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临床试验/NCT01259180
NCT01259180Unknown不适用

Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis : A Preliminary Study

East West Neo Medical Center2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Chages in Visual Analogue Scale of subjective Pelvic Pain

研究概览

简要总结

The purpose of ths study is to determine the efficacy of acupuncture on chronic pelvic pain in women with endometriosis or adenomyosis.

详细描述

Chronic pelvic pain(CPP) is a common disease among women, and its prevalence ranges from 4 to 25 percent. There are various conditions associated with CPP, including gynecologic, urologic and gastointestinal problems. Endometriosis is the most common diagnosis made at the time of gynecological laparoscopy performed to evaluate CPP. Treatments of CPP with endometriosis include medical(analgesics, oral contraceptive pills, gonadotropin releasing hormone(GnRH) agonist, etc.), surgical and combined treatment. Progestins, danazol, estrogen-progestin pills, or GnRH agonists are commonly used as a concurrent treatment along with surgery. However, a systematic review on the comparison of postsurgical hormonal suppression to surgery alone concluded that, while postoperative medical therapy decreased recurrence rates, there was no significant benefit on the outcomes of pain and pregnancy rates. Therefore there is a need for postoperaive medical therapy for pain relief. In this study, the investigators propose a randomized, sham-controlled trial to investigate the efficacy of acupuncture as a pain control for the patients dignosed endometriosis during laparoscopic surgery due to CPP, and have been on 6 month-scheduled GnRH agonist treatment as a postoperative treatment.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients diagnosed pathologically of Endometriosis or Adenomyosis among those who had undergone laparoscopic surgery due to pelvic pain
  • Patients who have been on GnRH agonist treatment for 6 months after being diagnosed Endometriosis or Adenomyosis
  • Patients who agreed a written consent by their own will
  • Patients' compliance and geographical adjacency appropriate for proper follow up survey
  • continuous pelvic pain over VAS 5 during past 1 week on screening visit(after 6 weeks of surgery) (0='no pain', '10=most severe')

排除标准

  • Those who had taken hormones or drugs that can affect diagnosis of endometriosis or adenomyosis for past 1 year
  • Patients found to have malignant tumor of uterus and adenexa, PID or pregnancy during surgery
  • Allergies to metal or contraindications for acupuncture treatment (ex: coagulopathy, epilepsy)
  • Unable to participate in clinical trial by doctor's judgment
  • irritable bowel syndrome

结局指标

主要结局

Chages in Visual Analogue Scale of subjective Pelvic Pain

时间窗: 7wks

次要结局

  • Health-related Quality of Life(7wks)

研究者

发起方
East West Neo Medical Center
申办方类型
Other

研究点 (2)

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