Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Carpal Tunnel Syndrome Undergoing Surgical Release

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: alpha lipoic acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical and electrophysiological diagnosis of carpal tunnel syndrome Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: alpha lipoic acid<br>600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release. | Drug: alpha lipoic acid<br>* comparison of 600mg/24h oral, alpha lipoid acid, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.<br>* Other names: thiocitic acid;|
| Placebo Comparator: Placebo<br>Oral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release. | Drug: Placebo<br>* Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.<br>* Other names: inactive magnesium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median nerve sensory latency (using nerve conduction studies to determine median sensory latency.) | using nerve conduction studies to determine median sensory latency. | 120 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cross sectional area of median nerve (sonographic measurement to determine cross sectional area of median nerve.) | sonographic measurement to determine cross sectional area of median nerve. | 120 days after surgery |