back pain lasting longer than 7 days and/or seeing a health care provider for low back pain and/or on duty/work restriction due to low back pain. Neck Pain Cohort * Ages 18-64 * Able to stand for at least 15 minutes * Able to speak, read, and understand English * Within the last 3 months, an episode of neck pain lasting longer than 7 days and/or seeing a health care provider for neck pain and/or on duty/work restriction due to neck pain. Operational Air crew Cohort * Ages 18-55 * Able to stand for at least 25 minutes * Able to speak, read, and understand English * Ability to participate in cervical and back endurance training programs as part of standard operations Exclusion Criteria: Control Cohort * Known pregnancy * Within the last 3 months, back or neck pain lasting longer than 7 days and/or seeing a health care provider for low back or neck pain and/or on duty/work restriction due to low back or neck pain. * Actively being treated by a medical provider for concussion or traumatic brain injury * Known severe spine curvature or deformity requiring medical treatment (e.g. scoliosis) * Has been diagnosed by a medical provider with severe vertigo, fainting, narcolepsy, or…

What they're measuring

Predict Work Status

Timeframe: 2030

Trial details

NCT IDNCT05944354

SponsorOhio State University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2032-12-31