Lidocaine on Manifestations of Fibromyalgia (LIMAFIBRO)
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|ClinicalTrials.gov Identifier: NCT00991848|
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : October 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Chronic Pain||Drug: Lidocaine||Phase 1|
Amitriptyline was chosen in the present study because it is the most widely used antidepressant with proven analgesic efficacy for the treatment of a variety of chronic pain syndromes. Amitriptyline also promotes improvement of sleep, an effect observed in the present study.
Lidocaine has been widely applied by the intravenous route and patients with a variety of pain syndromes, including fibromyalgia, have reported pain relief with this technique.The dose of lidocaine employed by various investigators ranges from 1 to 5 mg/kg administered over a period of 30-60 min. The minimum effective dose is 1.5 mL/L, which is achieved with 2-5 mg/kg infused over 30-60 min. In these study, 240 mg lidocaine was administered, corresponding to about 3 mg/kg.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||September 2008|
Patients 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).
received 240 mg lidocaine diluted in 125 mL 0.9% saline.
- effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia [ Time Frame: 4 weeks ]
- Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity [ Time Frame: 4 weeks ]
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): NCT00991848
|Federal University of São Paulo|
|São Paulo, Brazil|
|Study Chair:||Rioko K Sakata, PhD||Federal University of São Paulo|