MedDataX Logo

Gabapentin for Carpal Tunnel Syndrome

NCT ID: NCT00137735

Last Updated: 2007-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Carpal Tunnel Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

carpal tunnel syndrome gabapentin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

300mg tds

2

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

tds

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gabapentin

300mg tds

Intervention Type DRUG

placebo

tds

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrew CF Hui, FHKAM

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prince of Wales Hospital

Shatin, New Territories, , Hong Kong

Site Status

North District Hospital

Sheung Shui, New Territories, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IG-HK-GAB-01-02

Identifier Type: -

Identifier Source: org_study_id