Intravenous Lidocaine for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring lidocaine, fibromyalgia, intravenous lidocaine, manifestations
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
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
NCT ID
NCT00986505
First Posted
August 3, 2009
Last Updated
September 29, 2009
Sponsor
Federal University of São Paulo
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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