Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 360
- Locations
- 2
- Primary Endpoint
- Correlation between pain provocation tests, different risk factors and full time sick-leave.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.
Exclusion Criteria
- •Fibromyalgia
- •sick-leave
- •working at home
- •treatment of the pelvic joints during the pregnancy
Outcomes
Primary Outcomes
Correlation between pain provocation tests, different risk factors and full time sick-leave.
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Titti (Stina) Lilje
Principal Investigator
Blekinge County Council Hospital