Acupuncture and Low Back Pain During Pregnancy
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
- 否
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)
