Trials / Completed
CompletedNCT06551779
Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Celia Itxelt Infante Castro · Other Government
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-02-09
- Primary completion
- 2024-05-15
- Completion
- 2024-05-31
- First posted
- 2024-08-13
- Last updated
- 2024-08-13
Locations
1 site across 1 country: Mexico
Source: ClinicalTrials.gov record NCT06551779. Inclusion in this directory is not an endorsement.