Gabapentin for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137735
• Other study ID #: IG-HK-GAB-01-02
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2005
• Last updated: October 30, 2007
• Start date: October 2003
• Est. completion date: December 2006

Study information

• Verified date: October 2007
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• Gabapentin
300mg tds

Other:
• placebo
tds

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Hong Kong	North District Hospital	Sheung Shui, New Territories

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Pfizer

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks		8 weeks
Secondary	GSS at 2 weeks		2 weeks
Secondary	Grip strength as functional assessment at 2 and 8 weeks		2 weeks, 8 weeks
Secondary	Tolerability		throughout subject's participation in trial