Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. The disease is characterized by thickening and fibrosis skin, affecting vessels and many organs such as the esophagus, stomach, bowls, lung, heart and kidney. The exact cause or causes of scleroderma are still unknown, but scientists and medical investigators in a wide variety of fields are working hard to make those determinations. It is known that scleroderma involves overproduction of collagen. FLICKMAN et al, in 1973 published an article about the role of lidocaine at prolyl-hydroxylase activity decrease, which is an important enzyme of collagen production. Until now, there is only a case series showing the improvement of thickening skin (75%) and esophagus symptoms (66%) after intravenous lidocaine 2% during 10 days. So it is necessary a RCT to prove these findings.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
* first 5 days: 20ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours * next 5 days: 30ml lidocaine 2% without vessel constrictor + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
first 5 days: 20ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours next 5 days: 30ml of physiological solution 0,9% 500ml + physiological solution 0,9% 500ml intravenously during 4 hours total: 10 days
Universidade Federal de São Paulo
São Paulo, São Paulo, Brazil
Skin thickening evaluated by Skin Score
Time frame: before, immediately after the intervention and 6 months later
Safety - evaluated by the adverse effects during the intervention
Time frame: immediately after the intervention
Quality of Life evaluated by HAQ
Time frame: before, immediately after the intervention and 6 months later
Pressure at lower esophagus evaluated by esophagus manometry
Time frame: before, immediately after the intervention and 6 months later
Vessel alterations (as the number deletion/ectasia) evaluated by fingernail capillaroscopy
Time frame: before, immediately after the intervention and 6 months later
Subjective evaluation by patients
Time frame: before, immediately after the intervention and 6 months later
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