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

August 3, 2009
September 29, 2009
February 2005
October 2007   (final data collection date for primary outcome measure)
pain [ Time Frame: 1day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00986505 on ClinicalTrials.gov Archive Site
other signs [ Time Frame: 1day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intravenous Lidocaine for Fibromyalgia
Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
Drug: Lidocaine
Intravenous lidocaine once a week
Other Names:
  • Lidocaine infusion
  • Saline infusion
Experimental: Lidocaine
Comparison between intravenous lidocaine and saline infusion
Intervention: Drug: Lidocaine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00986505
IV lidocaine
No
Roberto Vlainich, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Study Director: Rioko K Sakata, MD, PhD Universidade Federal de São Paulo
Federal University of São Paulo
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP