跳至主要内容
临床试验/NCT06073379
NCT06073379已完成不适用

Efficacy of Korean Manupuncture on Pain in Women With Endometriosis: a Parallel-group Randomized Controlled Trial

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年11月29日最近更新:
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
74
试验地点
1
主要终点
Variation in the Visual Analog Scale (VAS)

研究概览

简要总结

Endometriosis is defined as the presence and development of hormone-dependent endometrial tissue comprising both glands and stroma outside the endometrium and myometrium.

It affects 10-15% of women of childbearing age; of these, 25% are diagnosed following a consultation for infertility, and 25% following a consultation for pelvic pain.

This disease has a strong functional (pain and infertility) and organic impact, its numerous symptoms can have a considerable effect on quality of life.

Individualized analgesic management with multidisciplinary care (medical, surgical and psychological) can improve quality of life for women with endometriosis, but current treatment remains insufficient.

Korean manupuncture is a complementary treatment technique that does not interact with current treatments. It's a holistic discipline that draws up a highly detailed map of the body's correspondence on the hand. Each body zone corresponds to a zone on the hand.

The aim of this research is to evaluate the effect of Korean manupuncture on endometriosis-related pain.

Patients will be randomly assigned to 2 groups, 30 to the "Korean manupuncture" group and 30 to the "placebo/control" group. Patients will be blinded to their assigned group.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Person having given oral consent
  • Woman of legal age
  • Woman diagnosed with endometriosis consulting for pain management

排除标准

  • Not affiliated to the national health insurance system
  • Person under legal protection (curatorship, guardianship)
  • Person under court order
  • Pregnant or breast-feeding women
  • Menopausal women (menopause is defined as amenorrhea lasting more than 12 consecutive months)
  • An adult unable to give consent
  • Women who have had a hysterectomy
  • Women who cannot speak or read French
  • Hands not accessible for treatment
  • Inability to follow the entire protocol
  • Cognitive impairment

研究组 & 干预措施

Placebo/control

Placebo Comparator

干预措施: Placebo session (Other)

Korean manupuncture

Experimental

干预措施: Korean manupuncture (Other)

结局指标

主要结局

Variation in the Visual Analog Scale (VAS)

时间窗: Between Day 1 and Day 29

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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