Gabapentin for Carpal Tunnel Syndrome

The Chinese University of Hong Kong

Status and phase: Completed; Phase 3

Conditions: Carpal Tunnel Syndrome

Treatments: Other: placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00137735

IG-HK-GAB-01-02

Details and patient eligibility

About

The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).

Full description

A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent reports suggested that untreated CTS might improve or remain stationary. In this respect, treatment directing towards symptom suppression alone may have a role in the initial management of CTS. Gabapentin (1-[aminomethyl]-cyclohexaneacetic acid; Neurontin, Pfizer) is an effective drug for treatment of neuropathic pain and has been reported to be effective in case series for the treatment of CTS with relatively benign side effects profile. The purpose of this study was to evaluate the safety and efficacy of gabapentin in the treatment of CTS.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sensory symptoms over median nerve distribution for more than three months.
• Confirmatory electrophysiologic results defined as prolonged median nerve distal motor latencies (DML) > 4 ms or median-ulnar palmer sensory latency differences > 0.5 ms.

Exclusion criteria

• Patients with evidence of severe CTS: fibrillation potentials or reinnervation on needle examination of the abductor pollicis brevis muscle or clinical examination showing wastage of the thenar muscles. (These patients were referred for surgical decompression on presentation.)
• Clinical or electrophysiological evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as proximal median neuropathy, cervical radiculopathy, or significant polyneuropathy.
• Known epilepsy.
• Patients who have received previous steroid injection or oral steroid therapy for CTS.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Gabapentin

Treatment:

Drug: Gabapentin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo