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Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial
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Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial
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Journal Article
Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial
2017
Overview
Background
Postherpetic neuralgia (PHN) is a chronic neuropathic pain that results from alterations of the peripheral nervous system in areas affected by the herpes zoster virus. The symptoms include pain, paresthesia, dysesthesia, hyperalgesia, and allodynia. Despite the availability of pharmacological treatments to control these symptoms, no treatments are available to control the underlying pathophysiology responsible for this disabling condition.
Methods/design
Patients with herpes zoster who are at least 50 years old and have a pain score of 4 or higher on a visual analogue scale (VAS) will be recruited. The aim is to recruit 134 patients from the practices of general physicians. Participants will be randomized to receive gabapentin to a maximum of 1800 mg/day for 5 weeks or placebo. Both arms will receive 1000-mg caplets of valacyclovir three times daily for 7 days (initiated within 72 h of the onset of symptoms) and analgesics as needed. The primary outcome measure is the percentage of patients with a VAS pain score of 0 at 12 weeks from rash onset. The secondary outcomes measures are changes in quality of life (measured by the SF-12 questionnaire), sleep disturbance (measured by the Medical Outcomes Study Sleep Scale), and percentage of patients with neuropathic pain (measured by the Douleur Neuropathique in 4 Questions).
Discussion
Gabapentin is an anticonvulsant type of analgesic that could prevent the onset of PHN by its antihypersensitivity action in dorsal horn neurons.
Trial registration
ISRCTN Registry identifier:
ISRCTN79871784
. Registered on 2 May 2013.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
/ Acyclovir - analogs & derivatives
/ Age
/ Analgesics - adverse effects
/ Analgesics - therapeutic use
/ Antiviral Agents - adverse effects
/ Antiviral Agents - therapeutic use
/ Cyclohexanecarboxylic Acids - adverse effects
/ Cyclohexanecarboxylic Acids - therapeutic use
/ Female
/ gamma-Aminobutyric Acid - adverse effects
/ gamma-Aminobutyric Acid - therapeutic use
/ Herpes Zoster - drug therapy
/ Humans
/ Male
/ Medicine
/ Neuralgia, Postherpetic - diagnosis
/ Neuralgia, Postherpetic - physiopathology
/ Neuralgia, Postherpetic - prevention & control
/ Neuralgia, Postherpetic - virology
/ Pain
/ Patients
/ Sleep
/ Spain
/ Statistics for Life Sciences
