Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy
NCT ID: NCT06213415
Last Updated: 2024-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2024-02-29
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oral steroids
Oral steroids only
Corticosteroid
Oral steroids plus intratympanic injection
Oral steroids plus intratympanic injections
Oral steroids plus intratympanic injections
Corticosteroid
Oral steroids plus intratympanic injection
Interventions
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Corticosteroid
Oral steroids plus intratympanic injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mohamed Alaa Abd-Alraheem
Resident doctor
Principal Investigators
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Ahmed Ragab sayed
Role: STUDY_DIRECTOR
Board membership
Central Contacts
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References
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Agostini F, Mangone M, Santilli V, Paoloni M, Bernetti A, Saggini R, Paolucci T. Idiopathic facial palsy: umbrella review of systematic reviews and meta-analyses. J Biol Regul Homeost Agents. 2020 Jul-Aug;34(4):1245-1255. doi: 10.23812/20-339-A.
Chang CWD, McCoul ED, Briggs SE, Guardiani EA, Durand ML, Hadlock TA, Hillel AT, Kattar N, Openshaw PJM, Osazuwa-Peters N, Poetker DM, Shin JJ, Chandrasekhar SS, Bradford CR, Brenner MJ. Corticosteroid Use in Otolaryngology: Current Considerations During the COVID-19 Era. Otolaryngol Head Neck Surg. 2022 Nov;167(5):803-820. doi: 10.1177/01945998211064275. Epub 2021 Dec 7.
Hernandez-Trejo AF, Cuellar-Calderon KP, Trevino-Gonzalez JL, Yamamoto-Ramos M, Campos-Coy MA, Quiroga-Garza A, Guzman-Avilan K, Elizondo-Riojas G, Elizondo-Omana RE, Guzman-Lopez S. Prevalence of facial canal dehiscence and other bone defects by computed tomography. Eur Arch Otorhinolaryngol. 2020 Oct;277(10):2681-2686. doi: 10.1007/s00405-020-06013-8. Epub 2020 May 7.
Inagaki A, Minakata T, Katsumi S, Murakami S. Concurrent Treatment With Intratympanic Dexamethasone for Moderate-Severe Through Severe Bell's Palsy. Otol Neurotol. 2019 Dec;40(10):e1018-e1023. doi: 10.1097/MAO.0000000000002377.
Volk GF, Schaede RA, Thielker J, Modersohn L, Mothes O, Nduka CC, Barth JM, Denzler J, Guntinas-Lichius O. Reliability of grading of facial palsy using a video tutorial with synchronous video recording. Laryngoscope. 2019 Oct;129(10):2274-2279. doi: 10.1002/lary.27739. Epub 2018 Dec 20.
Walker NR, Mistry RK, Mazzoni T. Facial Nerve Palsy. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549815/
Other Identifiers
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Steroid injection bell's palsy
Identifier Type: -
Identifier Source: org_study_id
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