Clinical trial NCT06213415: Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy
Official title: Role of Oral Steroid Alone Versus Oral Steroid Plus Intratympanic Steroid Injection in Bell's Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bell Palsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Success or failure of procedure to treat Bell's palsy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Board membership
name: Ahmed Ragab sayed
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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.
citation: 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/