A Phase 2 interventional study of alpha lipoic acid and Placebo in Carpal Tunnel Syndrome, sponsored by Hospital Civil de Guadalajara. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-09.
Sponsored by Hospital Civil de Guadalajara · Phase 2, Interventional, and Treatment
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.
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.
589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.
Browse Carpal Tunnel Syndrome studies →Hospital Civil de Guadalajara is the lead sponsor of 39 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release.
Drug: alpha lipoic acid
Oral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release.
Drug: Placebo
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.
Also known as: thiocitic acid
Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
Also known as: inactive magnesium
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)
using nerve conduction studies to determine median sensory latency.
Time frame: 120 days after surgery
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.
Time frame: 120 days after surgery
Plan to share: Yes
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Hospital Civil de Guadalajara