Precise and Objective Identification of Bertolotti Syndrome Using Novel Kinematic Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.
研究概览
简要总结
The purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic VAS device, from twenty (20) Bertolotti Syndrome patients and twenty (20) non-Bertolotti low back pain patients during range-of-motion tasks. The assessments will be analyzed to determine the differences in kinematics and continuous pain scores between Bertolotti patients and non-Bertolotti low back pain patients.
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
- 否
入选标准
- •Lower Back Pain Cohort
- •Positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain
- •Age ≥ 18 years
- •Bertolotti's Syndrome Cohort
- •Positive diagnosis of Bertolotti's Syndrome
- •Age ≥ 18 years
- •Positive imaging for Bertolotti's Syndrome
- •Previous analgesic injection results
排除标准
- •Lower Back Pain Cohort
- •History of spinal deformity, previous spinal surgeries, spinal infections
- •Pregnant women
- •Bertolotti's Syndrome Cohort
- •History of spinal deformity, previous spinal surgeries, spinal infections
- •Pregnant women
研究组 & 干预措施
Bertolotti's Syndrome
Subjects with Bertolotti's Syndrome.
Non-Bertolotti's Lower Back Pain
Subjects without Bertolotti's Syndrome with lower back pain.
结局指标
主要结局
To identify Bertolotti's Syndrome-specific kinematic biomarkers using collected patient kinematic and real-time VAS data from range-of-motion tasks.
时间窗: 2025
次要结局
未报告次要终点
研究者
Michael Steinmetz, MD
Chairman, Department of Neurosurgery
The Cleveland Clinic