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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02382328
• Other study ID #: 265/14
• Status: Completed
• Phase: Phase 2
• First received: February 18, 2015
• Last updated: August 8, 2016
• Start date: February 2016
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Secretaria de Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• alpha lipoic acid
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.
• Placebo
Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.

Locations

Country	Name	City	State
Mexico	Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (2)

Di Geronimo G, Caccese AF, Caruso L, Soldati A, Passaretti U. Treatment of carpal tunnel syndrome with alpha-lipoic acid. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):133-9. — View Citation

Pajardi G, Bortot P, Ponti V, Novelli C. Clinical usefulness of oral supplementation with alpha-lipoic Acid, curcumin phytosome, and B-group vitamins in patients with carpal tunnel syndrome undergoing surgical treatment. Evid Based Complement Alternat Med — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes