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

Not Applicable

Not yet recruiting

• Conditions: Bell Palsy
• Interventions: Drug: Corticosteroid

• Registration Number: NCT06213415
• Lead Sponsor: Assiut University

Brief Summary

intratympanic steroid injection bell's palsy

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-11-28
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Study Start: 2024-02
• Primary Completion: 2025-04
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral steroids	Corticosteroid	Oral steroids only
Oral steroids plus intratympanic injections	Corticosteroid	Oral steroids plus intratympanic injections

Primary Outcome Measures

Name	Time	Method
Success or failure of procedure to treat Bell's palsy	6 months	Degree of regaining function to facial nerve Unit of measurement : nerve conduction study; Measurement tool :endoscopic injection by ear microscope