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临床试验/NCT00571480
NCT00571480已完成不适用

Acupuncture and Low Back Pain During Pregnancy

Yale University2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2005年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
159
试验地点
2
主要终点
severity pain

研究概览

简要总结

Ear acupuncture can be used as a treatment for pregnancy induced low back pain.

详细描述

Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 & 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 46 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy.
  • No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention.

排除标准

  • Non-English speaking
  • Mentally challenged
  • State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain
  • Pregnant women without low back pain
  • The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.

结局指标

主要结局

severity pain

时间窗: two weeks

次要结局

  • daily disability index(2 weeks)

研究者

申办方类型
Other

研究点 (2)

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