Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy
NCT06551779 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2024-08-13
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.
Conditions
- Bell´s Palsy
Interventions
- PROCEDURE
-
inyección perineural con solución de dextrosa tamponada
Application of perineural injection with buffered dextrose solution, adding 2.5 ml of 7.5% sodium bicarbonate to a 250 ml bottle of glucose solution at 5% concentration, applying 1cc of the solution at different points on the path of the facial nerve.
Sponsors & Collaborators
-
ARIANA GUADALUPE MARTINEZ SILVA
collaborator UNKNOWN -
MARIA DE LOS ANGELES HERNANDEZ SANCHEZ
collaborator UNKNOWN -
MERCEDES DE JESUS JUAREZ LOPEZ
collaborator UNKNOWN -
IVAN HUERTA GRANADA
collaborator UNKNOWN -
MARIA CATALINA SANTIAGO SANTIAGO
collaborator UNKNOWN -
VICTOR MANUEL CAMARILLO NAVA
collaborator UNKNOWN -
Celia Itxelt Infante Castro
lead OTHER_GOV
Principal Investigators
-
MARIA DE LOS ANGELES HERNANDEZ SANCHEZ, DRA · MEDICA ADSCRITA A UNIDAD DE MEDICINA FISICA Y REHABILITACION REGION CENTRO IMSS
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-02-09
- Primary Completion
- 2024-05-15
- Completion
- 2024-05-31
Countries
- Mexico
Study Locations
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