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临床试验/NCT05776771
NCT05776771招募中不适用

The Spine Phenome Project: Enabling Technology for Personalized Medicine

Ohio State University1 个研究点 分布在 1 个国家目标入组 10,500 人开始时间: 2020年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,500
试验地点
1
主要终点
Motion Index

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Motion Index

时间窗: 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.

Patient's Global Impression of Change (PGIC)

时间窗: 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."

次要结局

  • PROMIS-29(2030)
  • Pain Catastrophizing scale (PCS-6)(2030)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Marras

Director of SRI

Ohio State University

研究点 (1)

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