Intravenous Lidocaine for Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00986505
First received: August 3, 2009
Last updated: September 29, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • other signs [ Time Frame: 1day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00986505

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

No publications provided

Responsible Party: Roberto Vlainich, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00986505     History of Changes
Other Study ID Numbers: IV lidocaine
Study First Received: August 3, 2009
Last Updated: September 29, 2009
Health Authority: Brazil: National Committee of Ethics in Research

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014