Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy
NCT Number: NCT06551779
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bell´s Palsy
Interventions: PROCEDURE: inyección perineural con solución de dextrosa tamponada
Sponsor: Celia Itxelt Infante Castro
Collaborators: ARIANA GUADALUPE MARTINEZ SILVA|MARIA DE LOS ANGELES HERNANDEZ SANCHEZ|MERCEDES DE JESUS JUAREZ LOPEZ|IVAN HUERTA GRANADA|MARIA CATALINA SANTIAGO SANTIAGO|VICTOR MANUEL CAMARILLO NAVA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 21
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-02-09
Completion Date: 2024-05-31
Locations: Unidad de Medicina Física Y Rehabilitacion Region Centro Imss, Ciudad de mexico, Cuauhtemoc, 06500, Mexico

Summary:
Bell´s Palsy, a lower motor neuron injury that causes facial asymmetry due to facial weakness ranging from mild to total paralysis. Most of cases without determining a definitive established cause. The only authenticated findings are inflammation and edema of the facial nerve. In Mexico, it is among the first causes of medical attention. In the Mexican Clinical Practice Guide for Bells Palsy, thermotherapy, massage, and active exercises are recommended for its management. Perineural dextrose injection therapy (PIT) is a new treatment for peripheral neuropathy, which consists of injecting 5% buffered dextrose close to nerve pathways to restore nerve function and movement. Objective: Determine the effectiveness of perineural injection with dextrose versus conventional physical therapy for the treatment of patients with Bell´s palsy. Material and methods: Clinical trial, experimental, prolective, longitudinal, comparative and heterodemic. Resources and infrastructure: It will be carried out within the facilities of the Unidad de Medicina Física y Rehabilitación región centro. In human resources, doctors both specialists and residents in Rehabilitation Medicine and physical therapists. In material resources, stationery, for electroneuromyography study, perineural injection therapy, hand hygiene and disinfection, and for conventional rehabilitation therapy.

Primary Outcome Measures: Efficacy in functionality, A= Functionality facial B= Recovery in time, ≥8 weeks|Recovery in time, It is the action and effect of recovering or recovering (returning to oneself or to a normal state, take back what you had before, compensate) in a set time., 1= ≥8 weeks 2= ≤ 8 weeks|Functionality facial, 1. Manual examination of facial muscles. It is a clinical evaluation to determine the function and strength of a person's facial muscles.
2. Clinical evaluation. The House-Brackmann rating scale used to evaluate facial function and severity of facial paralysis peripheral, which consists of six levels to evaluate six facial expressions starting from normal (grade I) and as the last degree considers total paralysis (grade VI).
3. Assessment electrophysiological with study of electroneurography of facial nerve that consists of the neuro conductions that they involve electrical stimulation of the nerve by measuring its motor response., ≥8 Weeks or ≤ 8 weeks