Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin for the Treatment of Muscle Spasm Associated With Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Safety of injection
研究概览
简要总结
Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as those given at 12-week or longer intervals. We also hypothesize that for those patients who would prefer a shorter inter-injection interval, but for whom their insurance carrier has prevented this, have worse health-related quality of life compared to patients who receive injections at a 10-week or shorter interval. We aim to investigate this hypothesis by collecting demographic and injection data and patient survey responses.
详细描述
Our project has the following aims:
Aim 1: to determine if any difference exists in safety or efficacy between patients receiving injections of botulinum toxin at 10-week or shorter intervals as compared to patients receiving injections at 12-week or longer intervals.
Aim 2: to determine if patients who have expressed a preference for injections at 10 week or shorter intervals but whose insurance carriers have mandated a 12-week interval have worse health related quality of life as compared to patients who are receiving injections at 10-week or shorter intervals.
This project consists of two analyses, each designed to accomplish aims 1 and 2. For both aims, we will invite consecutive patients who meet entry criteria to participate who are followed in the botulinum toxin injection clinics of the University of Texas Southwestern Medical Center movement disorders faculty. Participants who consent to data collection by participating in an email-administered survey of quality of life will have their medical records reviewed by an investigator for abstraction of clinical data (to include dose, injection site, injection interval, side effects, demographics, and diagnoses). Additionally, patients will fill out two or more survey instruments on the date of their enrollment visit following their botulinum toxin injection visit. The survey instruments completed will be 1) the SF-36 health questionnaire and 2) a disease-specific HRQoL survey chosen to be applicable to the specific condition for which that subject is receiving botulinum toxin injections. Patients receiving injections for multiple conditions will receive surveys for each condition for which they are receiving treatment. The disease specific scales to be used selectively depending on the patient's specific condition include:
- Blepharospasm disability index
- Craniocervical dystonia questionnaire (CDQ-24)
- Arm dystonia disability scale (ADDS)
- Hemifacial spasm scale (HSF-7)
- Oromandibular dystonia questionnaire (OMDQ-25)
- Spasticity scale (SQoL-6D)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •For both Aims 1 and 2:
- •Patient is unwilling to consent to study procedures (refuses to fill out surveys)
- •Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency
- •Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist
- •Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed
结局指标
主要结局
Safety of injection
时间窗: single measure at 1 day of enrollment
Side effects recorded qualitatively and graded by severity (0 to 4 numerical subjective grade where 4 is most severe) by the injecting physician and attributed by that physician to the most recent injection
Quality of Life measured by Short Form 36 (SF-36)
时间窗: single measure at 1 day of enrollment
SF-36 HRQoL score as collected by a patient-completed survey (measured from 0 to 100 with a scoring system where 100 is best quality of life)
次要结局
- Blepharospasm disability index survey (BSDI)(single measure at 1 day of enrollment)
- Cervicocranial dystonia questionnaire (CDQ24)(single measure at 1 day of enrollment)
- Arm Dystonia Disability Scale (ADDS)(single measure at 1 day of enrollment)
- Hemifacial Spasm Scale (HFS7)(single measure at 1 day of enrollment)
- Spasticity Quality of Life scale (SQoL-6D)(single measure at 1 day of enrollment)
- Oromandibular dystonia questionnaire (OMDQ-25)(single measure at 1 day of enrollment)
研究者
Richard Dewey
Professor of Neurology
University of Texas Southwestern Medical Center