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

Hospital Civil de Guadalajara

Status and phase: Completed; Phase 2

Conditions: Carpal Tunnel Syndrome

Treatments: Drug: alpha lipoic acid; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02382328

265/14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups, including a placebo group

alpha lipoic acid

Experimental group

Description:

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

Treatment:

Drug: alpha lipoic acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo