| NCT ID | NCT05776771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University |
| Condition | Low Back Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,500 participants |
| Start Date | 2020-12-18 |
| Primary Completion | 2030-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 composite measures that differentiate between control and patient populations, predict injury or reinjury risk, identify low back and neck pain patient phenotypes, and evaluate treatment effectiveness. 2. Secondary outcomes of this research effort include an assessment of wearable motion sensor accuracy, characterization of motion assessment utility, biopsychosocial profiling of control and low back and neck pain patient populations, and differentiation of sincere and insincere motion assessment efforts. Participants will complete questionnaires and wear a motion monitor that will assess your 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, 1 year, 2 years, 5 years to complete a short series of questionnaires and a motion assessment test.
Eligibility Criteria
Controls/Insincere Inclusion Criteria * Age 18 and older * Able to stand for 20 minutes * Able to speak, read, and understand English Exclusion criteria: * Known pregnancy * Currently seeing or planning to see a medical provider for low back or neck pain * History of chronic low back or neck pain lasting longer than 3 months * Blind or severe uncorrected vision problems that prevent participant from reading a tablet or laptop screen * Deaf or hearing problems that prevent the participant from hearing verbal instructions * Actively being treated by a medical provider for concussion * Known severe spinal deformity requiring medical treatment (e.g. scoliosis) * Has been diagnosed by a medical provider with severe vertigo, fainting, narcolepsy, or balance disorders with high risk for falling * Any known fractures within the last 3 months that will interfere with the motion assessment * History of spine fracture * Current condition requiring immobilization or bracing of the spine * History