Lidocaine on Manifestations of Fibromyalgia

NCT ID: NCT00991848

Last Updated: 2009-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2008-09-30

Brief Summary

Background and Objectives: Fibromyalgia is a pain syndrome characterized by numerous manifestations. The objective of this study was to evaluate the effect of the combination of intravenous lidocaine and amitriptyline on the manifestations of fibromyalgia. Methods: A prospective, randomized, double-blind, comparative study was conducted. All patient received 25 mg amitriptyline. Patients of group 1 (n = 15) received 125 mL 0.9% saline, and patients of group 2 (n = 15) received 240 mg lidocaine in 125 mL 0.9% saline once a week for 4 weeks. Manifestations were recorded before and 4 weeks after treatment. Pain intensity was rated on a verbal numerical scale.

Detailed Description

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.

Conditions

Fibromyalgia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine

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).

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Interventions

Lidocaine

received 240 mg lidocaine diluted in 125 mL 0.9% saline.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• pain in the four quadrants of the body for at least 3 months
• sleep disorders
• fatigue
• subjective edema
• depression
• paresthesia.

Exclusion Criteria

• alterations in thyroid
• rheumatological
• renal and hepatic function
• trauma
• rheumatic, neuromuscular or psychiatric disease
• infectious arthropathy
• other pain syndromes
• drug hypersensitivity
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of São Paulo

Principal Investigators

Rioko K Sakata, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NSA

Identifier Type: -

Identifier Source: secondary_id

MAF09

Identifier Type: -

Identifier Source: org_study_id