Back to resultsGabapentin for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Gabapentin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring carpal tunnel syndrome, gabapentin
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.
Sites / Locations
- Prince of Wales Hospital
- North District Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Gabapentin
Placebo
Outcomes
Primary Outcome Measures
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
Secondary Outcome Measures
GSS at 2 weeks
Grip strength as functional assessment at 2 and 8 weeks
Tolerability
Full Information
NCT ID
NCT00137735
First Posted
August 29, 2005
Last Updated
October 30, 2007
Sponsor
Chinese University of Hong Kong
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00137735
Brief Title
Gabapentin for Carpal Tunnel Syndrome
Official Title
Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
carpal tunnel syndrome, gabapentin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Gabapentin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
300mg tds
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
tds
Primary Outcome Measure Information:
Title
Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
GSS at 2 weeks
Time Frame
2 weeks
Title
Grip strength as functional assessment at 2 and 8 weeks
Time Frame
2 weeks, 8 weeks
Title
Tolerability
Time Frame
throughout subject's participation in trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew CF Hui, FHKAM
Organizational Affiliation
Department of Medicine & Therapeutics, Faculty of Medicine, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
North District Hospital
City
Sheung Shui, New Territories
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Gabapentin for Carpal Tunnel Syndrome
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