The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Location status: Recruiting
Location contact
Lindsay Hanes, BS, CCRC
CONTACT
William Marras, PhD, CPE
PRINCIPAL_INVESTIGATOR
NCT Number: NCT05776771
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Columbus, Ohio, 43210, United States
Location status: Recruiting
Lindsay Hanes, BS, CCRC
CONTACT
William Marras, PhD, CPE
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Controls/Insincere
Inclusion criteria
Exclusion criteria
Low Back Pain Patients
Inclusion criteria
Exclusion criteria
Neck Pain Patients
Inclusion criteria
Exclusion criteria
Time frame: 2030
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.
Time frame: 2030
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."
Time frame: 2030
The PROMIS-29 captures data from 7 domains ranging from Pain intensity, Pain Interference, Physical Function, Depression, Anixety, Fatigue, Sleep Disturbance, and Social Role
Time frame: 2030
PCS is used to characterize pain catastrophizing behaviors. It ranges between 0 - 24, with higher scores indicating more catastrophizing tendencies
Contact information is provided by the study sponsor or research team.
Ohio State University
Other
The Spine Phenome Project: Enabling Technology for Personalized Medicine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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