NCT02382328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

4 months

First QC Date

February 18, 2015

Last Update Submit

August 8, 2016

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • cross sectional area of median nerve (sonographic measurement to determine cross sectional area of median nerve.)

    120 days after surgery

Study Arms (2)

alpha lipoic acid

EXPERIMENTAL

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

Drug: alpha lipoic acid

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

alpha lipoic acidDRUG

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
alpha lipoic acid
PlaceboDRUG

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
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical and electrophysiological diagnosis of carpal tunnel syndrome

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (2)

  • 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.

    PMID: 24563654RESULT

  • 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.

    PMID: 19499849RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Leonel Garcia, PhD

    University of Guadalajara

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medico Especialista Medicina de Rehabilitación

Study Record Dates

First Submitted

February 18, 2015

First Posted

March 6, 2015

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

ME(1)