Intravenous Lidocaine for Fibromyalgia
|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 ]
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|