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| ID | Type | Description | Link |
|---|---|---|---|
| 4UH3AR076729-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Back Pain | Subjects with Low Back Pain | ||
| Neck Pain | Subjects with Neck Pain | ||
| Control/Insincere | Subjects with healthy spines, who have no neck or low back pain |
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| Measure | Description | Time Frame |
|---|---|---|
| Motion Index | Composite functional score ranging from 0 - 100, with higher scores indicating healthier function. This is a composite metric derived from a standardized sensor-enabled spinal motion assessment. Motion features extracted from the motion assessment are benchmarked against a normative population. | 2030 |
| Patient's Global Impression of Change (PGIC) | PGIC is a 7 point scale indicating a patient's preception of overall improvement after treatment. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse." | 2030 |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-29 | The PROMIS-29 captures data from 7 domains ranging from Pain intensity, Pain Interference, Physical Function, Depression, Anixety, Fatigue, Sleep Disturbance, and Social Role | 2030 |
| Pain Catastrophizing scale (PCS-6) |
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Controls/Insincere
Inclusion Criteria
Exclusion criteria:
Low Back Pain Patients
Inclusion Criteria
Exclusion criteria:
Neck Pain Patients
Inclusion Criteria
Exclusion criteria:
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There are 3 different study populations: Controls/Insincere, Low Back Pain, and Neck Pain
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Hanes, BS, CCRC | Contact | 614-257-2294 | lindsay.hanes@osumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37813527 | Derived | Mageswaran P, Dufour J, Aurand A, Knapik G, Hani H, Blakaj DM, Khan S, Hussain N, Tiwari M, Vallabh J, Weaver T, Marras WS. Wearable motion-based platform for functional spine health assessment. Reg Anesth Pain Med. 2024 Jul 8;49(7):518-527. doi: 10.1136/rapm-2023-104840. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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PCS is used to characterize pain catastrophizing behaviors. It ranges between 0 - 24, with higher scores indicating more catastrophizing tendencies
| 2030 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |