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临床试验/NCT03816787
NCT03816787Unknown不适用

Hemodynamic Changes During Dry Cupping Therapy on Low Back Pain

Chinese Academy of Medical Sciences0 个研究点目标入组 80 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
主要终点
Δ[HbO2]

研究概览

简要总结

This study aims to investigate the hemodynamic changes during dry cupping therapy (DCT) on low back pain. 50 patients with low back pain as experimental group and 50 healthy people as control group are treated by DCT. They will receive four consecutive WCT application in one month. Optical sensors were used to monitor the hemodynamic changes including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]) and the derived change in blood volume ([tHb]) in/surround the cupping sites during treatment. The investigators hope to interpret the curative effect of DCT from the perspective of modern hemodynamics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have had non-specific low back pains at least 12 weeks now.
  • Healthy people who are interested in dry cupping therapy

排除标准

  • Patients who have had non-specific low back pains at least 12 weeks now.
  • Healthy people who are interested in dry cupping therapy
  • Exclusion Criteria:
  • Patients who have low back pain due to specific and known etiological causes (infection, tumor, osteoporosis, ankylosing spondylitis, fracture, inflammatory process, radicular syndrome, cauda equinal syndrome).
  • Patients who are inappropriate to the wet cupping treatment.
  • AIDS, Active Hepatitis, Tuberculosis, Syphilis
  • Patients who regularly take anticoagulants, antiplatelet drugs
  • Anemia, thrombocytopenia
  • Hemorrhagic disease like hemophilia
  • Severe cardiovascular disease
  • Kidney diseases (renal failure, chronic renal disease)
  • Patients who have experiences of wet cupping treatment during last 3 months.
  • Patients who have had treatment for low back pain during last 2 weeks.
  • Patients who are in pregnancy or have plan to conception.
  • Patients who have vertebra surgery or have plan of surgery.
  • Patients who are inappropriate to join this trial judged by the radiologists or specialists.

研究组 & 干预措施

dry cupping for patients of low back pain

Experimental

Patients will receive four consecutive dry cupping therapy application in one month.

干预措施: Negative pressure therapy (Procedure)

dry cupping for health people

Active Comparator

Health people will receive four consecutive dry cupping therapy application in one month.

干预措施: Negative pressure therapy (Procedure)

结局指标

主要结局

Δ[HbO2]

时间窗: all groups: up to 4 weeks

the concentration changes of oxyhemoglobin (higher alternation means better curative effect)

Δ[Hb]

时间窗: all groups: up to 4 weeks

the concentration changes of deoxyhemoglobin (higher alternation means better curative effect)

次要结局

  • Δ[tHb](all groups: up to 4 weeks)
  • NRS(experimental group: up to 4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ting Li

Director

Chinese Academy of Medical Sciences

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