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Completed

NCT Number: NCT00137735

Gabapentin for Carpal Tunnel Syndrome

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital, Shatin, New Territories, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gabapentin

Drug

300mg tds

Placebo

Other

tds

Primary outcomes

  1. Global symptom score (GSS) recorded by a physician blinded to the allocation of treatment at 8 weeks

    Time frame: 8 weeks

Secondary outcomes

  1. GSS at 2 weeks

    Time frame: 2 weeks

  2. Grip strength as functional assessment at 2 and 8 weeks

    Time frame: 2 weeks, 8 weeks

  3. Tolerability

    Time frame: throughout subject's participation in trial

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Pfizer

Registry information

Official study title

Gabapentin for Carpal Tunnel Syndrome: A Randomised Controlled Trial

Important dates

Study start
2003
Study completion
2006
First posted
Aug 30, 2005
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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