Clinical trial NCT01895621: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Entrapment Neuropathy, Carpal Tunnel
Compression Neuropathy, Carpal Tunnel
Median Neuropathy, Carpal Tunnel
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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 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.

Primary outcomes:
measure: Change in Median nerve conduction velocity
timeFrame: Preoperatively and 90 days after median nerve decompression
Secondary outcomes:
measure: Score with Boston questionnaire on carpal tunnel syndrome
timeFrame: Preoperatively and 90 days postdecompression
measure: Two point discrimination test on index finger pulp
timeFrame: Preoperatively and 90 days postdecompression
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Filippo Boriani, MD
role: PRINCIPAL_INVESTIGATOR
References: