Gabapentin for Carpal Tunnel Syndrome

Official Title: “Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial”

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

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • 300mg tds
• Other: placebo
  • tds

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Gabapentin
• Placebo Comparator: 2
  • Placebo

Primary Measures

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

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Chinese University of Hong Kong Other

Overall Clinical Trial Officials and Contacts

Andrew CF Hui, FHKAM Principal Investigator Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00137735

Study ID Number: IG-HK-GAB-01-02

ClinicalTrials.gov Identifier: NCT00137735

Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee