The Use of Ultrasound for Botulinum Toxin Subscapularis Muscle Injection Guidance in Spastic Hemiplegic Shoulder Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- The Modified Ashworth scale (MAS)
研究概览
简要总结
The aim of the study is to describe the efficacy of a new approach to the subscapularis muscle under US guidance for the injection of botulinum toxin in patients that underwent a stroke suffering from hemiplegic shoulder pain.
Pain and spastic shoulder are common findings in hemiplegic patients following a stroke.
The pain interferes with rehabilitation prolonging hospitalization and is related with decreased quality of life.
There is a close relationship between spasticity of the subscapularis muscle and pain The patients show a clinical picture of adduction and internal rotation of the shoulder, elbow and wrist and fingers flexion with a limited external rotation of the shoulder.
The investigators suggest that paralyzing the subscapularis muscle with botulinum toxin may alleviate pain in the hemiplegic shoulder. Best produced when injected in a specific area of the muscle where a higher concentration of motor points exists.
详细描述
Treatment using injection of botulinum toxin to the subscapularis spastic muscle has been described in the literature and is a common practice in hemiplegic shoulder. The Injection technic in this pathology is described by using anatomical landmarks of the shoulder region without using medical imaging.
On the other hand, injections to the subscapularis muscle has also been described using ultrasound guidance but not for this specific pathology.
There are no evidence-based guidelines describing us guided spastic subscapularis muscle injection. Injecting this muscle while in its spastic state requires a modulated approach Harrison et.al described cadaveric dissections of the subscapularis muscle and proposed a technique to reach the motor point zone of this muscle In our study the investigators follow the injection description published by Dong Wook Rha on cadavers based on Harrison's lateral approach description. The Ultrasound enables a correct identification of the target muscle avoiding possible complication of vessel or pulmonary puncture In our study the investigators will try to prove the efficacy of the lateral approach to the subscapularis muscle using ultrasound and nerve stimulator
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post stroke patients
- •Complaints of pain in hemiplegic shoulder
- •Spasticity of subscapularis muscle
- •Hebrew speakers
排除标准
- •Allergy to botulinum toxin
- •Pregnant women
结局指标
主要结局
The Modified Ashworth scale (MAS)
时间窗: The MAS will be assessed twice: the first time before the injection and the second time, in order to assess change from baseline measure, two weeks following the injection
measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. * 0: No increase in muscle tone * 1: Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM * 2: More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension
次要结局
- The Fugl-Meyer Assessment (FMA)(The FMA will be assessed twice: the first time before the injection and the second time two weeks following the injection)
- Visual Analogue Scale (VAS)(The VAS will be assessed twice: the first time before the injection and the second time two weeks following the injection)
- The Brief Pain Inventory - Short Form (BPI-sf)(The BPI-sf will be assessed twice: the first time before the injection and the second time two weeks following the injection)
研究者
Motti Ratmansky, MD
Director of the pain unit
Loewenstein Hospital