Screening for Pregnancy Related Pelvic Girdle Pain

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.

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

Conditions
-----------------
Pelvic Girdle Pain

Intervention / Treatment
-----------------
* Diagnostic Test: Manual pain provocation tests


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Prediction modelling, where risk factors such as earlier trauma to the pelvis, earlier low back pain, earlier pregnancy related pelvic girdle pain, physically demanding job, contraception and the outcomes of the pain provocation tests will predict to what degree a woman is at risk of developing symptoms.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pregnant women without symptoms of pregnancy related pelvic girdle pain<br>There is only one arm in this study. The intervention consists of tests to rule out ongoing pelvic pain, manual pain provocation tests, and questionnaire. | Diagnostic Test: Manual pain provocation tests<br>* Validated and empirical pain provocation tests of the pelvic joints will be performed, both to exclude ongoing symptoms, and to diagnose one or several dysfunctions. The participants will be asked questions regarding previous symptoms, traumas, type of profession etc.<br>* Other names: Questionnaire;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between pain provocation tests, different risk factors and full time sick-leave. | 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. | Approximately six months for each participant |