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Lidocaine on Manifestations of Fibromyalgia

CompletedPhase 1NCT00991848
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Interventions
Sponsor
Federal University of São Paulo
Start date
2005-01
Primary completion
2007-07
Sex
All
Age range
from 18 Years to 60 Years
Results posted
No results posted in this snapshot
Countries
Brazil
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * pain in the four quadrants of the body for at least 3 months * sleep disorders * fatigue * subjective edema * depression * paresthesia. Exclusion Criteria: * alterations in thyroid * rheumatological * renal and hepatic function * trauma * rheumatic, neuromuscular or psychiatric disease * infectious arthropathy * other pain syndromes * drug hypersensitivity * pregnancy

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00991848