Collagen Treatment in Facial Nerve Palsy

Uniter Onlus

Status: Completed

Conditions: Facial Nerve Palsy

Treatments: Procedure: Rehabilitation; Procedure: Collagen Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04353908

UniterCPF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

kabat

Active Comparator group

Description:

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

Treatment:

Procedure: Rehabilitation

collagen injection

Experimental group

Description:

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

Treatment:

Procedure: Rehabilitation

Procedure: Collagen Injection