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Randomized, Single-blind Comparison of Three Commercially Available Botulinum Neuromodulators in the Management of Facial Synkinesis
The purpose of this study is to compare the effectiveness of three commercially available botulinum toxin neuromodulators in the treatment of facial synkinesis using patient reported outcome measures.
Details
| Lead sponsor | University of Utah |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 71 |
| Start date | 2012-07 |
| Completion | 2015-03 |
Conditions
- Facial Nerve Injuries
- Facial Paresis Associated With Facial Nerve Dysfunction
- Facial Asymmetry
- Synkinesis
Interventions
- OnabotulinumtoxinA Injectable Product
- AbobotulinumtoxinA Injectable Product
- Incobotulinumtoxin A Injectable Product
Primary outcomes
- Change in Synkinesis Assessment Questionnaire (SAQ) Scores — Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.
The previously validated instrument, Synkinesis Assessment Questionnaire (SAQ), was administered in order to evaluate patient-perceived severity of synkinesis. This instrument was used for each of the three treatment arms and change in scores from baseline were compared at each time point between arms. SAQ scores are calculated as the sum of scores for 9 questions, which each is scored from 1 to 5, divided by 45 and multiplied by 100. The total score therefore can range from 20 to 100. Lower SAQ scores represent less severe facial synkinesis, and higher scores more severe. We report here the mean total SAQ score each group. For additional information on the SAQ for facial synkinesis see Mehta et al. published in Laryngoscope in May 2007 (PMID: 17473697).