Collagen Treatment in Facial Nerve Palsy

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

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.

Study Overview

• Status: Completed
• Conditions: Facial Nerve Palsy
• Intervention / Treatment: Procedure: Rehabilitation; Procedure: Collagen Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome
    • Guidonia, Rome, Italy, 00012
      • UNITER ONLUS for balance and rehabilitation research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: kabat; Rehabilitation will be started in both groups of patients and it will be carried out according to Kabat et al., i.e. a proprioceptive neuromuscular facilitation procedure, twice a week for 8 weeks, by an experienced physioptherapist	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; Other Names: Kabat procedure
Experimental: collagen injection; Injections of an equally-balanced solution of MD Neural, MD Matrix and MD Muscle (Guna S.p.a., Milan-Italy), containing collagen of porcine origin, will be administered subcutaneously after applying lidocaine/prilocaine cream on the affected side, by a skilled otonaryngologist in the field of injection treatments, twice a week for 8 weeks	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; Other Names: Kabat procedure; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Uniter Onlus
• Collaborators: University of Rome Tor Vergata

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Grosheva M, Wittekindt C, Guntinas-Lichius O. Prognostic value of electroneurography and electromyography in facial palsy. Laryngoscope. 2008 Mar;118(3):394-7. doi: 10.1097/MLG.0b013e31815d8e68.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 16, 2020
• First Posted (Actual): April 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Electromyography; Facial nerve palsy; Kabat method; Collagen injections
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Bell Palsy; Facial Paralysis; Facies; Facial Nerve Diseases
• Other Study ID Numbers: UniterCPF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No