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PPGP: Screening for Pregnancy Related Pelvic Girdle Pain

Sponsor
Blekinge County Council Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05382845
Collaborator
Lund University (Other)
250
Enrollment
1
Location
1
Arm
14
Anticipated Duration (Months)
17.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Manual pain provocation tests
 N/A

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
Anticipated Enrollment :
250 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Screening
Official Title:
Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?
Actual Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Diagnostic Test: 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.
Other Names:
  • Questionnaire

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Region Hospital of Blekinge County Karlskrona Blekinge Sweden SE-371 81

    Sponsors and Collaborators

    • Blekinge County Council Hospital
    • Lund University

    Investigators

    • Principal Investigator: Stina Lilje, PhD, Karolinska Institutet

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stina Lilje, Principal Investigator, Blekinge County Council Hospital
    ClinicalTrials.gov Identifier:
    NCT05382845
    Other Study ID Numbers:
    • BlekingCCH
    First Posted:
    May 19, 2022
    Last Update Posted:
    May 19, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pelvic Girdle Pain

    Study Results

    No Results Posted as of May 19, 2022