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Lidocaine on Manifestations of Fibromyalgia

NCT00991848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-10-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lidocaine

received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Rioko K Sakata, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-07-31
Completion
2008-09-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00991848 on ClinicalTrials.gov