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临床试验/NCT05382845
NCT05382845招募中不适用

Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?

Blekinge County Council Hospital2 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
360
试验地点
2
主要终点
Correlation between pain provocation tests, different risk factors and full time sick-leave.

研究概览

简要总结

To perform clinical manual pain provocation tests of the pelvic joints in pain free pregnant women early in pregnancy, follow them until delivery, and compare those who develop PPGP with those who don't.

详细描述

One arm study:

Pregnant women are informed about the study at their first visit in Maternity care. Those that are interested in participating sign an informed consent, and book an appointment with a manual therapist. During the appointment five pain provocation tests are performed to the pelvic joints, and about 13 questions regarding previous low back pain, trauma to the pelvic, or pelvic pain during previous pregnancies, number of previous pregnancies, number of years with contraception, any presence of lactosis intolerance, profession, degree of physical exercises, gestational week, age, and BMI are asked by the therapist. Each participant is given a telephone call after delivery, to ask whether any pelvic pain ocurred or not, and whether sick-leave was necessary.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.

排除标准

  • Fibromyalgia
  • sick-leave
  • working at home
  • treatment of the pelvic joints during the pregnancy

结局指标

主要结局

Correlation between pain provocation tests, different risk factors and full time sick-leave.

时间窗: Approximately six months for each participant

Screening of symptom free pregnant women at their first visit in Maternity care using pain provocation tests of the pelvic joints, together with known risk factors for Pregnancy related Pelvic Girdle Pain (PPGP), and a plausible association with the primary outcome full time sick-leave due to PPGP.

次要结局

未报告次要终点

研究者

发起方
Blekinge County Council Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Titti (Stina) Lilje

Principal Investigator

Blekinge County Council Hospital

研究点 (2)

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