A Study of Ultrasound-Guided Versus Anatomically Guided Botulinum Toxin Injection in Spasticity in Adults in Tanta University Hospitals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Assessment the range of movement
研究概览
简要总结
This study aimed to compare the safety and outcome of ultrasound (US)- guided botulinum toxin (BoNT) injection and anatomically guided injection in muscle spasticity of different causes in adults.
详细描述
One of the major complications of neurological diseases is spasticity which is defined as an increased velocity-dependent muscle tone.
A large volume of clinical data has demonstrated the efficacy and safety of botulinum toxin type A (BoNT-A) products for treating conditions such as spasticity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 old.
- •Both sexes.
- •Patients with muscle spasticity.
排除标准
- •Patients with contraindications to botulinum toxin injection as allergy, myasthenia gravis, and cerebral palsy.
研究组 & 干预措施
Botulinum toxin injection under anatomical landmark
Patients received botulinum toxin injections under the anatomical landmark.
干预措施: Botulinum toxin injection under anatomical landmark (Drug)
Ultrasound-guided botulinum toxin injection
Patients received ultrasound-guided botulinum toxin injection
干预措施: Ultrasound-guided botulinum toxin injection (Drug)
结局指标
主要结局
Assessment the range of movement
时间窗: 6 months after the procedure
The range of movement regarding forearm pronation, thumb flexion, ankle inversion and fingers flexion according to modified Ashworth scale (MAS): score zero indicate no increase in tone, score 1 indicate slight increase in tone, catch or release at end range of motion (ROM), score 1 + indicate a slight increase in tone catch, release, resistance through rest ROM (1/2 ROM), score 2 indicate more marked increase in tone through ROM but affected part moved easily, score 3 indicate a considerable increase in tone, passive movement difficult, score 4 indicate affected part in rigid flexion and extension. It was assessed after three and six months.
次要结局
- Assessment the quality of life(6 months after the procedure)
研究者
Omar Abdallah Ebrahim Elsaharty
Resident of Neuropsychiatry, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University