NCT02090686已完成不适用
Efficacy of Pulsatile Cupping in Patients With Chronic Low Back Pain - a Randomized Controlled Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Intensity of pain on visual analogues scale
研究概览
简要总结
The purpose of this study is to determine whether pulsatile cupping with a cupping device is effective in the treatment of patients with chronic low back pain compared to no cupping or to minimal cupping.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Male and female, 18-65 years
- •Chronic low back pain (disease duration > 3 months)
- •Pain intensity on visual analogue scale at inclusion > 40 mm (0-100 mm scale)
- •Only pharmacological treatment with NSAID or no treatment in the last 4 weeks
- •Undersigned informed consent form
排除标准
- •Use of anticoagulants (Phenprocoumon, Heparin)
- •Coagulopathy
- •Cupping in the last 6 weeks
- •Other CAM therapies in the last 12 weeks (e.g. acupuncture)
- •Physical therapy in the last 12 weeks (e.g. massage, osteopathy)
- •participation in another study in the last 3 months
- •Paracetamol allergy or intolerance
- •Pathological neurological symptoms such as muscular paralysis or paraesthesia due to spinal disc herniation or other causes
- •Known renal and / or hepatic diseases
- •Intake of central nervous system-acting analgesics in the last 6 weeks
- •Applying for early retirement due to low back pain
- •Severe disease that does not allow participation
- •No undersigned informed consent form
研究组 & 干预措施
Pulsatile Cupping
Active Comparator
干预措施: Pulsatile Cupping (Device)
No Intervention
No Intervention
Waiting list
Minimal Cupping
Active Comparator
干预措施: Minimal Cupping (Device)
结局指标
主要结局
Intensity of pain on visual analogues scale
时间窗: 4 weeks
次要结局
- Intensity of pain on visual analogue scale(12 weeks)
- Back function - FFbH-R-Questionnaire(4 weeks, 12 weeks)
- Quality of Life - SF 36(4 weeks, 12 weeks)
- Assessment of perceived effect on Likert Scale(4 weeks, 12 weeks)
- Intake of paracetamol(4 weeks)
- Adverse events(week 1- 12)
研究者
Benno Brinkhaus
Prof.
Charite University, Berlin, Germany
研究点 (1)
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