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NCT Number: NCT06551779

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

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.

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Key information

Conditions

Bell´s Palsy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unidad de Medicina Física Y Rehabilitacion Region Centro Imss

Mexico City, Cuauhtemoc, 06500, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria: Patients with Bell's Palsy who:
  • 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.

Treatment and study plan

inyección perineural con solución de dextrosa tamponada

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.

Primary outcomes

  1. Efficacy in functionality

    Time frame: ≥8 weeks

    A= Functionality facial B= Recovery in time

  2. Recovery in time

    Time frame: 1= ≥8 weeks 2= ≤ 8 weeks

    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.

  3. Functionality facial

    Time frame: ≥8 Weeks or ≤ 8 weeks

    • Manual examination of facial muscles. It is a clinical evaluation to determine the function and strength of a person's facial muscles.
    • 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).
    • 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.

Sponsors and collaborators

Lead sponsor

Celia Itxelt Infante Castro

Other Gov

Collaborators

  • ARIANA GUADALUPE MARTINEZ SILVA
  • IVAN HUERTA GRANADA
  • MARIA CATALINA SANTIAGO SANTIAGO
  • MARIA DE LOS ANGELES HERNANDEZ SANCHEZ
  • MERCEDES DE JESUS JUAREZ LOPEZ
  • VICTOR MANUEL CAMARILLO NAVA

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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