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Intravenous Lidocaine for Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00986505
First Posted: September 30, 2009
Last Update Posted: September 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Federal University of São Paulo
  Purpose
The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.

Condition Intervention
Fibromyalgia Drug: Lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • pain [ Time Frame: 1day ]

Secondary Outcome Measures:
  • other signs [ Time Frame: 1day ]

Enrollment: 30
Study Start Date: February 2005
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Comparison between intravenous lidocaine and saline infusion
Drug: Lidocaine
Intravenous lidocaine once a week
Other Names:
  • Lidocaine infusion
  • Saline infusion

Detailed Description:

Thirty patients ranging in age from 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points) were studied. Other manifestations were also recorded: sleep disorders, fatigue, subjective edema, depression, and paresthesia.

Criteria for exclusion were alterations in thyroid, rheumatological, renal and hepatic function; trauma; rheumatic, neuromuscular or psychiatric disease; infectious arthropathy; other pain syndromes; drug hypersensitivity, and pregnancy.

All patients received amitriptyline at a dose of 12.5 mg in the first week and 25 mg over the subsequent 4 weeks. Patients of group 1 (n = 15) received 125 mL 0.9% saline and patients of group 2 (n = 15) received 240 mg lidocaine diluted in 125 mL 0.9% saline. The solutions were infused over a period of 1 h, once a week, for 4 weeks (T1, T2, T3 and T4).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points

Exclusion Criteria:

  • Thyroid, rheumatological, renal and hepatic function
  • Trauma
  • Rheumatic, neuromuscular or psychiatric disease
  • Infectious arthropathy
  • Other pain syndromes
  • Drug hypersensitivity; AND
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986505


Sponsors and Collaborators
Federal University of São Paulo
Investigators
Study Director: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
  More Information

Responsible Party: Roberto Vlainich, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00986505     History of Changes
Other Study ID Numbers: IV lidocaine
First Submitted: August 3, 2009
First Posted: September 30, 2009
Last Update Posted: September 30, 2009
Last Verified: September 2009

Keywords provided by Federal University of São Paulo:
lidocaine
fibromyalgia
intravenous lidocaine
manifestations

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action