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NCT Number: NCT04353908

Collagen Treatment in Facial Nerve Palsy

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.

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Key information

Conditions

Facial Nerve Palsy Bell Palsy Cranial Nerve Diseases DNA Virus Infections Facial Nerve Diseases Herpesviridae Infections Infections Mouth Diseases Nervous System Diseases Stomatognathic Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNITER ONLUS for balance and rehabilitation research

Guidonia, Rome, 00012, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rehabilitation

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

Other names: Kabat procedure

Collagen Injection

Procedure

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

Primary outcomes

  1. duration of voluntary activity

    Time frame: 2 months

    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

Secondary outcomes

  1. Facial asymmetry

    Time frame: 2 months

    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. Subjective facial disability

    Time frame: 2 months

    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.

Sponsors and collaborators

Lead sponsor

Uniter Onlus

Other

Collaborators

  • University of Rome Tor Vergata

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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