Randomized trial using amitriptyline medication to prevent neuropathic pain in patients who have leprosy neuritis.

Phase 2

• Conditions: euritis; R52.1; C10.668.829.500.500; leprosy; C01.252.410.040.552.386; Intractable chronic pain; Median neuropathy; C10.668.829.650

• Registration Number: RBR-5539cm
• Lead Sponsor: Fundação Oswaldo Cruz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

The study will include patients older than 18 years; with a clinical diagnosis of neuritis; confirmed by electroneuromyography; registered at the service and diagnosed with neuritis; from February 2020 to January 2022.

Exclusion Criteria

Patients diagnosed with neuropathic pain;Patients with known contraindications to the use of amitriptyline: ischemic heart,disease, cardiac arrhythmia, glaucoma and / or history of urinary retention in men;Patients with concomitant leprous nodular; erythema being treated with thalidomide;Patient with previous use ofamitriptyline and or neuropathic pain;Patient with cognitive impairment;Pregnancy or breastfeeding;Prophylactic use of amitriptyline in a previous episode of neuritis, that is, the patient will only be included once

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: Frequency of cases of neuropathic pain among patients with neuritis treated with oral prednisone and amitriptyline for 6 months compared to the group that received oral prednisone and placebo.