Gabapentin for Carpal Tunnel Syndrome

Phase 3

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: placebo; Drug: Gabapentin

• Registration Number: NCT00137735
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-30
• Study Completion: 2006-12
• Status Verified: 2007-10
• Last Update Submitted: 2007-10-30
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Placebo
1	Gabapentin	Gabapentin

Primary Outcome Measures

Name	Time	Method
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
Grip strength as functional assessment at 2 and 8 weeks	2 weeks, 8 weeks
GSS at 2 weeks	2 weeks
Tolerability	throughout subject's participation in trial

Trial Locations

Locations (2)

Prince of Wales Hospital; 🇭🇰 Shatin, New Territories, Hong Kong

North District Hospital; 🇭🇰 Sheung Shui, New Territories, Hong Kong