Acupuncture as a Treatment for Symphysiolysis Pain and Ability in Pregnant Women.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- pain improvement
研究概览
简要总结
a randomized, observer blind and placebo-controlled cross-over study in which true acupuncture (Verum)(V) was compared to "placebo" acupuncture (P).
the investigators evaluate the effect of the acupuncture on the pain and the ability of the pregnant patient.
详细描述
the investigators recruit women who diagnose with symphysiolisis by having 2 out of 3 of the follow:
- Examine for pain or sensitivity to touch on pubic symphysis joint.
- Modified Trendelenburg's test
- Active straight leg raise test The trial doctor will mark the woman's chart with a continuous number that will become her number in the trial, and she will then be referred to the acupuncturist.
Women will be randomly divided at a 1:1 ratio, according to the randomized number chart prepared by the trial's statistician. The list of random numbers will be delivered to the head of the acupuncturist team and it will be the only copy in existence aside from the one belonging to the statistician. According to that list of numbers, the head acupuncturist will instruct the acupuncturist on call as to the type of acupuncture to be performed, true (V) vs. placebo (P) on the participant . The type of acupuncture (V or P) will be recorded in the woman's chart.
The treatment will be conducted by one of the acupuncturists on staff at the integrative medical center. All the acupuncturists have many years of experience in treating pregnant women with Chinese medicine. The acupuncture will be carried out with 0.18/40mm single use needles. Point selection and numbers of points used will be determined following the evaluation of the acupuncturist according to the accepted standards of in Chinese medicine. They will not, however, deviate from the list of true acupuncture points in the list of possible true paints . Placebo acupuncture will be three to four points selected at random from the list of placebo points . The acupuncturist's evaluation in the placebo group will be the same as in the evaluation in the treatment group and the true acupuncture points selected during that time will be the ones used in case of failure and continued pain following the first (placebo) treatment, after cross over.
It should be noted that the woman's assessment and the exam will take place before the acupuncture treatment begins, whether it is the true or placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women > 18 years
- •Single embryo pregnancy in week 24-42
- •was diagnosed with symphysiolisis according to written above
- •Pain/sensitivity >5 on NRS scale in symphysis pubis area for more than two weeks
排除标准
- •Lack of proficiency in Hebrew or English
- •Pain from a different source
- •pelvic bone disease or history of severe pelvic bone injury
- •Thrombocytopenia (plt<50.000)
- •Acupuncture treatment is contraindicated
- •High risk pregnancy
结局指标
主要结局
pain improvement
时间窗: 30 minutes
improvement of 1.5 marks on the Numeric Rating Scale (NRS) ( 0-10 , 0=no pain, 10=worst pain) as describe by the patient.
次要结局
- improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire(48-72 hours)
研究者
jaffea
OBGYN resident, MD MPH
Shaare Zedek Medical Center