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Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)

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ClinicalTrials.gov Identifier: NCT00991848
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : October 9, 2009
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Drug: Lidocaine Phase 1

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Study Start Date : January 2005
Primary Completion Date : July 2007
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).
Drug: Lidocaine
received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Outcome Measures

Primary Outcome Measures :
  1. effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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

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
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): NCT00991848

Federal University of São Paulo
São Paulo, Brazil
Sponsors and Collaborators
Federal University of São Paulo
Study Chair: Rioko K Sakata, PhD Federal University of São Paulo
More Information

Responsible Party: Roberto Vlainich, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00991848     History of Changes
Other Study ID Numbers: MAF09
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 2009

Keywords provided by Federal University of São Paulo:

Additional relevant MeSH terms:
Chronic Pain
Myofascial Pain Syndromes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Anesthetics, Local
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