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- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Gabapentin for Carpal Tunnel Syndrome | |||
| Official Title ICMJE | Gabapentin 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 Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Carpal Tunnel Syndrome | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 150 | |||
| Original Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | December 2006 | |||
| Primary Completion Date | Not Provided | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Hong Kong | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00137735 | |||
| Other Study ID Numbers ICMJE | IG-HK-GAB-01-02 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Not Provided | |||
| Study Sponsor ICMJE | Chinese University of Hong Kong | |||
| Collaborators ICMJE | Pfizer | |||
| Investigators ICMJE |
| |||
| PRS Account | Chinese University of Hong Kong | |||
| Verification Date | October 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||