Collagen Treatment in Facial Nerve Palsy

Facial Nerve Palsy Clinical Trial

Official title:

The Role of Collagen in the Rehabilitation of Peripheral Paralysis of the Facial Nerve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04353908
• Other study ID #: UniterCPF
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• Source: Uniter Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test the effectiveness of a collagen-based treatment for patients complaining of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method), compared to a group only undergoing the Kabat method.

Description:

Objective: To test the effectiveness of a collagen-based treatment for patients complaining of long standing facial nerve axonotmesis, who are following a proprioceptive neuromuscular facilitation protocol (Kabat method), compared to a group only undergoing the Kabat method.

Methods: Patients undergoing both procedures will be compared, after randomization, to matched patients undergoing only Kabat procedure after 8 weeks of treatment. The outcomes will be electromyographic findings, validated questionnaires (Facial Disability Index, FDI) and clinical grading (House-Brackmann, HB). A correlation analysis will be performed between pre-/post-treatment differences (Δ) in outcome and clinical-demographic measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• patients with a medical diagnosis of long-term unilateral peripheral axonotmesis of the facial nerve

Exclusion Criteria:

• patients with facial palsy caused by central nerve disease;

• patients with a history of recurrent facial palsy;

• patients with a facial skin disease hampering the possibility of injecting the drug; - patients with difficulty in moving their face due to previous plastic surgery or facial surgery;

• patients with systemic diseases that can affect facial electromyography;

• patients deemed inappropriate by the researchers.

• patients with a history of hypersensitivity to any collagen solution constituent or showing pregnancy, lactation, neuromuscular junction disorders (myastenia gravis), peripheral motor neuropathies, or active infections will be also excluded.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Nerve Diseases
• Facial Nerve Palsy
• Facial Paralysis
• Facies
• Paralysis

Intervention

Procedure:
• Rehabilitation
The Kabat procedure consists of facilitating the voluntary response of an impaired muscle through a global pattern of an entire muscular section which undergoes resistance. This method considers that harmony, coordination and optimal strength of body movements mainly depend upon the fact that they are performed following diagonal lines with respect to the sagittal axis of the body, thus implying a 'rotational' effect. It will performed twice a week for 8 weeks
• Collagen Injection
With an insulin-type syringe and 30-gauge needle, a bolus of about 0.4 cc per point of the collagen solution will be injected in the orbicularis oculi muscle 1 cm outside the orbital rim and 0.5 cm superior and inferior to the first injection point, respectively, and in the orbicularis oris muscle, where the 2 injection points are on the border between the pars peripheralis and pars marginalis, located about 5 mm above the superior and inferior vermilion, respectively

Locations

Country	Name	City	State
Italy	UNITER ONLUS for balance and rehabilitation research	Guidonia	Rome

Sponsors (2)

Lead Sponsor	Collaborator
Uniter Onlus	University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

References & Publications (7)

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. — View Citation

Cao J, Xiao Z, Jin W, Chen B, Meng D, Ding W, Han S, Hou X, Zhu T, Yuan B, Wang J, Liang W, Dai J. Induction of rat facial nerve regeneration by functional collagen scaffolds. Biomaterials. 2013 Jan;34(4):1302-10. doi: 10.1016/j.biomaterials.2012.10.031. Epub 2012 Oct 31. — View Citation

Grosheva M, Wittekindt C, Guntinas-Lichius O. Prognostic value of electroneurography and electromyography in facial palsy. Laryngoscope. 2008 Mar;118(3):394-7. — View Citation

Hg Beurskens C, Al Burgers-Bots I, W Kroon D, Ab Oostendorp R. Literature review of evidence based physiotherapy in patients with facial nerve paresis. J Jpn Phys Ther Assoc. 2004;7(1):35-9. doi: 10.1298/jjpta.7.35. — View Citation

Lindsay RW, Robinson M, Hadlock TA. Comprehensive facial rehabilitation improves function in people with facial paralysis: a 5-year experience at the Massachusetts Eye and Ear Infirmary. Phys Ther. 2010 Mar;90(3):391-7. doi: 10.2522/ptj.20090176. Epub 2010 Jan 21. — View Citation

Martin Martin LS, Massafra U, Bizzi E, Migliore A. A double blind randomized active-controlled clinical trial on the intra-articular use of Md-Knee versus sodium hyaluronate in patients with knee osteoarthritis ("Joint"). BMC Musculoskelet Disord. 2016 Feb 22;17:94. doi: 10.1186/s12891-016-0948-4. — View Citation

Teixeira LJ, Valbuza JS, Prado GF. Physical therapy for Bell's palsy (idiopathic facial paralysis). Cochrane Database Syst Rev. 2011 Dec 7;(12):CD006283. doi: 10.1002/14651858.CD006283.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of voluntary activity	An electromyography coaxial needle examination will be performed on the orbicularis oculi and orbicularis oris to evaluate the electrical alteration of these muscles. These muscles will be examined at rest and during voluntary activity in terms of msec of duration of voluntary activity	2 months
Secondary	Facial asymmetry	Static and dynamic facial asymmetry will be evaluated and manually tested on the muscle strength of the frontalis, corrugator, orbicularis oculi, zigomaticus, caninus, platysma and orbicularis oris muscles. These clinical findings will be classified and recorded according to the House-Brackmann (HB) scale, ranging from 1 (normal) to 6 (severe dysfunction).	2 months
Secondary	Subjective facial disability	The Facial Disability Index (FDI) is a 10-item self-administered questionnaire with 2 subscale scores: 5 items concern the physical function subscale, and 5 items concern the social/well-being function subscale. Each item is rated on a 6-point scale, ranging from severe disability to absence of disability. Both subscales are transformed to a score on a 100 point scale, with 100 indicating unimpaired physical or social/wellbeing function. All questions referred to the preceding month.	2 months