Leukocyte and Platelet Rich Plasma Versus Type A Botulinum Toxin Versus Glucocorticoids for the Treatment of Lateral Epicondylalgia: a Randomized, Multicenter, Double-blind, Therapeutic Trial With Three Parallel Arms
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Visual analog scale (VAS) for pain over the last 24 hours
研究概览
简要总结
The primary objective of this study is to compare the evolution of pain profiles among patients suffering from lateral epicondyalgia (tennis elbow) following three types of treatment: PRP-L injection versus type A botulinum toxin injection versus corticoid injection.
详细描述
The secondary objectives are to compare the following among the three groups:
A- The global efficacy of each treatment defined by a minimum reduction of 25% in average pain over the last 24 hours between 0 and 6 months.
B- The evolution of average pain over the last 24 hours between 0 and each different time frame (3 weeks, 6 weeks, 3 months and 6 months).
C- The evolution of maximum pain scores using nocturnal post-effort (Jamar grip test) visual analog scales (VAS) between day 0, 3 weeks, 6 weeks, 3 months and 6 months.
D- The perception of change on the Patient's Global Impression of Change score (PGIC) at 3 and 6 months E- The evolution of PRTEE scores at 0, 3 and 6 months F- Adverse events at 3 weeks, 6 weeks, 3 months and 6 months. G - Quality of life and utility via the SF-12 at 3 and 6 months. H- The consumption of analgesics.
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 (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PRP-L Group
Patients randomized to this group will be treated with an injection of Leukocyte and Platelet Rich Plasma (PRP-L).
Intervention: PRP-L Injection
干预措施: PRP-L Injection (Drug)
Botox Group
Patients randomized to this group will be treated with an injection of Type A Botulinum Toxin (Xeomin®, MERZ).
Intervention: Botox injection
干预措施: Botox injection (Drug)
Corticoid Group
Patients randomized to this group will be treated with an injection of Corticoids.
Intervention: Corticoid injection
干预措施: Corticoid injection (Drug)
结局指标
主要结局
Visual analog scale (VAS) for pain over the last 24 hours
时间窗: 6 months versus Baseline (day 0)
score varying from 0 to 10
次要结局
- Visual analog scale for pain over the last 24 hours(3 months)