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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06213415
Other study ID # Steroid injection bell's palsy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2024
Est. completion date November 2026

Study information

Verified date January 2024
Source Assiut University
Contact Ahmed Mohamed Alaa
Phone 01007575074
Email Drahmedm.alaaa@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

intratympanic steroid injection bell's palsy


Description:

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date November 2026
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Corticosteroid
Oral steroids plus intratympanic injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Walker NR, Mistry RK, Mazzoni T. Facial Nerve Palsy. 2023 Jul 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK549815/ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Success or failure of procedure to treat Bell's palsy Degree of regaining function to facial nerve Unit of measurement : nerve conduction study
Measurement tool :endoscopic injection by ear microscope
6 months
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