Trial record 1 of 88 for:    "Carpal Tunnel Syndrome"
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Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Istituto Ortopedico Rizzoli
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01895621
First received: June 25, 2013
Last updated: June 10, 2014
Last verified: July 2013
  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:


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 ]

Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: March 2015
Estimated 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:

  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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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

Contacts
Contact: Filippo Boriani, MD 00393297604660 filippo.boriani@ior.it

Locations
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Filippo Boriani    0    filippo.boriani@ior.it   
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
Investigators
Principal Investigator: Filippo Boriani, MD Istituto Ortopedico Rizzoli
  More Information

No publications provided

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 10, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Demyelinating Diseases
Polyneuropathies
Neurologic Manifestations
Neurotoxicity Syndromes
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
Congenital Abnormalities
Genetic Diseases, Inborn
Signs and Symptoms
Poisoning
Substance-Related Disorders
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014