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临床试验/NCT02382328
NCT02382328已完成2 期

Effectiveness of Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Patients With Carpal Tunnel Syndrome Surgical Release

Hospital Civil de Guadalajara1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)

研究概览

简要总结

The main purpose of this study is to determine the effectiveness of use Alpha lipoic acid before and after surgical release of carpal tunnel syndrome. Controlled Clinical trial.

详细描述

The main purpose of this study is to determine the effectiveness of using an oral supplementation of alpha lipoid acid to improve clinical and electrophysiological recovery after carpal tunnel release surgery. This research is designed as a double blinded clinical trial, with a calculated sample size of 40 patients, divided in two groups of 20 (A placebo, B alpha lipoid acid). All patients will undergo open carpal tunnel release surgery, the procedure will be performed by an expert surgeon. A total of four visits will be performed as follows: T0. baseline 4 weeks before surgery, T1 immediately before surgery, T2: 4 weeks after surgery, T3: 8 weeks after surgery, T4: 12 weeks after surgery. The assessment to be perform on each visit includes: physical examination, Boston Questionary for Carpal Tunnel Syndrome. Nerve conduction study and ecographic evaluation will be performed on visits T0, T1 and T4. Statistical Analysis: Categorical variables will be assessed as counts and percent frequency and compared using the chi-squared test. All statistical analyses will be performed using the SPSS 21.0 package (SPSS Inc., Chicago, IL, USA). A two-tailed P value < 0.05 was considered statistically significant.

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
Double (Participant, Investigator)

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

  • clinical and electrophysiological diagnosis of carpal tunnel syndrome

排除标准

  • rheumatic diseases
  • distal radio or carpal fractures.
  • pregnant women
  • alpha lipoid acid allergy
  • local injections (ej. steroid carpal injections)
  • peripheral nervous system diseases (which may cause nerve conduction study abnormalities).

研究组 & 干预措施

alpha lipoic acid

Experimental

600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release.

干预措施: alpha lipoic acid (Drug)

Placebo

Placebo Comparator

Oral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release.

干预措施: Placebo (Drug)

结局指标

主要结局

median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)

时间窗: 120 days after surgery

using nerve conduction studies to determine median sensory latency.

次要结局

  • cross sectional area of median nerve (sonographic measurement to determine cross sectional area of median nerve.)(120 days after surgery)

研究者

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

Elisa Alejandra Monroy Guizar

Medico Especialista Medicina de Rehabilitación

Hospital Civil de Guadalajara

研究点 (1)

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