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Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01895621
First Posted: July 10, 2013
Last Update Posted: June 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
June 25, 2013
July 10, 2013
June 24, 2015
March 2013
December 2014   (Final data collection date for primary outcome measure)
Change in Median nerve conduction velocity [ Time Frame: Preoperatively and 90 days after median nerve decompression ]
Same as current
Complete list of historical versions of study NCT01895621 on ClinicalTrials.gov Archive Site
  • Score with Boston questionnaire on carpal tunnel syndrome [ Time Frame: Preoperatively and 90 days postdecompression ]
  • Two point discrimination test on index finger pulp [ Time Frame: Preoperatively and 90 days postdecompression ]
Same as current
Not Provided
Not Provided
 
Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.

The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.

Patients will be enrolled with proven carpal tunnel syndrome. By means of randomization, patients will be placed into one of two groups:

Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.

Group B: surgical decompression of the median nerve followed by treatment with placebo

The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.

The postoperative course of the decompression of the median nerve in the carpal tunnel syndrome can sometimes be complicated by pain, paresthesias and other unpleasant symptoms, or may be characterized by a slow recovery of nerve function, often also because of a prolonged illness prior to the decompression, causing extensive damage to the nerve, including demyelination, or other morphofunctional deficits. For this reason it could be particularly useful to associate a dietary supplement as a support to the structure and physiology of nerve in the post-decompression period. In this respect, the alpha-lipoic acid molecule seems to be a particularly interesting. Lipoic acid is considered to be a powerful and effective antioxidant with neuroprotective and neurotrophic properties. Dietary supplementation with lipoic acid helps reduce the damage to the nervous structure. Its action as a dietary supplement may positively modulate and accelerate healing after decompression of the median nerve.

The aim of the study is to explore any possible effects of this molecule in the postoperative period after decompression of the median nerve at the wrist.

Patients will be enrolled with proven carpal tunnel syndrome, confirmed by a careful examination including the diagnostic maneuvers Phalen, Tinel and antiPhalen. By means of randomization, patients will be placed into one of two groups:

Group A: surgical decompression of the median nerve followed by alpha lipoic acid, 800 mg daily for 40 days.

Group B: surgical decompression of the median nerve followed by treatment with placebo Surgical treatment is performed in both groups according to the standard for this type of intervention, and within 90 days after joining the waiting list.

Patients will be excluded in case of recurrent carpal tunnel syndrome. Other causes of exclusion will be carpal tunnel syndrome associated with diabetes mellitus or rheumatoid hand or secondary to other causes, uncooperative patients with poor compliance with treatment, patients with hypersensitivity to the product or one of its components, patients with pace-maker as this does not allow nerve conduction studies and electromyography, needed to evaluate pre and post treatment.

The primary endpoint of the study will be Nerve conduction velocity at 3 months after surgery after 50 days of discontinuing treatment with alpha lipoic acid (TIOBEC) / PLACEBO.

Secondary endpoints:

  1. assessment of pain reported by the patient using the VAS (Visual Analogue Scale).
  2. Clinical evaluation objective (presence of paresthesia and two-point discrimination on the tip of the index finger, and subjective (symptom description by the patient by means of tests and Levine-Katz questionnaire) at 3 and 6 months.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Entrapment Neuropathy, Carpal Tunnel
  • Compression Neuropathy, Carpal Tunnel
  • Median Neuropathy, Carpal Tunnel
  • Procedure: Median nerve decompression at the wrist
    Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.
  • Dietary Supplement: Alpha lipoic acid post median nerve decompression
    Daily supplementation of alpha lipoic acid
  • Experimental: Lipoic
    Median nerve decompression at the wrist, followed by Alpha lipoic acid post median nerve decompression: lipoic acid, 800 mg daily for 40 days from the day of the operation, tablets.
    Interventions:
    • Procedure: Median nerve decompression at the wrist
    • Dietary Supplement: Alpha lipoic acid post median nerve decompression
  • Placebo Comparator: placebo
    Median nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid
    Intervention: Procedure: Median nerve decompression at the wrist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
June 2015
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

• Patients suffering from primary carpal tunnel syndrome, confirmed clinically and with nerve conduction studies

Exclusion Criteria:

  • Recurrent or secondary carpal tunnel syndromes.
  • Diabetic patients.
  • Patients with pace-makers.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01895621
TUNNEL ALFALIPO
No
Not Provided
Not Provided
Istituto Ortopedico Rizzoli
Istituto Ortopedico Rizzoli
Not Provided
Principal Investigator: Filippo Boriani, MD Istituto Ortopedico Rizzoli
Istituto Ortopedico Rizzoli
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP