NCT06190366招募中不适用
Effects of Bloodletting Acupuncture for Subacute and Chronic Non-specific Low Back Pain - a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change from baseline in average pain intensity in previous week
研究概览
简要总结
Evaluation of a bloodletting acupuncture at the fossa poplitea in comparison to bloodletting acupuncture at the regio glutaea and a waiting list control group in patients with subacute and chronic non-specific pain low back pain.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specialist confirmed diagnosis of subacute or chronic non-specific low back pain for at least 6 weeks prior to inclusion
- •Average pain intensity with at least 50 mm on the VAS from 0 to 100 mm
- •Exclusion criteria:
- •Serious illnesses
- •Poor general condition
- •Coagulation disorder, therapy with anticoagulants
- •Thrombophlebitis, skin inflammation in the area of the lower extremities
- •Alcohol, drug or medication addiction
- •Pregnancy
- •Lack of willingness to cooperate, linguistically or mentally unable to understand the contents of the study
- •Participation in another clinical trial during the study period
- •Starting a new therapy for the treatment of low back pain in the last 2 weeks
排除标准
- 未提供
结局指标
主要结局
Change from baseline in average pain intensity in previous week
时间窗: Baseline, 3 weeks
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
次要结局
- Change from baseline for days with pain medication use(Baseline, 3 weeks, 6 weeks)
- Change from baseline in average pain intensity in previous week(Baseline, 6 weeks)
- Change from baseline in average pain intensity of the last 24 hours(Baseline, 3 weeks, 6 weeks)
- Change from baseline for back pain specific disability(Baseline, 3 weeks, 6 weeks)
- Change from baseline in pain bothersomeness in previous week(Baseline, 3 weeks, 6 weeks)
- Change from baseline for health related quality of life(Baseline, 3 weeks, 6 weeks)
- Change from baseline for pain self-efficacy(Baseline, 3 weeks, 6 weeks)
- Change from baseline for work productivity(Baseline, 3 weeks, 6 weeks)
- Change from baseline for anxiety and depression(Baseline, 3 weeks, 6 weeks)
研究者
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
研究点 (2)
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