Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Botulinum toxin-A (Dysport®)
Intramuscular injections of Botulinum toxin-A in spastic muscles with regional muscle-related pain
干预措施: Dysport® (Drug)
Normal saline
Intramuscular injections of normal saline solution in spastic muscles with regional muscle-related pain
干预措施: Normal saline (Drug)
结局指标
主要结局
Pain intensity
时间窗: Six weeks after treatment
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.
次要结局
- Pain interference(Six weeks after treatment)
- Use of other analgesic treatment(Six weeks after treatment)
研究者
Kristina Tedroff
MD, PhD. Associate Professor. Senior Consultant Physician.
Karolinska Institutet