Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00991848
First received: October 6, 2009
Last updated: October 8, 2009
Last verified: October 2009

October 6, 2009
October 8, 2009
January 2005
July 2007   (final data collection date for primary outcome measure)
effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00991848 on ClinicalTrials.gov Archive Site
Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Lidocaine on Manifestations of Fibromyalgia
Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

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.

Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study.

Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Fibromyalgia
  • Chronic Pain
Drug: Lidocaine
received 240 mg lidocaine diluted in 125 mL 0.9% saline.
Experimental: Lidocaine
Patients 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).
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
September 2008
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00991848
MAF09, NSA
Yes
Roberto Vlainich, Federal University of São Paulo
Federal University of São Paulo
Not Provided
Study Chair: Rioko K Sakata, PhD Federal University of São Paulo
Federal University of São Paulo
October 2009

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