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Facial Nerve PalsyNCT04353908

Collagen Treatment in Facial Nerve Palsy

A study testing Rehabilitation and Collagen Injection in people with Facial Nerve Palsy, run by Uniter Onlus at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Facial Nerve Palsy
What is being tested?
Rehabilitation and Collagen Injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
Jul 2016to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • UNITER ONLUS for balance and rehabilitation research

    Guidonia, Rome, 00012

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
Rehabilitation, Collagen Injection
Keywords
Facial nerve palsy, Kabat method, Collagen injections, Electromyography
Medical subject headings
Bell Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RehabilitationProcedure or surgery

    Also called Kabat procedure

    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 InjectionProcedure or surgery

    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

Study groups in NCT04353908
Study groupRoleWhat they receive
kabatActive comparatorRehabilitation 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
Receives: Procedure: Rehabilitation
collagen injectionExperimentalInjections 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
Receives: Procedure: Rehabilitation; Procedure: Collagen Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 months

Secondary outcomes (2)

  1. 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).

    Measured: 2 months

  2. 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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study startJul 2016
  3. Primary completionMar 2019
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04353908
Sponsor's protocol ID
UniterCPF
Status last verified
Apr 2020
First submitted
16 Apr 2020
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20093325

  • 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.

    PubMed 25792936

  • 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.

    PubMed 19430987

  • 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.

    PubMed 23122676

  • 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.

    PubMed 26905565

  • 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.

    PubMed 18090862

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

    PubMed 22161401

Questions about this trial

What is this clinical trial studying?

A study testing Rehabilitation and Collagen Injection in people with Facial Nerve Palsy, run by Uniter Onlus at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

duration of voluntary activity (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04353908, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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