Radial Extracorporeal Shock Wave Versus Botulinum Toxin A in the Treatment of Post-Stroke Upper Limb Spasticity: A Randomized Non-Inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The change of spasticity of elbow
研究概览
简要总结
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
详细描述
Botulinum toxin type A (BoNT-A) is widely used in the clinics to reduce spasticity and improve upper limb function for post-stroke patients. However, the treatments of BoNT-A injection are associated with high cost and invasive treatment. Recent studies have showed that radial extracorporeal shock wave (rESWT) is a novel, effective and safety treatment method for the spasticity. However, there were no studies to compare the effect of rESWT and BoNT-A injection for treatment on spasticity.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18-80 year-old
- •The onset of stroke must be at least 6 months previously
- •Spasticity measured as Modified Asthow Scale more(MAS) than 1+
- •Signed informed consent form
排除标准
- •Patients with marked contractures in the elbow and wrist (MAS>4)
- •Resistant hypertension, coagulation disorders, malignant tumors, pregnancy, pacemakers, cognitive disorders
- •Prior or planned treatment with phenol or alcohol nerve blocks, intrathecal baclofen, or BoNT-A injection within the six months preceding the study
研究组 & 干预措施
shock wave
The interventions were focused in the hypertonic muscles of the upper limb of 3000 impulses, a pressure of 1.5 bar and frequency of 5Hz were used to treat the biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.
干预措施: Shock Wave (Device)
Botulinum toxin A
We performed BoNT-A 500 unit in 2cc 0.9% normal saline at biceps brachii, flexor carpi ulnaris and flexor carpi radialis, mainly in the middle of the belly.
干预措施: Botulinum toxin A (Drug)
结局指标
主要结局
The change of spasticity of elbow
时间窗: Between baseline and 4 weeks post-treatment
Modified Ashworth Scale (MAS) for spasticity
次要结局
- The change of Tardieu scale scores for the elbow and wrist(Between baseline and 1, 4,8 weeks post-treatment)
- The change of upper limb function(Between baseline and 1,4,8 weeks post-treatment)
研究者
Gwo-Chi Hu,PHD
PHD
Mackay Memorial Hospital