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 range

18 Years – 64 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Predict Work Status

Timeframe: 2030

Trial details

NCT IDNCT05944354

SponsorOhio State University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2032-12-31

View on ClinicalTrials.gov More Low Back Pain trials