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

Phase 2

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: alpha lipoic acid; Drug: Placebo

• Registration Number: NCT02382328
• Lead Sponsor: Hospital Civil de Guadalajara

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-02-18
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Study Start: 2016-02
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alpha lipoic acid	alpha lipoic acid	600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release.
Placebo	Placebo	Oral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release.

Primary Outcome Measures

Name	Time	Method
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)	120 days after surgery	using nerve conduction studies to determine median sensory latency.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde; 🇲🇽 Guadalajara, Jalisco, Mexico