Identification and Validation of Non-invasive Mechanomyography as a Valuable Predictor of Clinical Course and Long-term Prognosis for Cubital Tunnel Syndrome and Peroneal Nerve Decompression Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- PROMIS Questionnaire
研究概览
简要总结
The study will be a non-blinded two cohort design consisting only of symptomatic patients with CuTS or compressive peroneal neuropathy or in need of peroneal nerve decompression. The first cohort will be - patients with CuTS. Evaluation of each CuTS patient will include assessment by the treating surgeon and a certified hand therapist. Patients who have clinical examination and history consistent with a diagnosis of CuTS based on subjective and functional assessment outlined below will be consented to this study. The second cohort will be patients in need PND for compressive neuropathy of peroneal nerve. PND patients will be evaluated by clinical exam and have imaging with high resolution ultrasound or MRI negative for mass lesion.
详细描述
Visit 1
- Exam and discussion with surgeon
- Exam and testing with Occupational Hand Therapist (Standard of Care) as described above. (CuTS cohort)
- Diagnostic studies (EMG/NCT) (Standard of Care)
- Questionnaires - PROMIS and ODI
Visit 2
- Standard of Care surgery
- During surgery, the surgeon will perform an MMG immediately pre-decompression and immediately post-decompression of the nerve. This will entail placing a sensor and probe on the nerve that will be decompressed.
Visit 3 and 4 (6 week and 3 month post-op)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients who have a diagnosis of Cubital Tunnel Syndrome or Compressive Peroneal Nerve Neuropathy and will be undergoing a decompressive surgery.
排除标准
- •Patients under 18 years of age
- •Patients who are unable to return for follow-up evaluation.
结局指标
主要结局
PROMIS Questionnaire
时间窗: 6 months
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. Scores range from 0-50 with a higher indicating a better outcome.
次要结局
- Oswestry Disability Index (ODI)(6 months)
研究者
Wilson Z. Ray
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.