NCT04353908

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

2.7 years

First QC Date

April 16, 2020

Last Update Submit

April 16, 2020

Conditions

Facial Nerve Palsy

Keywords

Facial nerve palsyKabat methodCollagen injectionsElectromyography

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Facial asymmetry

    2 months

  • Subjective facial disability

    2 months

Study Arms (2)

kabat

ACTIVE COMPARATOR

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

collagen injection

EXPERIMENTAL

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: RehabilitationProcedure: Collagen Injection

Interventions

RehabilitationPROCEDURE

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

Also known as: Kabat procedure
collagen injectionkabat
Collagen InjectionPROCEDURE

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

collagen injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNITER ONLUS for balance and rehabilitation research

Guidonia, Rome, 00012, Italy

Location

Related Publications (7)

  • 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.

    PMID: 20093325BACKGROUND

  • 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.

    PMID: 25792936BACKGROUND

  • 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.

    PMID: 19430987BACKGROUND

  • 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.

    PMID: 23122676BACKGROUND

  • 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.

    PMID: 26905565BACKGROUND

  • 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.

    PMID: 18090862BACKGROUND

  • 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.

    PMID: 22161401BACKGROUND

MeSH Terms

Conditions

Bell Palsy

Interventions

RehabilitationCollagen

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsMouth DiseasesStomatognathic DiseasesFacial Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesBiopolymersPolymersMacromolecular SubstancesExtracellular Matrix ProteinsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

July 1, 2016

Primary Completion

March 1, 2019

Study Completion

March 1, 2020

Last Updated

April 21, 2020

Record last verified: 2020-04

Locations

IT(1)