Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy

NCT ID: NCT06551779

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-09
• Study Completion Date: 2024-05-31

Brief 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.

Detailed Description

This study aims to evaluate the efficacy of dextrose perineural injection therapy while motivating and serving as a foundation for future studies to compare or create alternatives and therapeutic methods tailored to the needs patients, with the goal of improving functionality and aesthetics.

Conditions

Bell´s Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Grupo experimental:

Experimental Group: Patients who meet the inclusion and exclusion criteria, to whom perineural injection with dextrose and conventional physical therapy will be applied for the treatment of Bell's palsy.

Group Type: EXPERIMENTAL

inyección perineural con solución de dextrosa tamponada

Intervention Type: PROCEDURE

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.

Control:

Control Group: Patients who meet the inclusion and exclusion criteria, to whom only conventional physical therapy will be applied for Bell's palsy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age 18 years and older.
• Both male and female.
• Duration of symptoms longer than 6 days.
• Apparently healthy, without any associated comorbidities such as diabetes mellitus, obesity, hypothyroidism, hyperthyroidism, metabolic syndrome, or any neurological disorder.
• Grade III (moderate dysfunction), IV (moderate to severe dysfunction), V (severe dysfunction), or VI (total paralysis) according to the House-Brackmann Classification.
• Exclusive attention from UMF 2, 3, 4, 6, 11, 16, 29, 34, 35, 42, 94, 120 and the Physical Medicine and Rehabilitation Unit in the central region (employers and beneficiaries).
• Exclusive attention from the UMF belonging to Mexico City (beneficiaries only).
• Patients willing to participate in the study confirmed with signed informed consent.

Exclusion Criteria

• Active smokers.
• Patients with central facial paralysis.
• Patients with peripheral facial paralysis secondary to tumors or surgical treatment.
• Patients experiencing more than second episode of Peripheral Facial Paralysis.
• Patients with cognitive and/or mental impairments.
• Patients undergoing additional private therapy.
• Patients with bilateral facial paralysis.
• Pregnant patients.
• Patients unwilling to participate in the study.
• Patients who have received prior rehabilitation, laser, electrotherapy, or acupuncture.
• Elimination Criteria:

• Patients who do not attend rehabilitation sessions.
• Patients diagnosed with Sars-cov2 infection during the study.
• Patients who discontinue treatment.
• Patients developing other pathologies requiring special treatment.
• Patients wishing to withdraw from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARIANA GUADALUPE MARTINEZ SILVA

UNKNOWN

Sponsor Role: collaborator

MARIA DE LOS ANGELES HERNANDEZ SANCHEZ

UNKNOWN

Sponsor Role: collaborator

MERCEDES DE JESUS JUAREZ LOPEZ

UNKNOWN

Sponsor Role: collaborator

IVAN HUERTA GRANADA

UNKNOWN

Sponsor Role: collaborator

MARIA CATALINA SANTIAGO SANTIAGO

UNKNOWN

Sponsor Role: collaborator

VICTOR MANUEL CAMARILLO NAVA

UNKNOWN

Sponsor Role: collaborator

Celia Itxelt Infante Castro

OTHER_GOV

Sponsor Role: lead

Responsible Party

Celia Itxelt Infante Castro

Clinical Coordination of Health Education and Research.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

MARIA DE LOS ANGELES HERNANDEZ SANCHEZ, DRA

Role: PRINCIPAL_INVESTIGATOR

MEDICA ADSCRITA A UNIDAD DE MEDICINA FISICA Y REHABILITACION REGION CENTRO IMSS

Locations

Unidad de Medicina Física Y Rehabilitacion Region Centro Imss

Mexico City, Cuauhtemoc, Mexico

Countries

Mexico

Other Identifiers

R-2024-1501-001

Identifier Type: -

Identifier Source: org_study_id