The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
研究概览
简要总结
The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres
- •Normal two point discrimination
- •Over the age of 18 and under the age of 65
排除标准
- •Peripheral neuropathy of the median nerve secondary to trauma
- •Presence of thoracic outlet syndrome
- •Presence of cervical disk disease
- •Under the age of 18 and over the age of 65
研究组 & 干预措施
Carpal Tunnel Release only
Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.
干预措施: Pronator Teres Release (Procedure)
Carpal Tunnel and Pronator Teres Release
Patients enrolled in this arm of the study will have both surgical procedures performed at the same time
干预措施: dual compression release (Procedure)
Carpal Tunnel Release only
Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.
干预措施: dual compression release (Procedure)
Carpal Tunnel Release only
Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.
干预措施: median nerve release only (Procedure)
结局指标
主要结局
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
时间窗: 12 months
The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.
次要结局
未报告次要终点