Carpal Tunnel Syndrome
Conditions
Keywords
carpal tunnel syndrome, gabapentin
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.
Interventions
DRUGGabapentin
300mg tds
OTHERplacebo
tds
Sponsors
Pfizer
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Grip strength as functional assessment at 2 and 8 weeks | 2 weeks, 8 weeks |
| Tolerability | throughout subject's participation in trial |
| GSS at 2 weeks | 2 weeks |
Countries
Hong Kong
Outcome results
None listed