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

Condition	Intervention	Phase
Carpal Tunnel Syndrome	Drug: Gabapentin (drug)	Phase III

Further Study Details: 

Primary Outcomes: Global Symptom Score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks.
Secondary Outcomes: 1) GSS at 2 weeks; 2) Grip strength as functional assessment at 2 and 8 weeks; 3) Tolerability
Expected Total Enrollment:  150

A variety of treatment options exist at present for carpal tunnel syndrome (CTS) with no universal agreement. Recent report 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; Neurotin, 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00137735

Andrew CF Hui, FHKAM      852-2632-2211    huicf@yahoo.com
Evelyn Yu, BSc      852-2632-3856    evelyn.yu@cuhk.edu.hk

Hong Kong
      Prince of Wales Hospital, Shatin, New Territories,  Hong Kong; Recruiting
      North District Hospital, Sheung Shui, New Territories,  Hong Kong; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  IG-HK-GAB-01-02
Last Updated:  August 29, 2005
Record first received:  August 29, 2005
ClinicalTrials.gov Identifier:  NCT00137735
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-30