drugset / Trial / NCT00991848

Lidocaine on Manifestations of Fibromyalgia

NCT00991848

Phase 1 Completed 30 enrolled Federal University of São Paulo
RandomizedParallel-groupDouble-blindTreatment

Summary

Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.

Timeline

Start
2005-01
Primary completion
2007-07
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 240 mg Intravenous

Indications