Clinical trial NCT06538103: Eye Soft Surgery for Facial Sinkynesis
Official title: Combining Early Lower Eyelid Surgery With Neuromuscular Retraining for Synkinesis Prevention After Facial Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Paralysis
Sinkynesis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Facial synkinesis (FS) is a distressing sequela of facial palsy (FP) characterized by involuntary, simultaneous movements of facial muscles occurring during voluntary facial expressions. Treatment of synkinesis is challenging, and preventive methods are needed.

This study evaluates the efficacy of physical facial nerve rehabilitation (PFNR) therapy alone versus PNFR with eyelid surgery to correct lagophthalmos and prevent the onset of synkinesis.

25 outpatients are randomized to receive either PFNR alone (neuromuscular retraining and Kabat proprioceptive neuromuscular facilitation) or PNFR and early (90 days after FP onset) eyelid surgery (involving a conservative oculoplastic correction for lagophthalmos with epiphora or ectropion). Comprehensive otolaryngological assessments and Magnetic Resonance Imaging (MRI) will be conducted. Synkinesis progression was measured using Another Disease Scale (ADS) at baseline, 3 months 6 months, 12 months, and 24-months post-treatment. The data were analyzed with ANOVA, t-test, Chi-Square analyses.


Eligibility criteria: Inclusion Criteria:

* people over 18 years old
* willingness to participate
* acute/new onset of FP (less than 15 days)

Exclusion Criteria:

* neuro-inflammatory diseases (e.g., Multiple Sclerosis)
* FP from systemic disorders (e.g., Guillain-Barré syndrome, Lyme disease, encephalitis)
* FP from middle ear infections or untreated cholesteatoma
* severe cognitive or psychological disorders
* non-consent to participate in the study

Primary outcomes:
measure: Sinkinesis
timeFrame: 3, 6, 12, 24 months
Secondary outcomes:
measure: Recovery of Facial motility
timeFrame: 3, 6, 12, 24 months
measure: Time to recover facial motility
timeFrame: 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Arianna Di Stadio
state: Sicily
Study officials:
affiliation: UniCT
name: Arianna Di Stadio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Stadio A. Eyelid lifting for ectropion and scleral show in facial palsy disease. ORL J Otorhinolaryngol Relat Spec. 2014;76(6):329-35. doi: 10.1159/000369623. Epub 2015 Jan 8.
citation: Di Stadio A. Another Scale for the Assessment of Facial Paralysis? ADS Scale: Our Proposition, How to Use It. J Clin Diagn Res. 2015 Dec;9(12):MC08-11. doi: 10.7860/JCDR/2015/15366.6953. Epub 2015 Dec 1.
citation: Di Stadio A, Gambacorta V, Ralli M, Pagliari J, Longari F, Greco A, Ricci G. Facial taping as biofeedback to improve the outcomes of physical rehab in Bell's palsy: preliminary results of a randomized case-control study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1693-1698. doi: 10.1007/s00405-020-06193-3. Epub 2020 Jul 17.
citation: Monini S, Iacolucci CM, Di Traglia M, Lazzarino AI, Barbara M. Role of Kabat rehabilitation in facial nerve palsy: a randomised study on severe cases of Bell's palsy. Acta Otorhinolaryngol Ital. 2016 Aug;36(4):282-288. doi: 10.14639/0392-100X-783.
citation: Barbara M, Antonini G, Vestri A, Volpini L, Monini S. Role of Kabat physical rehabilitation in Bell's palsy: a randomized trial. Acta Otolaryngol. 2010;130(1):167-72. doi: 10.3109/00016480902882469.