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European Journal of Physical and Rehabilitation Medicine 2021 June;57(3):366-75

DOI: 10.23736/S1973-9087.20.06393-5


language: English

Combination of in-situ collagen injection and rehabilitative treatment in long-lasting facial nerve palsy: a pilot randomized controlled trial

Alessandro MICARELLI 1, 2 , Andrea VIZIANO 3, Ivan GRANITO 2, Giuseppe ANTONUCCIO 2, Alessio FELICIONI 2, Marco LOBERTI 4, Pasquale CARLINO 2, Riccardo X. MICARELLI 3, Marco ALESSANDRINI 3

1 Institute of Mountain Emergency Medicine, Eurac Research, Bolzano, Italy; 2 ITER Center for Balance and Rehabilitation Research (ICBRR), Rome, Italy; 3 Department of Clinical Sciences and Translational Medicine, Tor Vergata University, Rome, Italy; 4 DOPSITERE, Rome, Italy

BACKGROUND: Many rehabilitative attempts have been made to prevent or reduce residual deficits in patients with established and long-term facial palsy (FP). In many clinical settings in-situ injection of collagen-based medical devices have been demonstrated to provide nutritional support for tissues.
AIM: To test the effectiveness of a collagen-based treatment for patients complaining of long standing FP, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method) (group A), compared to a FP group only undergoing the Kabat method (group B).
DESIGN: Randomised controlled trial.
SETTING: Tertiary referral outpatient center and University Hospital.
POPULATION: Forty-one patients with a medical diagnosis of long-term unilateral peripheral FP.
METHODS: Twenty-one Group A patients were compared, after randomization, to nineteen matched group B patients after 8 weeks of treatment. The outcomes were electromyographic findings, validated questionnaires (Facial Disability Index, FDI and General health-related quality of life assessment, QOL) and clinical grading (House-Brackmann, HB, and synkinesis grading scale). A correlation analysis was performed between pre-/post-treatment differences (Δ) in outcome and clinical-demographic measures.
RESULTS: A significant within-subjects improvement, both in electrophysiological and questionnaire scores, was found in both groups. When compared with group B, group A patients exhibited a significant reduction of post-treatment polyphasic potentials of voluntary activity of orbicularis oculi (P=0.017) and oris (P=0.015) and a significant increase in post-treatment duration of voluntary activity of orbicularis oris (P=0.018). Group A subjects demonstrated a significant improvement in questionnaire subscales regarding overall disease perception. Although positive correlations between the ∆FDI and ∆percentage of polyphasic potentials of voluntary activity were found in both groups, negative correlations in group A were found between disease duration and ∆duration of voluntary activity of orbicularis oculi and oris.
CONCLUSIONS: The combination of physical rehabilitative procedures with in-situ collagen injections, possibly acting in redirecting the phenomena of reinnervation/reorganization, demonstrated encouraging results in patients affected by long term FP.
CLNICAL REHABILITATION IMPACT: In-situ collagen injection could be a safe option enlarging the ‘window of opportunity’ to improve the voluntary muscle contraction pattern and general and specific disability referred by patients affected by long standing FP.

KEY WORDS: Facial paralysis; Rehabilitation; Collagen; Electromyography

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