Efficacy of gabapentin for prevention of postherpetic neuralgia: study protocol for a randomized controlled clinical trial

Autor: Rullan, Manuel, Bulilete, Oana, Leiva, Alfonso, Soler Mieras, Aina, Roca, Antonia, Jose Gonzalez-Bals, Maria, Lorente, Patricia, Llobera Cànaves, Joan, PHN Grp
Jazyk: angličtina
Předmět:
Male
sueño
Time Factors
antivíricos
Cyclohexanecarboxylic Acids
humanos
Herpes zoster
Acyclovir
Neuralgia
Postherpetic
Medicine (miscellaneous)
neuralgia
Study Protocol
0302 clinical medicine
Clinical Protocols
analgésicos
ácido gamma-aminobutírico
Surveys and Questionnaires
valina
Pharmacology (medical)
030212 general & internal medicine
Amines
mediana edad
gamma-Aminobutyric Acid
Primary health care
Pain Measurement
Analgesics
Dysesthesia
resultado del tratamiento
Valine
ácidos ciclohexanocarboxílicos
Middle Aged
Allodynia
medida del dolor
Treatment Outcome
Research Design
Anesthesia
Valacyclovir
Hyperalgesia
Neuropathic pain
Postherpetic neuralgia
Female
medicine.symptom
Gabapentin
medicine.drug
aminas
Visual analogue scale
Analgesic
Antiviral Agents
03 medical and health sciences
factores de tiempo
Double-Blind Method
medicine
Humans
método con doble ocultación
protocolos clínicos
business.industry
Prevention
medicine.disease
aciclovir
Spain
calidad de vida
Quality of Life
business
Sleep
030217 neurology & neurosurgery
diseño de la investigación
Zdroj: Trials
ISSN: 1745-6215
DOI: 10.1186/s13063-016-1729-y
Popis: 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.
This study was funded by the Ministry of Health, Carlos III Institute (grant PI12/01813). We also received support from the Health Promotion and Preventive Activities-Primary Health Care Network, sustained by the Ministry of Health, Carlos III Institute, Redes Tematicas de Investigacion Cooperativa en Salud (RETIC) award RD12/0005/0011, co-financed by the European Union European Regional Development Fund. The funders had no role in the study design, data collection, analysis, decision to publish, or preparation of the manuscript.
Databáze: OpenAIRE
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