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
  Purpose

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 Intervention Phase
Fibromyalgia
Chronic Pain
Drug: Lidocaine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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:
  • effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: January 2005
Study Completion Date: September 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991848

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

No publications provided

Responsible Party: Roberto Vlainich, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00991848     History of Changes
Other Study ID Numbers: MAF09, NSA
Study First Received: October 6, 2009
Last Updated: October 8, 2009
Health Authority: Brazil: Ministry of Health

Keywords provided by Federal University of São Paulo:
Lidocaine;
Fibromyalgia
signs
symptoms

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014