Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.
Condition: Entrapment Neuropathy, Carpal Tunnel; Compression Neuropathy, Carpal Tunnel; Median Neuropathy, Carpal Tunnel
MeSH terms: Carpal Tunnel Syndrome; Nerve Compression Syndromes; Charcot-Marie-Tooth Disease; Hereditary Sensory and Motor Neuropathy; Median Neuropathy
Study type: Interventional
Phase: Phase 4

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:

        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.
    

Intervention name(s): Median nerve decompression at the wrist; Alpha lipoic acid post median nerve decompression
Intervention type(s): Procedure; Dietary Supplement
Intervention description(s): Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.; Daily supplementation of alpha lipoic acid
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment