NCT04201249Unknown2 期
MILES STUDY - Mesotherapy In Lateral Epicondylitis, a Prospective Randomized Controlled Study
Hospital de Santa Maria, Portugal1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Pain intensity: visual analogue scale score
研究概览
简要总结
Investigate the short- and long-term efficacy and safety of intradermal NSAIDs and lidocaine (delivered through mesotherapy) for the treatment of LE comparing it with empty intradermal injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •clinical diagnosis defined as pain over the lateral epicondyle provoked by palpation;
- •A visual analogue scale (VAS) score for pain greater than 40mm;
- •symptoms duration for more than 1 month.
排除标准
- •other diseases that can alter clinical evaluation detected through history, clinical examination, ultrasound or other exams for comorbidities such as carpal tunnel syndrome, cervical radiculopathy, elbow arthritis, intra-articular loose bodies, previous elbow surgery or clinically significant or recent trauma, fibromyalgia and major psychiatric conditions;
- •VAS score for pain less than 40mm;
- •any of the following treatments during the previous 4 weeks before baseline visit: physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these: NSAIDS taken during the week previous to inclusion;
- •pregnancy;
- •allergy to any of the study drugs;
- •severely immunosuppressed patients;
- •known coagulopathies. During the study period, enrolled patients are not allowed to take oral corticosteroids, NSAIDs or receive any other medical intervention during the treatment period (physical therapy, bandage, mesotherapy and local corticosteroid injection or a combination of these).
研究组 & 干预措施
Mesotherapy with piroxicam and lidocaine
Active Comparator
干预措施: Piroxicam, lidocaine (Drug)
Mesotherapy without piroxicam and lidocaine
Sham Comparator
干预措施: Mesotherapy without drug administration (Device)
结局指标
主要结局
Pain intensity: visual analogue scale score
时间窗: 3 months
pain intensity quantified by using a 0-100 visual analogue scale (VAS) score; a higher score means a higher pain intensity on the VAS
次要结局
- Clinical and functional evaluation(0, 1, 2, 3 weeks and 6 months)
研究者
Vítor Teixeira
Vitor Teixeira
Hospital de Santa Maria, Portugal
研究点 (1)
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