NCT03020368终止不适用
Effectiveness and Safety of Breeded Leech "Medileech" by BioRepro GmbH for Symptomatic Primary Arthrosis of the First Carpometacarpal Joint: a Randomized Controlled Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH)
研究概览
简要总结
In this trial the investigators want to prove the efficacy and safety of a one-time topical leech application at patients with symptomatic primary arthrosis of the first carpometacarpal joint in comparison to the standard therapy with topical diclofenac.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 35 to 85 years
- •Pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the VAS of 0 to 100 mm (relative to the last 24 hours)
- •Complaints for at least 3 months
- •X-ray Stadium Eaton I-IV at least once secured
排除标准
- •Anticoagulation (Marcumar, Heparin)
- •Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies
- •Combination therapy of ASA and thienopyridines
- •Pain medication with opioid analgesics
- •Systemic medication with corticoids or immunosuppressants
- •Intraarterticular injections or RSO within the last 3 months
- •Past or planned surgery on the affected joint in the next 2 months
- •Pregnancy, lactation
- •Insulin-dependent type I diabetes mellitus
- •Acute psychotic disorders
- •Severe comorbidity
研究组 & 干预措施
Leeches
Experimental
One-time topical application of 2-3 leeches ("medileech", Hirudo verbana) periarticularly on the painful thumb base
干预措施: Leeches (Biological)
Diclofenac
Active Comparator
3 times daily topical application of Diclofenac gel (1 g with 10 mg diclofenac-Na) over 4 weeks
干预措施: Diclofenac (Drug)
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: Change after 28 and 56 days
次要结局
- Visual analog scale (VAS)(Change after 7, 28 and 56 days)
- Medication on demand(Documentation between baseline and day 56)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
研究点 (1)
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