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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06551779 on ClinicalTrials.gov