Neuritis
Conditions
Interventions
Intervention group: 58 people will receive 1 mg / kg weight / day of oral corticosteroids with a weekly reduction of 10 mg for a period of 6 months and 1 tablet of 25 mg / day of amitriptyline for 6 m
Control group: 58 people will receive oral corticosteroids with a weekly reduction of 10 mg for a period of 6 months and 1 placebo tablet for 6 months.
Drug
Sponsors
Fundação Oswaldo Cruz
Instituto Oswaldo Cruz
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: Result of clinical evaluation (signs / symptoms compatible with neural pain) and the DN4 questionnaire when applied; To evaluate the relationship between the impairment of pain inhibitory pathway measured by Thermal Sensitivity Analysis (TQS) and the result of DN prophylaxis.;Expected outcome 3: Assess the association between neuritis and neuropathic pain findings, assessed by USG, the therapeutic response to amitriptyline; Evaluate the morphology of the affected nerve (s) by ultrasound imaging (USG);;Expected outcome 4: Check whether patients with elevated serum cytokines have a worse response to treatment with amitriptyline; Analyze the inflammatory response in patients with neuritis in order to prove that the cases identified as more susceptible to neuritis due to elevated TNF alpha and neuropathic pain due to increased IL-1? and IL-17 did not present this complication with the use of amitriptyline;;Expected outcome 5: Assess the presence of adverse events associated with the concomitant use of amitriptyline and corticosteroids;;Expected outcome 6: Clinical complications, such as drowsiness and dryness of the mouth. | — |
Countries
Brazil
Contacts
Public ContactMilton de Moraes
Fundação Oswaldo Cruz
Outcome results
None listed