An interventional study of Rehabilitation and Collagen Injection in Facial Nerve Palsy, sponsored by Uniter Onlus. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Uniter Onlus · Not applicable, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.
This study's enrollment of 40 is close to the median of 42 across 70 interventional studies indexed under Bell Palsy.
Browse Bell Palsy studies →Uniter Onlus is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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: Rehabilitation · Procedure: Collagen Injection
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
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
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
Time frame: 2 months
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).
Time frame: 2 months
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.
Time frame: 2 months
Ran from Jul 2016 to primary completion in Mar 2019, 32 months.
Of 38 non-industry interventional studies with no phase under Bell Palsy, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 25. This study's 32 months is above that.
Counting every sponsor, half of 40 studies reached it within 10 months; a quarter within 3 and three quarters within 21.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Uniter Onlus