Hemifacial Spasm
Conditions
Keywords
botulinum toxin A
Brief summary
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
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.
Interventions
DRUGBotulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site
Sponsors
Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sunnybrook Facial Grading System | up to 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symmetry Scale for Hemifacial Spasm | up to 6 months | Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score |
| Facial Clinimetric Evaluation Scale | up to 6 months | 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. |
| The effective duration of botulinum toxin A | up to 6 months | degree of amelioration in spasm and the effective duration of botulinum toxin A |
| Adverse events | up to 6 months | 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 |
Countries
China
Contacts
Primary ContactLingjing Jin, PhD
Backup ContactLibin Xiao, MBA
Outcome results
None listed