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

Median Neuropathy, Carpal Tunnel Clinical Trial

Official title:

The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895621
• Other study ID #: TUNNEL ALFALIPO
• Status: Completed
• Phase: Phase 4
• First received: June 25, 2013
• Last updated: June 23, 2015
• Start date: March 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2015
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Charcot-Marie-Tooth Disease
• Compression Neuropathy, Carpal Tunnel
• Entrapment Neuropathy, Carpal Tunnel
• Hereditary Sensory and Motor Neuropathy
• Median Neuropathy
• Median Neuropathy, Carpal Tunnel
• Nerve Compression Syndromes

Intervention

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

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Median nerve conduction velocity		Preoperatively and 90 days after median nerve decompression	No
Secondary	Score with Boston questionnaire on carpal tunnel syndrome		Preoperatively and 90 days postdecompression	No
Secondary	Two point discrimination test on index finger pulp		Preoperatively and 90 days postdecompression	No