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Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)

Primary Purpose

Fibromyalgia, Chronic Pain

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Lidocaine;, Fibromyalgia, signs, symptoms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of São Paulo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lidocaine

Arm Description

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).

Outcomes

Primary Outcome Measures

effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia

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

Full Information

First Posted
October 6, 2009
Last Updated
October 8, 2009
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00991848
Brief Title
Lidocaine on Manifestations of Fibromyalgia
Acronym
LIMAFIBRO
Official Title
Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain
Keywords
Lidocaine;, Fibromyalgia, signs, symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
received 240 mg lidocaine diluted in 125 mL 0.9% saline.
Primary Outcome Measure Information:
Title
effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rioko K Sakata, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Federal University of São Paulo
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

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Lidocaine on Manifestations of Fibromyalgia

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