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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Entrapment Neuropathy, Carpal Tunnel; Compression Neuropathy, Carpal Tunnel; Median Neuropathy, Carpal Tunnel	Procedure: Median nerve decompression at the wrist; Dietary Supplement: Alpha lipoic acid post median nerve decompression	Phase 4

Detailed 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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	64 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Study Start Date :	March 2013
Actual Primary Completion Date :	December 2014
Actual Study Completion Date :	June 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.	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
Placebo Comparator: placebo; Median nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid	Procedure: Median nerve decompression at the wrist; Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Change in Median nerve conduction velocity [ Time Frame: Preoperatively and 90 days after median nerve decompression ]

Secondary Outcome Measures :

1. Score with Boston questionnaire on carpal tunnel syndrome [ Time Frame: Preoperatively and 90 days postdecompression ]
2. Two point discrimination test on index finger pulp [ Time Frame: Preoperatively and 90 days postdecompression ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136

Sponsors and Collaborators

Istituto Ortopedico Rizzoli

Investigators

Principal Investigator:	Filippo Boriani, MD	Istituto Ortopedico Rizzoli

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:	NCT01895621 History of Changes
Other Study ID Numbers:	TUNNEL ALFALIPO
First Posted:	July 10, 2013
Last Update Posted:	June 24, 2015
Last Verified:	January 2015

Additional relevant MeSH terms:

Carpal Tunnel Syndrome; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Median Neuropathy; Neuromuscular Diseases; Nervous System Diseases; Mononeuropathies; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Nervous System Malformations; Heredodegenerative Disorders, Nervous System	Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Genetic Diseases, Inborn; Thioctic Acid; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Vitamin B Complex; Vitamins; Micronutrients; Growth Substances