Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial (BATCP)
2018年10月6日 更新者：Kristina Tedroff
The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.
研究概览
研究类型
介入性
注册 (实际的)
16
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Danderyd、瑞典、182 88
- Department of Rehabilitation Medicine at Danderyd Hospital AB
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Stockholm、瑞典、171 76
- Astrid Lindgren's Children's Hospital at Karolinska University Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age ≥ 18 years.
- Spastic Cerebral Palsy.
- Chronic pain, related to spastic muscle. Chronic pain defined as: 1)Recurring regional pain for at least three months AND 2)Pain intensity on average for the last 24 hours ≥3 on Numerical Rating Scale.
- Signed Informed consent.
Exclusion Criteria:
- Allergy/hypersensitivity to Dysport® or any of its components.
- Pregnancy.
- Women who breastfeed their children.
- Treatment with Botulinum toxin-A within the last five months.
- If there has been dose changes in any muscle-tone altering medication within two weeks of Visit 1.
- A clear degenerative cause behind the pain as elucidated by the clinical examination (e.g. history of osteoarthritis).
- Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Botulinum toxin-A (Dysport®)
Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
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Intramuscular injections in spastic muscle with regional muscle-related pain
其他名称：
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安慰剂比较：Normal saline
Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain
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Intramuscular injections in spastic muscle with regional muscle-related pain
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain intensity
大体时间：Six weeks after treatment
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Proportion of responders derived as reduction of intensity of pain of ≥2 points on the Numerical Rating Scale (NRS) at Visit 3 (six weeks after treatment) compared to baseline.
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Six weeks after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Use of other analgesic treatment
大体时间：Six weeks after treatment
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Categories of change in the use of analgesic treatments, derived as Increase, No change, or Decrease at Visit 3 (six weeks after treatment), compared to baseline.
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Six weeks after treatment
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Pain interference
大体时间：Six weeks after treatment
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Proportion of responders derived as a reduction in mean interference score of ≥1 on the Brief Pain Inventory (BPI-SF) at Visit 3 (six weeks after treatment) compared to baseline.
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Six weeks after treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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HRQoL (Health-Related Quality of Life)
大体时间：Six weeks after treatment
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Mean change at Visit 3 (six weeks after treatment) compared to baseline in the Short Form 36 v2 Health-related Quality of Life questionnaire (SF-36v2)
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Six weeks after treatment
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Global Impression of Change
大体时间：Six weeks after treatment
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Proportion of responders at Visit 3 (six weeks after treatment) in the Global Impression of Change Scale (PGIC) derived as at least "Minimally improved".
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Six weeks after treatment
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Fatigue Severity Scale
大体时间：Six weeks after treatment
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Proportion of responders at Visit 3 (six weeks after treatment) in the Fatigue Severity Scale (FSS) derived as a reduction in mean score of ≥1 point.
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Six weeks after treatment
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Spasticity
大体时间：Six weeks after treatment
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Proportion of responders at Visit 3 (six weeks after treatment) derived as achieving reduction of spasticity of >1 scale steps on the Modified Ashworth Scale (MAS)
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Six weeks after treatment
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Range of Motion
大体时间：Six weeks after treatment
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Proportion of responders at Visit 3 (six weeks after treatment) derived as improvement in passive joint range of motion (ROM) ≥ 10 degrees.
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Six weeks after treatment
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Adverse Events
大体时间：Six weeks after treatment
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Frequency of adverse events
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Six weeks after treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Kristina Tedroff, MD, PhD、Associate Professor, Department of Women's and Children's Health, Karolinska Institutet. Senior Consultant Physician, Astrid Lindgren's Children's Hospital, Stockholm, Sweden.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年8月1日
初级完成 (实际的)
2018年1月26日
研究完成 (实际的)
2018年10月5日
研究注册日期
首次提交
2015年4月30日
首先提交符合 QC 标准的
2015年4月30日
首次发布 (估计)
2015年5月5日
研究记录更新
最后更新发布 (实际的)
2018年10月9日
上次提交的符合 QC 标准的更新
2018年10月6日
最后验证
2018年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.