Gabapentin for Carpal Tunnel Syndrome

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to determine whether gabapentin is safe and effective in the treatment of carpal tunnel syndrome (CTS).
ConditionCarpal Tunnel Syndrome
InterventionDrug: Gabapentin
Other: placebo
PhasePhase 3
SponsorChinese University of Hong Kong
Responsible PartyChinese University of Hong Kong
ClinicalTrials.gov IdentifierNCT00137735
First ReceivedAugust 29, 2005
Last UpdatedOctober 30, 2007
Last verifiedOctober 2007

Tracking Information[ + expand ][ + ]

First Received DateAugust 29, 2005
Last Updated DateOctober 30, 2007
Start DateOctober 2003
Estimated Primary Completion DateDecember 2006
Current Primary Outcome MeasuresGlobal symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks [Time Frame: 8 weeks]
Current Secondary Outcome 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]

Descriptive Information[ + expand ][ + ]

Brief TitleGabapentin for Carpal Tunnel Syndrome
Official TitleGabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionCarpal Tunnel Syndrome
InterventionDrug: Gabapentin
300mg tds
Other: placebo
tds
Study Arm (s)
  • Active Comparator: 1
    Gabapentin
  • Placebo Comparator: 2
    Placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment150
Estimated Completion DateDecember 2006
Estimated Primary Completion DateNot Provided
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesHong Kong

Administrative Information[ + expand ][ + ]

NCT Number NCT00137735
Other Study ID NumbersIG-HK-GAB-01-02
Has Data Monitoring CommitteeNot Provided
Information Provided ByChinese University of Hong Kong
Study SponsorChinese University of Hong Kong
CollaboratorsPfizer
Investigators Principal Investigator: Andrew CF Hui, FHKAM Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
Verification DateOctober 2007

Locations[ + expand ][ + ]

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