The Spine Phenome Project
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT05776771
- Status
- Recruiting
Conditions
- Low Back Pain
- Neck Pain
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- 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 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.
Key Dates
- Start date
- Dec 18, 2020
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2030
- Completion
- Dec 31, 2030
Study Design
- Enrollment
- 10,500 participants (estimated)
Arms
- Arm: Low Back PainSubjects with Low Back Pain
- Arm: Neck PainSubjects with Neck Pain
- Arm: Control/InsincereSubjects with healthy spines, who have no neck or low back pain
Primary Outcome Measure
Motion Index [ Time Frame: 2030 ]
Central Contacts
- Lindsay Hanes, BS, CCRC614-257-2294
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | William Marras, PhD, CPE (PRINCIPAL_INVESTIGATOR) |
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