Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)

October 8, 2009 updated by: Federal University of São Paulo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Study Chair: Rioko K Sakata, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

October 6, 2009

First Submitted That Met QC Criteria

October 7, 2009

First Posted (ESTIMATE)

October 8, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 9, 2009

Last Update Submitted That Met QC Criteria

October 8, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF09
  • NSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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