Bell PalsyPhase 4NCT07728331
Ultrasound-guided Combined Perineural and Intramuscular Dextrose Injection for Management of Refractory Bell's Palsy
A Phase 4 study testing Ultrasound-guided combined perineural and intramuscular dextrose injection. in people with Bell Palsy, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Bell's palsy (BP) is characterized by idiopathic acute weakness of the facial muscles associated with compression of the facial nerve. The present prospective study sought to evaluate the clinical efficacy of ultrasound-guided combined perineural and intramuscular dextrose injection for management of refractory Bell's… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bell Palsy
- What is being tested?
- Ultrasound-guided combined perineural and intramuscular dextrose injection.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 1 Apr 2026
- Phase
- Phase 4
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The study included 30 patients with Bell's palsy diagnosed according to the recommendations of American Academy of Otolaryngology-Head and Neck Surgery Foundation
Who cannot join
- Patients were excluded if they were previously submitted to injection therapy or surgical intervention for management of Bell's palsy. They were also excluded if they had associated mental illness or advanced systemic conditions (e.g. uncontrolled diabetes, uncontrolled hypertension, malignant disease, immunocompromised conditions).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Combined Perineural and Intramuscular Dextrose Injection for Management of Refractory Bell's Palsy A Prospective Study
Bell's palsy (BP) is characterized by idiopathic acute weakness of the facial muscles associated with compression of the facial nerve. The present prospective study sought to evaluate the clinical efficacy of ultrasound-guided combined perineural and intramuscular dextrose injection for management of refractory Bell's palsy. The study included 30 patients with Bell's palsy with House-Brackmann scale ≥ 3 who were refractory to standard medical treatment after 3 months of disease onset. They received ultrasound-guided combined perineural and intramuscular dextrose injection. Clinical outcome was assessed using the House-Brackmann scale.
- Conditions
- Bell Palsy
- Being tested
- Ultrasound-guided combined perineural and intramuscular dextrose injection.
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided combined perineural and intramuscular dextrose injection.Procedure or surgery
Ultrasound-guided combined perineural and intramuscular dextrose injection.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Ultrasound-guided combined perineural and intramuscular dextrose injection. Receives: Procedure: Ultrasound-guided combined perineural and intramuscular dextrose injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
House Brackmann scale
House Brackmann scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start10 Oct 2025
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bell PalsyStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham A. Elazab, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728331
- Sponsor's protocol ID
- 2023031799
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Combined Perineural and Intramuscular Dextrose Injection for Management of Refractory Bell's Palsy A Prospective Study
- ClinicalTrials.gov ID
- NCT07728331
- Acronym / sponsor ID
- 2023031799
- Conditions
- Bell Palsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 27 Jul 2026 (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 (BP) is characterized by idiopathic acute weakness of the facial muscles associated with compression of the facial nerve. The present prospective study sought to evaluate the clinical efficacy of ultrasound-guided combined perineural and intramuscular dextrose injection for management of refractory Bell's palsy. The study included 30 patients with Bell's palsy with House-Brackmann scale ≥ 3 who were refractory to standard medical treatment after 3 months of disease onset. They received ultrasound-guided combined perineural and intramuscular dextrose injection. Clinical outcome was assessed using the House-Brackmann scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Procedure: Ultrasound-guided combined perineural and intramuscular dextrose injection.Ultrasound-guided combined perineural and intramuscular dextrose injection. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The study included 30 patients with Bell's palsy diagnosed according to the recommendations of American Academy of Otolaryngology-Head and Neck Surgery Foundation
Key exclusion criteria (1 listed)
- Patients were excluded if they were previously submitted to injection therapy or surgical intervention for management of Bell's palsy. They were also excluded if they had associated mental illness or advanced systemic conditions (e.g. uncontrolled diabetes, uncontrolled hypertension, malignant disease, immunocompromised conditions).
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 |
|---|---|---|
| Ultrasound-guided combined perineural and intramuscular dextrose injection.Ultrasound-guided combined perineural and intramuscular dextrose injection. | Procedure or surgery | Interventional arm |
Primary outcome
House Brackmann scale
Time frame: 3 months
House Brackmann scale
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 27 Jul 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-guided combined perineural and intramuscular dextrose injection. in people with Bell Palsy, run by Al-Azhar University at 1 site in Egypt.
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 1 inclusion and 1 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 27 Jul 2026. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
House Brackmann scale (time frame: 3 months). 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 27 Jul 2026.