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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
alpha lipoic acid
Placebo
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

alpha lipoic acid

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)
using nerve conduction studies to determine median sensory latency.

Secondary Outcome Measures

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.

Full Information

First Posted
February 18, 2015
Last Updated
August 8, 2016
Sponsor
Hospital Civil de Guadalajara
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1. Study Identification

Unique Protocol Identification Number
NCT02382328
Brief Title
Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Carpal Tunnel Syndrome Undergoing Surgical Release
Official Title
Effectiveness of Alpha Lipoic Acid on Clinical and Electrophysiological Recovery in Patients With Carpal Tunnel Syndrome Surgical Release
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
alpha lipoic acid
Arm Type
Experimental
Arm Description
600mg/24 oral pills alpha lipoic acid 28 days before and 120 days after carpal tunnel release.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral pills of mangensium inactivated 28 days before and 120 days after carpal tunnel release.
Intervention Type
Drug
Intervention Name(s)
alpha lipoic acid
Other Intervention Name(s)
thiocitic acid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
inactive magnesium
Intervention Description
Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
Primary Outcome Measure Information:
Title
median nerve sensory latency (using nerve conduction studies to determine median sensory latency.)
Description
using nerve conduction studies to determine median sensory latency.
Time Frame
120 days after surgery
Secondary Outcome Measure Information:
Title
cross sectional area of median nerve (sonographic measurement to determine cross sectional area of median nerve.)
Description
sonographic measurement to determine cross sectional area of median nerve.
Time Frame
120 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonel Garcia, PhD
Organizational Affiliation
University of Guadalajara
Official's Role
Study Director
Facility Information:
Facility Name
Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
24563654
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. 2014;2014:891310. doi: 10.1155/2014/891310. Epub 2014 Jan 19.
Results Reference
result
PubMed Identifier
19499849
Citation
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.
Results Reference
result

Learn more about this trial

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

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