Postoperative Alpha Lipoic Acid in the Carpal Tunnel Syndrome: a Randomized Controlled Trial.

NCT01895621 | Completed Phase 4

• 1 other identifier: TUNNEL ALFALIPO
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Entrapment Neuropathy, Carpal Tunnel; Compression Neuropathy, Carpal Tunnel; Median Neuropathy, Carpal Tunnel

Outcome Measures

Primary Outcomes (1)

• Change in Median nerve conduction velocity

  Preoperatively and 90 days after median nerve decompression

Secondary Outcomes (2)

• Score with Boston questionnaire on carpal tunnel syndrome

  Preoperatively and 90 days postdecompression

• Two point discrimination test on index finger pulp

  Preoperatively and 90 days postdecompression

Study Arms (2)

Lipoic

EXPERIMENTAL

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; Dietary Supplement: Alpha lipoic acid post median nerve decompression

placebo

PLACEBO COMPARATOR

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

Interventions

Median nerve decompression at the wrist PROCEDURE

Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.

Lipoic; placebo

Alpha lipoic acid post median nerve decompression DIETARY_SUPPLEMENT

Daily supplementation of alpha lipoic acid

Lipoic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from primary carpal tunnel syndrome, confirmed clinically and with nerve conduction studies

You may not qualify if:

• Recurrent or secondary carpal tunnel syndromes.
• Diabetic patients.
• Patients with pace-makers.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Filippo Boriani, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: July 10, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 24, 2015

Record last verified: 2015-01

Locations

IT (1)