Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Primary Purpose
Entrapment Neuropathy, Carpal Tunnel, Compression Neuropathy, Carpal Tunnel, Median Neuropathy, Carpal Tunnel
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Median nerve decompression at the wrist
Alpha lipoic acid post median nerve decompression
Sponsored by
About this trial
This is an interventional treatment trial for Entrapment Neuropathy, Carpal Tunnel
Eligibility 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.
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lipoic
placebo
Arm Description
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.
Median nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid
Outcomes
Primary Outcome Measures
Change in Median nerve conduction velocity
Secondary Outcome Measures
Score with Boston questionnaire on carpal tunnel syndrome
Two point discrimination test on index finger pulp
Full Information
NCT ID
NCT01895621
First Posted
June 25, 2013
Last Updated
June 23, 2015
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT01895621
Brief Title
Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Official Title
The Association of Alpha Lipoic Acid to the Median Nerve Decompression in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Entrapment Neuropathy, Carpal Tunnel, Compression Neuropathy, Carpal Tunnel, Median Neuropathy, Carpal Tunnel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lipoic
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Median nerve decompression at the wrist, followed by placebo in the same form frequency and duration as alpha lipoic acid
Intervention Type
Procedure
Intervention Name(s)
Median nerve decompression at the wrist
Intervention Description
Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha lipoic acid post median nerve decompression
Intervention Description
Daily supplementation of alpha lipoic acid
Primary Outcome Measure Information:
Title
Change in Median nerve conduction velocity
Time Frame
Preoperatively and 90 days after median nerve decompression
Secondary Outcome Measure Information:
Title
Score with Boston questionnaire on carpal tunnel syndrome
Time Frame
Preoperatively and 90 days postdecompression
Title
Two point discrimination test on index finger pulp
Time Frame
Preoperatively and 90 days postdecompression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Boriani, MD
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
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