Trial of Acupuncture Pelvic and Low Back Pain in Pregnancy (TAPPP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number and % of days during pregnancy with maximum pain ≤ 4/10.
研究概览
简要总结
Pelvic girdle and low back pain are common in pregnancy, and cause severe impairment in 10% of women. Our hypothesis is that offering acupuncture in addition to standard care would reduce pain and impairment throughout pregnancy. 300 pregnant women from 5 maternity units will be randomized over a 3 year period to receive standard care or standard care plus acupuncture. Main outcome will be the number of days during pregnancy with maximum pain ≤ 4/10. Secondary outcomes will compare groups for an impairment score and for direct and indirect costs.
详细描述
Background. Pelvic and low back pain (PLBP) affects 30% of pregnant women for weeks or months, causing severe impairment in 10% of women. Standard treatment, based on pain killers, postural recommendations, exercises, is of limited value. Previous trials showed that adding acupuncture to standard treatment reduces pain and impairment in the short run.
Hypothesis Providing acupuncture to pregnant women with PLBP could reduce pain and impairment throughout pregnancy, thus reducing other direct and indirect cots related to PLBP.
Primary Outcome. Number and % of days during pregnancy with maximum pain ≤ 4/10.
Secondary Outcomes. Pain scale 4 weeks after inclusion, mean Oswestry disability score between inclusion and delivery, direct costs related to pregnancy care and pain management, indirect costs related to impairment throughout pregnancy and the immediate postpartum.
Method. Multicenter randomized trial with parallel groups. Intervention: 5 acupuncture sessions over 4 weeks, plus standard treatment. Controls: standard 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton uncomplicated 16-34 weeks pregnancy, with PLBP > 4/10
排除标准
- •Obstetrical complication other than PLBP,
- •contra indication to acupuncture,
- •maternal age < 18
- •no health insurance.
研究组 & 干预措施
acupuncture
5 acupuncture sessions over a 4 week period plus standard treatment
干预措施: acupuncture (Other)
usual care
standard treatment (pregnancy belt, behavioral recommendations, exercises, pain killers as prescribed by usual health care professional)
干预措施: usual care (Other)
结局指标
主要结局
Number and % of days during pregnancy with maximum pain ≤ 4/10.
时间窗: at 4 weeks
daily recording on logbook (self assessment)
次要结局
- Mean Oswestry disability score(during pregnancy)
- Number and % of days with maximum pain ≤ 4/10.(during pregnancy)
- direct and indirect costs(during pregnancy)