Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy

January 9, 2024 updated by: Ahmed Mohamed Alaa Abd-Alraheem, Assiut University
intratympanic steroid injection bell's palsy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Role of oral steroid alone versus oral steroid plus intratympanic steroid injection in Bell's palsy

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Mean Aged 18 years or more.

    • Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less.
    • Moderate to severe facial palsy [House-Brackmann grade IV or greater]

Exclusion Criteria:

  • Another cause of facial nerve paralysis that is not idiopathic.

    • Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome.
    • Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy.
    • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral steroids
Oral steroids only
Drug: Corticosteroid
Oral steroids plus intratympanic injection
Active Comparator: Oral steroids plus intratympanic injections
Drug: Corticosteroid
Oral steroids plus intratympanic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success or failure of procedure to treat Bell's palsy
Time Frame: 6 months

Degree of regaining function to facial nerve Unit of measurement : nerve conduction study

Measurement tool :endoscopic injection by ear microscope
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed Ragab sayed, Board membership

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

January 9, 2024

First Posted (Estimated)

January 19, 2024

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Steroid injection bell's palsy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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