Screening for Pregnancy Related Pelvic Girdle Pain

NCT ID: NCT05382845

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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.

Conditions

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Pelvic Girdle Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Pregnant women without symptoms of pregnancy related pelvic girdle pain

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.

Group Type OTHER

Manual pain provocation tests

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Manual pain provocation tests

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Questionnaire

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Blekinge County Council Hospital

OTHER

Sponsor Role lead

Responsible Party

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Titti (Stina) Lilje

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stina Lilje, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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The Region Hospital of Blekinge County

Karlskrona, Blekinge County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Stina Lilje, PhD

Role: CONTACT

Maria Ekelin, PhD

Role: CONTACT

+46703303069

Facility Contacts

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Bodil Ehn, MD

Role: primary

+46734471163

Other Identifiers

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BlekingCCH

Identifier Type: -

Identifier Source: org_study_id

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