Gabapentin for Carpal Tunnel Syndrome

Condition(s) targeted: Carpal Tunnel Syndrome

Intervention: Gabapentin (Drug); placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Chinese University of Hong Kong

Official(s) and/or principal investigator(s):
Andrew CF Hui, FHKAM, Principal Investigator, Affiliation: Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong

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

Official title: Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks

Secondary outcome:

GSS at 2 weeks

Grip strength as functional assessment at 2 and 8 weeks

Tolerability

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Prince of Wales Hospital, Shatin, New Territories, Hong Kong

North District Hospital, Sheung Shui, New Territories, Hong Kong

Starting date: October 2003
Ending date: December 2006
Last updated: October 30, 2007