Chronic Pain Clinical Trial
— LIMAFIBROOfficial title:
Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
Verified date | October 2009 |
Source | Federal University of São Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | September 2008 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Federal University of São Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Federal University of São Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia | 4 weeks | Yes | |
Secondary | Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity | 4 weeks | Yes |
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