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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-11-30

Brief Summary

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intratympanic steroid injection bell's palsy

Detailed Description

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

Conditions

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Bell Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Oral steroids

Oral steroids only

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

Oral steroids plus intratympanic injection

Oral steroids plus intratympanic injections

Oral steroids plus intratympanic injections

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

Oral steroids plus intratympanic injection

Interventions

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Corticosteroid

Oral steroids plus intratympanic injection

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Alaa Abd-Alraheem

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Ragab sayed

Role: STUDY_DIRECTOR

Board membership

Central Contacts

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Ahmed Mohamed Alaa

Role: CONTACT

01007575074

Hussein Farid mostafa wishahi

Role: CONTACT

01001775898

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.

Reference Type BACKGROUND
PMID: 32935528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34874793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32383094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31469789 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30570149 (View on PubMed)

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/

Reference Type BACKGROUND
PMID: 31747222 (View on PubMed)

Other Identifiers

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Steroid injection bell's palsy

Identifier Type: -

Identifier Source: org_study_id

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