Bell´s PalsyNCT06551779
Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy
A study testing inyección perineural con solución de dextrosa tamponada in people with Bell´s Palsy, run by Celia Itxelt Infante Castro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bell´s Palsy
- What is being tested?
- inyección perineural con solución de dextrosa tamponada
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteMexico
- Study dates
- 9 Feb 2024to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Medicina Física Y Rehabilitacion Region Centro Imss
Mexico City, Cuauhtemoc, 06500
About this study
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.
Read the 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
- Being tested
- inyección perineural con solución de dextrosa tamponada
- Keywords
- perineural injection therapy, dextrose, bell´s palsy, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inyección perineural con solución de dextrosa tamponadaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Grupo experimental: | 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. Receives: Procedure: inyección perineural con solución de dextrosa tamponada |
| Control: | No intervention | Control Group: Patients who meet the inclusion and exclusion criteria, to whom only conventional physical therapy will be applied for Bell's palsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in functionality
A= Functionality facial B= Recovery in time
Measured: ≥8 weeks
Recovery in time
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.
Measured: 1= ≥8 weeks 2= ≤ 8 weeks
Functionality facial
- 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.
Measured: ≥8 Weeks or ≤ 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start9 Feb 2024
- Primary completion15 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell´s PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. Control Group: Patients who meet the inclusion and exclusion criteria, to whom only conventional physical therapy will be applied for Bell's palsy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celia Itxelt Infante Castro
- Sponsor type
- Other government
- Collaborators
- ARIANA GUADALUPE MARTINEZ SILVA, MARIA DE LOS ANGELES HERNANDEZ SANCHEZ, MERCEDES DE JESUS JUAREZ LOPEZ, IVAN HUERTA GRANADA, MARIA CATALINA SANTIAGO SANTIAGO, VICTOR MANUEL CAMARILLO NAVA
- Responsible party
- Sponsor-investigator, Celia Itxelt Infante Castro, Instituto Mexicano del Seguro Social
- Investigators
- MARIA DE LOS ANGELES HERNANDEZ SANCHEZ, DRA, Principal investigator, MEDICA ADSCRITA A UNIDAD DE MEDICINA FISICA Y REHABILITACION REGION CENTRO IMSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06551779
- Sponsor's protocol ID
- R-2024-1501-001
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Perineural Injection With Dextrose Versus Therapy Conventional Physics in Patients With Bell's Palsy
- ClinicalTrials.gov ID
- NCT06551779
- Acronym / sponsor ID
- R-2024-1501-001
- Conditions
- Bell´s Palsy
- Keywords
- perineural injection therapy, dextrose, bell´s palsy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Celia Itxelt Infante CastroOther government
- Collaborators
- ARIANA GUADALUPE MARTINEZ SILVA, MARIA DE LOS ANGELES HERNANDEZ SANCHEZ, MERCEDES DE JESUS JUAREZ LOPEZ, IVAN HUERTA GRANADA, MARIA CATALINA SANTIAGO SANTIAGO, VICTOR MANUEL CAMARILLO NAVA
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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. Control Group: Patients who meet the inclusion and exclusion criteria, to whom only conventional physical therapy will be applied for Bell's palsy.
| Arm | Type | Receives |
|---|---|---|
| Grupo experimental: | Experimental | Procedure: inyección perineural con solución de dextrosa tamponadaExperimental 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. |
| Control: | No intervention | –Control Group: Patients who meet the inclusion and exclusion criteria, to whom only conventional physical therapy will be applied for Bell's palsy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (16 listed)
- Elimination Criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inyección perineural con solución de dextrosa tamponadaApplication 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. | Procedure or surgery | Grupo experimental: |
Primary outcome
Efficacy in functionality
Time frame: ≥8 weeks
A= Functionality facial B= Recovery in time
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.
Functionality facial
Time frame: ≥8 Weeks or ≤ 8 weeks
1. Manual examination of facial muscles. It is a clinical evaluation to determine the function and strength of a person's facial muscles. 2. 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). 3. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Bell´s Palsy
Enrolling by invitation
EXPLORING EFFECTIVENESS OF LOW LEVEL LASER THERAPY IN THE TREATMENT OF PATIENTS WITH BELLS PALSY
Bell Palsy, Bell's Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARIA DE LOS ANGELES HERNANDEZ SANCHEZ, DRA principal investigator
MEDICA ADSCRITA A UNIDAD DE MEDICINA FISICA Y REHABILITACION REGION CENTRO IMSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inyección perineural con solución de dextrosa tamponada in people with Bell´s Palsy, run by Celia Itxelt Infante Castro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in functionality (time frame: ≥8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.