Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT00986505
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).
Study:
NCT00986505
Study Brief:
Protocol Section:
NCT00986505