Carpal Tunnel Syndrome
Conditions
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.
Interventions
DRUGalpha 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.
DRUGPlacebo
Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Outcome results
None listed