Randomised Controlled Clinical Trial on Pulsatile Cupping in Patients With Osteoarthritis of the Knee.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
研究概览
简要总结
The purpose of this exploratory randomised trial is to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control.
详细描述
Cupping is a traditional therapy in many cultures of the world and is used to treat osteoarthritis of the knee. In this randomised trial we want to study the effect of pulsatile cupping in osteoarthritis of the knee compared to waiting list control. Pulsatile cupping is administered by a special cupping machine (HeVaTec) with silicone cupping glasses to the knee joint. Pulsatile pressure is generated by a pump that generates vacuum.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee according ACR-criteria
- •X-ray classification minimum Kellgren-Lawrence criteria grade 2
- •Pain Intensity > 40 mm VAS
- •Only therapy with NSAIDin the last 4 weeks
- •Informed consent
排除标准
- •Use of anticoagulants (Phenprocoumon, Heparin)
- •Coagulopathy
- •Cupping in the last 12 months
- •Intraarticular injection of corticosteroids or NSAID into the knee joint in the last 4 months
- •Use of systemic corticosteroids in the last 4 weeks
- •Physical therapy, leeches or acupuncture in the last 4 months
- •Other CAM therapies for the osteoarthritis in the last 4 weeks
- •Arthroscopy of the knee joint in the last 12 months
- •Paracetamol allergy or intolerance
研究组 & 干预措施
Waiting list
In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.
Cupping
In case of acute pain patients may take paracetamol as rescue medication, maximum dosage 2 gram per day.
干预措施: Pulsatile cupping (Device)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Score
时间窗: 4 weeks
次要结局
- Western Ontario and McMaster Universities Osteoarthritis (WOMAC) - Scores(12 weeks)
- Pain Intensity (Visual Analogue Scale; no pain=0; maximum pain=100 mm)(week 4 and 12)
- Quality of Life (SF 36)(4 and 12 weeks)
- Adverse events and serious adverse events(continously)
- Global assessment of efficacy by patients(week 4 and 12)
- Use of rescue medication (paracetamol)(weeks 1-4)
研究者
Benno Brinkhaus
Prof. MD
Charite University, Berlin, Germany