Intravenous Lidocaine for Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT00986505|
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : September 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Lidocaine||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||December 2007|
Comparison between intravenous lidocaine and saline infusion
Intravenous lidocaine once a week
- pain [ Time Frame: 1day ]
- other signs [ Time Frame: 1day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986505
|Study Director:||Rioko K Sakata, MD, PhD||Universidade Federal de São Paulo|