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临床试验/NCT00986505
NCT00986505已完成不适用

Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia

Federal University of São Paulo0 个研究点目标入组 30 人开始时间: 2005年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
pain

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Thyroid, rheumatological, renal and hepatic function
  • Rheumatic, neuromuscular or psychiatric disease
  • Infectious arthropathy
  • Other pain syndromes
  • Drug hypersensitivity; AND
  • Pregnancy

研究组 & 干预措施

Lidocaine

Experimental

Comparison between intravenous lidocaine and saline infusion

干预措施: Lidocaine (Drug)

结局指标

主要结局

pain

时间窗: 1day

次要结局

  • other signs(1day)

研究者

发起方
Federal University of São Paulo
申办方类型
Other

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