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Intravenous Lidocaine for Fibromyalgia

NCT ID: NCT00986505

Last Updated: 2009-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2007-12-31

Brief Summary

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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

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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).

Conditions

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Fibromyalgia

Keywords

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lidocaine fibromyalgia intravenous lidocaine manifestations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine

Comparison between intravenous lidocaine and saline infusion

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Intravenous lidocaine once a week

Interventions

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Lidocaine

Intravenous lidocaine once a week

Intervention Type DRUG

Other Intervention Names

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Lidocaine infusion Saline infusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Federal University of São Paulo

Principal Investigators

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Rioko K Sakata, MD, PhD

Role: STUDY_DIRECTOR

Universidade Federal de São Paulo

Other Identifiers

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IV lidocaine

Identifier Type: -

Identifier Source: org_study_id