Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial. - Full Text View

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome

Drug Information available for: Thioctic acid Lipoic acid

Genetic and Rare Diseases Information Center resources: Charcot-Marie-Tooth Disease Hereditary Neuropathy With Liability to Pressure Palsy Roussy Levy Syndrome

U.S. FDA Resources

Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:

Change in Median nerve conduction velocity [ Time Frame: Preoperatively and 90 days after median nerve decompression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Score with Boston questionnaire on carpal tunnel syndrome [ Time Frame: Preoperatively and 90 days postdecompression ] [ Designated as safety issue: No ]
Two point discrimination test on index finger pulp [ Time Frame: Preoperatively and 90 days postdecompression ] [ Designated as safety issue: No ]


Enrollment:	64
Study Start Date:	March 2013
Study Completion Date:	June 2015
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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:

assessment of pain reported by the patient using the VAS (Visual Analogue Scale).
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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895621

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


Responsible Party:	Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:	NCT01895621 History of Changes
Other Study ID Numbers:	TUNNEL ALFALIPO
Study First Received:	June 25, 2013
Last Updated:	June 23, 2015
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:


Carpal Tunnel Syndrome Nerve Compression Syndromes Charcot-Marie-Tooth Disease Hereditary Sensory and Motor Neuropathy Median Neuropathy Mononeuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases 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

ClinicalTrials.gov processed this record on September 26, 2016