Botulinum Toxin A in the Treatment of Hemifacial Spasm

Study Overview
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Brief Summary
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Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups. Group A received unilateral injection while group B received bilateral injection. Patients completed follow-up A researcher record facial videos and analyzed facial symmetry and completed 3 scales.

Detailed Description
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Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups.Patients of unilateral group were injected to the affected side and the dose of botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site. 3 scales for measurement were used.

Official Title
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Does Bilateral Botulinum Toxin A in Patients With Hemifacial Spasm Improve Facial Symmetry Unilateral and Bilateral Injection of Botulinum Toxin A in Patients With Hemifacial Spasm? A Prospective, Randomized, Controlled Study

Conditions
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Hemifacial Spasm

Intervention / Treatment
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* Drug: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of hemifacial spasm Scott grading III to IV hemifacial spasm duration of half or more years last botulinum toxin A application at least 3 months before the start of the study Exclusion Criteria: history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression bilateral hemifacial spasm allergies to botulinum toxin A or to any component of the drug previous treatment with botulinum toxin A fewer than 3 months the use of drugs that could interfere with neuromuscular transmission or spasm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: unilateral injection group<br>Patients of unilateral group were injected botulinum toxin type A to the affected hemiface. | Drug: Botulinum Toxin Type A<br>* patients were injected to the normal side with dose of 1.25 units/per site<br>* Other names: Chinese botulinum toxin type A;|
| Experimental: bilateral injection group<br>Patients of bilateral group were injected botulinum toxin type A to the affected hemiface and normal hemiface. The intervention of the bilateral group was that the normal side was injected. | Drug: Botulinum Toxin Type A<br>* patients were injected to the normal side with dose of 1.25 units/per site<br>* Other names: Chinese botulinum toxin type A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sunnybrook Facial Grading System | Sunnybrook Facial Grading System consists of resting symmetry, symmetry of voluntary movement and synkinesis. Total score = Symmetry of voluntary movement score - Resting symmetry score - Synkinesis score | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symmetry Scale for Hemifacial Spasm | Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score | up to 6 months | 
| Facial Clinimetric Evaluation Scale | Facial Clinimetric Evaluation Scale consists of six parts:facial movement,facial comfort,oral function,eye comfort,lacrimal control and social function. Total score = facial movement + facial comfort + oral function + eye comfort + lacrimal control + social function. | up to 6 months | 
| The effective duration of botulinum toxin A | degree of amelioration in spasm and the effective duration of botulinum toxin A | up to 6 months | 
| Adverse events | Adverse events, including stiff face, difficulty drinking and eating, difficulty controlling parotid and so on.The onset and duration of adverse events.Whether to take intervention to ameliorate adverse events and the efficacy of the intervention | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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botulinum toxin A