Amitriptyline in the treatment of neuropathic pain in patients affected by Hansens desease: a randomized controlled trial

• Grant number: 19/20951-6
• Support Opportunities: Regular Research Grants
• Start date: June 01, 2020
• End date: May 31, 2022
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Daniel Ciampi Araujo de Andrade
• Grantee: Daniel Ciampi Araujo de Andrade
• Host Institution: Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Antonia Lilian de Lima Rodrigues ; Dejair Caitano do Nascimento ; Manoel Jacobsen Teixeira ; Ricardo Galhardoni ; Valquíria Aparecida da Silva

Abstract

Hansen's disease (Hansen's disease-MH) is an infectious-contagious disease caused by Mycobacterium leprae that has the man as the main host. MH, despite having its incidence in decline, is still an important cause of morbidity in some countries of the world, with Brazil being one of the main. Thus, 60% of the world's cases are concentrated in two countries: India and Brazil. Although it is known as a pathology with reduced sensitivity, in recent years, with a more complete follow-up of patients with leprosy diagnosis, it has been observed that pain affects a large portion of the patients at least at some point in the disease (Stump et al., 2004). We propose in this study the use of tramadol for all patients and we will add amitriptyline to one of the groups, thus analyzing whether amitriptyline will add analgesic effect to patients who are already being treated for DNe. In this way we will be assured that no patient will be left untreated for pain and placebo control will tell us how much analgesic effect amitriptyline will add. Objectives: To assess the efficacy of flexible dose amitriptyline in patients with placebo-controlled leprosy-related neuropathic pain in patients receiving treatment for tramadol neuropathic pain through the number of responders (30% reduction in pain intensity to baseline) between the two groups.This is a prospective, interventional, multicenter, parallel-group, randomized, double-blind placebo controlled study. The follow-up of each patient will last a total of nine weeks. The study will have data collection extending for 24 months. Because it is a multicenter study, the study population will be composed of patients with neuromuscular pain recruited at the Hospital das Clinicas of the Medical School of the University of São Paulo, in two outpatient clinics: Neurology and Dermatology. Patients will also be recruited at the Lauro Souza Lima Institute, a reference center for leprosy treatment in the city of Bauru - SP. (AU)