NCT04115085进行中（未招募）不适用
Study of Medical Ultrasound for Rhizarthrosis
Waldfriede Hospital2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH)
研究概览
简要总结
It was never investigated which preservative non-invasive treatments are superior to treat rhizarthrosis. This randomized study compares the effect of 1. hand therapy vs. 2. therapeutic ultrasound vs. 3. hand therapy plus therapeutic ultrasound in the treatment of rhizarthrosis.
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
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 40 to 90 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
- •History of surgery on the affected hand, wrist or forearm
- •Planned surgery in the next 8 months
- •Anticoagulation (Marcumar, Heparin)
- •Haemophilia, V. Willebrandt Jürgens syndrome, thrombocytopathy and other blood anomalies
- •acute pain medication (<7 days)
- •Systemic medication with corticoids or immunosuppressants
- •Intraarterticular injections or RSO within the last 3 months
- •Pregnancy, lactation
- •Insulin-dependent type I diabetes mellitus
- •Significant cognitive impairment
- •clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study
- •Malignant disease
- •Simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion
- •Clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse)
- •Insufficient mental possibility of cooperation
- •Therapy with oral anticoagulants (e.g., Marcumar)
- •Suspected lack of compliance
- •Medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: Change after 9 weeks and 3, 4 and 8 months
Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)
次要结局
- Visual analogue scale (VAS) pain(Change after 9 weeks and 3, 4 and 8 months)
- Short Form 36 SF-36(Change after 9 weeks and 3, 4 and 8 months)
- Functional assessment: Thumb force(Change after 9 weeks and 3, 4 and 8 months)
- Functional assessment: Goniometry(Change after 9 weeks and 3, 4 and 8 months)
研究者
研究点 (2)
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