Efficacy of Operative Versus Conservative Treatment in Proximal Median Nerve Compression
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Global improvement
研究概览
简要总结
A multi-center randomized controlled clinical trial which determines the efficacy of proximal median nerve release in patients with persistent proximal median nerve compression. The primary outcome is patient reported improvement of symptoms on a 7-point Likert scale at 6 months after the randomization to treatment group.
详细描述
Carpal tunnel surgery is one of the most common surgeries in upper extremity. Most patients benefit from carpal tunnel surgery, but some patients complain weakness and pain symptoms after surgery. According to a case series by Özdemir et al. (2020), after carpal tunnel surgery up to 13% of patients were diagnosed with proximal median nerve compression. Proximal median nerve compression is a poorly known and recognized condition that is likely to be underdiagnosed. Surgical treatment has become more common in recent years even though the effect of surgical treatment is unclear at the moment.
The planned multi-center randomized controlled clinical trial determines the efficacy of proximal median nerve release in patients with persistent proximal median nerve compression. The primary outcome is patient reported improvement of symptoms on a 7-point Likert scale at 6 months after the randomization to treatment group.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed PMNC
- •If the patient has clinically and electrodiagnostically confirmed carpal tunnel syndrome, at least 6 months must have passed since surgical treatment
- •Age 18 or over
- •Ability to understand Finnish
- •Ability to complete electronic questionnaires independently
- •Willingness to participate in research and follow research instructions
- •Provision of informed consent from the participant
排除标准
- •Nerve root disorder findings in ENMG
- •Thoracic outlet syndrome, TOS
- •Other neurological condition that causes upper limb symptoms such as MS, previous nerve injury
- •Active rheumatoid arthritis or any other active inflammatory joint disease that affects hand function
- •Significant compression symptoms of another peripheral nerve in association with PMNC
- •Other upper extremity operation performed less than 6 months ago
- •Another disease or condition that accounts for most of the patient's symptoms
- •Other known reasons that may prevent participation or implementation of treatment during the study
研究组 & 干预措施
Proximal median nerve release
Operative treatment: proximal median nerve release
干预措施: Proximal median nerve release (Procedure)
Proximal median nerve release
Operative treatment: proximal median nerve release
干预措施: Physiotherapy (Other)
Physiotherapy
Conservative treatment: physiotherapy
干预措施: Physiotherapy (Other)
结局指标
主要结局
Global improvement
时间窗: 6 months
Question to patient (Likert scale): Have your symptoms been better in the last week than before the beginning of treatment? (much better; better; a little better; no change; a little worse; worse; much worse)
次要结局
- Global improvement(3 and 6 months, and 1, 2, and 5 years)
- Global improvement(3 months, and 1, 2, 5 years)
- The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS)(3 and 6 months, and 1, 2, and 5 years)
- The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS)(3 and 6 months, and 1, 2, and 5 years)
- Questions on proximal nerve symptoms(3 and 6 months, and 1, 2, and 5 years)
- The use of painkillers(3 and 6 months, and 1, 2, and 5 years)
- EUROQOL EQ-5D-5L(3 and 6 months, and 1, 2, and 5 years)
- Grip strength(6 months)
- Patient reported wrist and hand evaluation (PRWHE)(3 and 6 months, and 1, 2, and 5 years)
- Patient accepted symptom state (PASS)(3 and 6 months, and 1, 2, and 5 years)
- Return to work(3 and 6 months, and 1, 2, and 5 years)
- Adverse effects(3 and 6 months, and 1, 2, and 5 years)
- Questionnaire on the need for treatment(3 and 6 months, and 1, 2, and 5 years)
- Pinch strength(6 months)
- Standard two-point discrimination(6 months)