Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest
研究概览
简要总结
The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.
详细描述
Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.
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
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
- •Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis.
- •Symptom duration: should be at least 6 months.
- •Previous trial of complete course of physiotherapy and corticosteroid injection.
排除标准
- •Rheumatoid arthritis
- •Generalized polyarthritis
- •Local elbow arthritis
- •Simultaneous medial epicondylalgia
- •Bilateral lateral epicondylitis
- •Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures)
- •The use of corticosteroid in last 30 days
- •Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study
- •Pregnancy
- •Breast-feeding
- •Previous hand surgery
- •Having a hobby or job that needs finger extension
研究组 & 干预措施
B
干预措施: NaCl 0.9% (Drug)
A
干预措施: Botulinum Toxin A (Drug)
结局指标
主要结局
Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest
时间窗: 4 months
次要结局
- Patients subjective feeling of improvement.(4 months)
- Tenderness on lateral epicondyle(4 months)
- Pain sensation on resisted wrist extension, and passive wrist flexion(4 months)
- Pain-free grip strength, and pinch strength(4 months)
- Maximal grip strength, and pinch strength(4 months)