Intravenous Lidocaine for Fibromyalgia
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Drug: Lidocaine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia |
- pain [ Time Frame: 1day ] [ Designated as safety issue: No ]
- other signs [ Time Frame: 1day ] [ Designated as safety issue: No ]
| Enrollment: | 30 |
| Study Start Date: | February 2005 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lidocaine
Comparison between intravenous lidocaine and saline infusion
|
Drug: Lidocaine
Intravenous lidocaine once a week
Other Names:
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Thyroid, rheumatological, renal and hepatic function
- Trauma
- Rheumatic, neuromuscular or psychiatric disease
- Infectious arthropathy
- Other pain syndromes
- Drug hypersensitivity; AND
- Pregnancy
Contacts and Locations More Information
No publications provided
| Responsible Party: | Roberto Vlainich, Federal University of São Paulo |
| ClinicalTrials.gov Identifier: | NCT00986505 History of Changes |
| Other Study ID Numbers: | IV lidocaine |
| Study First Received: | August 3, 2009 |
| Last Updated: | September 29, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
lidocaine fibromyalgia intravenous lidocaine manifestations |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Lidocaine Anesthetics, Local Anesthetics |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013