Management of Popeye Sign With Botulinum Toxin After Tenotomy of the Long Head of the Biceps Tendon: a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- AZ Delta
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain change
研究概览
简要总结
Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.
详细描述
Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Précis: Double-blinded randomized controlled trial with 20 people. Randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the infiltration with botulinum toxin type A (BTX-A) or placebo that will be administered at the 2nd visit.
Objective: The primary objective is to assess the effectiveness of an infiltration with botulinum toxin in the biceps muscle after tenotomy of the long head of the biceps tendon for pain and disability reduction.
Endpoint: The primary endpoint is a pain reduction as measured by the Visual Analogue pain scale (VAS) and a reduced disability as measured by the quick DASH (Disabilities of the Arm, Shoulder and Hand).
Population: 20 people who underwent an arthroscopic tenotomy of the long head of the biceps tendon and are having post-operative pain in the biceps muscle.
Phase: 4
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glenoid labrum repair
- •Having bicipital pain that started after the tenotomy
排除标准
- •under 18 years of age
- •over 65 years of age
- •pregnancy or lactation
研究组 & 干预措施
Botulinum toxin
Infiltration with botulinum toxin
干预措施: Botulinum toxin type A (Drug)
Placebo
Infiltration with placebo or sterile saline
干预措施: Placebo (Other)
结局指标
主要结局
Pain change
时间窗: 3 months
VAS score: Visual Analogue Scale score of 0 to 10 with 0 indicating no pain and 10 the worst pain imaginable
Disability change
时间窗: 3 months
quick DASH: Disabilities of the Arm, Shoulder and Hand 0 (no disability) to 100 (most severe disability)
次要结局
未报告次要终点