Lidocaine on Manifestations of Fibromyalgia
LIMAFIBRO
Effect of Intravenous Lidocaine on Manifestations of Fibromyalgia
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 8, 2009
CompletedOctober 9, 2009
October 1, 2009
2.5 years
October 6, 2009
October 8, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
effect of the combination of intravenous lidocaine and amitriptyline on the clinical manifestations of fibromyalgia
4 weeks
Secondary Outcomes (1)
Pain intensity by numerical scale (0 - 10)where 0 being an absent of pain and 10 measuring as the highest for pain intensity
4 weeks
Study Arms (1)
Lidocaine
EXPERIMENTALPatients 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).
Interventions
Eligibility Criteria
You may qualify if:
- pain in the four quadrants of the body for at least 3 months
- sleep disorders
- fatigue
- subjective edema
- depression
- paresthesia.
You may not qualify if:
- alterations in thyroid
- rheumatological
- renal and hepatic function
- trauma
- rheumatic, neuromuscular or psychiatric disease
- infectious arthropathy
- other pain syndromes
- drug hypersensitivity
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of São Paulo
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Rioko K Sakata, PhD
Federal University of São Paulo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 8, 2009
Study Start
January 1, 2005
Primary Completion
July 1, 2007
Study Completion
September 1, 2008
Last Updated
October 9, 2009
Record last verified: 2009-10