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Gabapentin for Carpal Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00137735
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : October 31, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Gabapentin Other: placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
Study Start Date : October 2003
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
Gabapentin
 Drug: Gabapentin
300mg tds
Placebo Comparator: 2
Placebo
 Other: placebo
tds


Outcome Measures
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Primary Outcome Measures :
  1. Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. GSS at 2 weeks [ Time Frame: 2 weeks ]
  2. Grip strength as functional assessment at 2 and 8 weeks [ Time Frame: 2 weeks, 8 weeks ]
  3. Tolerability [ Time Frame: throughout subject's participation in trial ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00137735


Locations
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Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
North District Hospital
Sheung Shui, New Territories, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Pfizer
Investigators
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Principal Investigator: Andrew CF Hui, FHKAM Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
More Information
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ClinicalTrials.gov Identifier: NCT00137735    
Other Study ID Numbers: IG-HK-GAB-01-02
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: October 31, 2007
Last Verified: October 2007
Keywords provided by Chinese University of Hong Kong:
carpal tunnel syndrome
gabapentin
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Gabapentin
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents