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Intravenous Lidocaine for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
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, intravenous lidocaine, manifestations

Eligibility Criteria

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

Inclusion Criteria:

  • 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points

Exclusion Criteria:

  • Thyroid, rheumatological, renal and hepatic function
  • Trauma
  • Rheumatic, neuromuscular or psychiatric disease
  • Infectious arthropathy
  • Other pain syndromes
  • Drug hypersensitivity; AND
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Lidocaine

    Arm Description

    Comparison between intravenous lidocaine and saline infusion

    Outcomes

    Primary Outcome Measures

    pain

    Secondary Outcome Measures

    other signs

    Full Information

    First Posted
    August 3, 2009
    Last Updated
    September 29, 2009
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00986505
    Brief Title
    Intravenous Lidocaine for Fibromyalgia
    Official Title
    Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
    Study Type
    Interventional

    2. Study Status

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

    3. Sponsor/Collaborators

    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The effect of intravenous lidocaine infusion on manifestations of fibromyalgia manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a numerical scale.The combination of 240 mg intravenous lidocaine (once a week) and 25 mg amitriptyline for 4 weeks did not modify pain intensity or manifestations in patients with fibromyalgia.
    Detailed Description
    Thirty patients ranging in age from 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points) were studied. Other manifestations were also recorded: sleep disorders, fatigue, subjective edema, depression, and paresthesia. Criteria for exclusion were alterations in thyroid, rheumatological, renal and hepatic function; trauma; rheumatic, neuromuscular or psychiatric disease; infectious arthropathy; other pain syndromes; drug hypersensitivity, and pregnancy. All patients received amitriptyline at a dose of 12.5 mg in the first week and 25 mg over the subsequent 4 weeks. Patients of group 1 (n = 15) received 125 mL 0.9% saline and patients of group 2 (n = 15) 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fibromyalgia
    Keywords
    lidocaine, fibromyalgia, intravenous lidocaine, manifestations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine
    Arm Type
    Experimental
    Arm Description
    Comparison between intravenous lidocaine and saline infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Other Intervention Name(s)
    Lidocaine infusion, Saline infusion
    Intervention Description
    Intravenous lidocaine once a week
    Primary Outcome Measure Information:
    Title
    pain
    Time Frame
    1day
    Secondary Outcome Measure Information:
    Title
    other signs
    Time Frame
    1day

    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: 18 to 60 years, with fibromyalgia (American College of Rheumatology criteria: pain in the four quadrants of the body for at least 3 months and a minimum of 11 out of 18 tender points Exclusion Criteria: Thyroid, rheumatological, renal and hepatic function Trauma Rheumatic, neuromuscular or psychiatric disease Infectious arthropathy Other pain syndromes Drug hypersensitivity; AND Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rioko K Sakata, MD, PhD
    Organizational Affiliation
    Universidade Federal de São Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Intravenous Lidocaine for Fibromyalgia

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