Eye Soft Surgery for Facial Sinkynesis

University of Catania

Status: Completed

Conditions: Sinkynesis; Facial Paralysis

Treatments: Procedure: Eye soft surgery; Other: Physical Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06538103

UniCT2022

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Treatment

Experimental group

Description:

Kabat therapy home NMR, and eyelid surgery at 90 days (if lagophthalmos with epiphora or ectropion was present)

Treatment:

Other: Physical Rehabilitation

Procedure: Eye soft surgery

Control

Active Comparator group

Description:

Kabat therapy and neuromuscular reeducation (NMR) at home

Treatment:

Other: Physical Rehabilitation