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