Randomized, Single-blind Comparison of Three Commercially Available Botulinum Neuromodulators in the Management of Facial Synkinesis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Change in Synkinesis Assessment Questionnaire (SAQ) Scores
研究概览
简要总结
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.
详细描述
Quality assurance:
Data is entered in to a spreadsheet as it is extracted exactly from the electronic medical record. During review of the findings, the data is again checked against the medical record to ensure accuracy. Botulinum toxin types are also verified with scanned copies of the botulinum toxin injection sheet which is filled out and scanned in to the medical record at the time of treatment.
Data dictionary:
Not necessary as limited new terminology is used and all understood among the research group. Additional terminology is clearly described for the trial participants and described in the manuscript reporting the results of the study.
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Facial synkinesis
排除标准
- •Previous complication from botulinum toxin neuromodulator injection
- •Inability to understand or complete the SAQ survey
- •Inability to participate in follow-up
- •Pregnancy
研究组 & 干预措施
OnabotulinumtoxinA Injectable Product
onabotulinumtoxinA (Botox®, Allergan) administered for n=15 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
干预措施: OnabotulinumtoxinA Injectable Product (Drug)
AbobotulinumtoxinA Injectable Product
abobotulinumtoxinA (Dysport®, Medicis) administered for n=13 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
干预措施: AbobotulinumtoxinA Injectable Product (Drug)
Incobotulinumtoxin A Injectable Product
incobotulinumtoxinA (Xeomin®, Merz) administered for n=10 total treatments. Each patient in this arm was administered the Synkinesis Assessment Questionnaire (SAQ) to assess severity of synkinesis pre-treatment. SAQ was administered again at 1, 2, and 4 weeks post-treatment and improvements were compared to the other arms of the study.
干预措施: Incobotulinumtoxin A Injectable Product (Drug)
结局指标
主要结局
Change in Synkinesis Assessment Questionnaire (SAQ) Scores
时间窗: 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).
次要结局
- Adverse Events(Up to 4 weeks post-treatment. Recorded at pre-treatment, 1 week, 2 weeks, and at 4 weeks.)