The Role of Collagen in the Rehabilitation of Peripheral Paralysis of the Facial Nerve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Facial Nerve Palsy
- Sponsor
- Uniter Onlus
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- duration of voluntary activity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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
- Subjective facial disability(2 months)
- Facial asymmetry(2 months)