Gabapentin for Carpal Tunnel Syndrome
This study has been completed.
Sponsor:
Chinese University of Hong Kong
Collaborator:
Pfizer
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00137735
First received: August 29, 2005
Last updated: October 30, 2007
Last verified: October 2007
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Purpose
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 Other: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial |
Resource links provided by NLM:
Genetics Home Reference related topics:
Charcot-Marie-Tooth disease
hereditary neuropathy with liability to pressure palsies
MedlinePlus related topics:
Carpal Tunnel Syndrome
U.S. FDA Resources
Further study details as provided by Chinese University of Hong Kong:
Primary Outcome Measures:
- Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks [ Time Frame: 8 weeks ]
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 ]
| Enrollment: | 150 |
| Study Start Date: | October 2003 |
| Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Gabapentin
|
Drug: Gabapentin
300mg tds
|
|
Placebo Comparator: 2
Placebo
|
Other: placebo
tds
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137735
Locations
| 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
| Principal Investigator: | Andrew CF Hui, FHKAM | Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00137735 History of Changes |
| Other Study ID Numbers: | IG-HK-GAB-01-02 |
| Study First Received: | August 29, 2005 |
| Last Updated: | October 30, 2007 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by Chinese University of Hong Kong:
|
carpal tunnel syndrome gabapentin |
Additional relevant MeSH terms:
|
Carpal Tunnel Syndrome 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 |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013