Screening for Pregnancy Related Pelvic Girdle Pain (PPGP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Girdle Pain
• Intervention / Treatment: Diagnostic test: Manual pain provocation tests

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stina Lilje, PhD; Phone Number: +46708233332; Email: stina.lilje@ki.se; titti.lilje@gmail.com
• Study Contact Backup: Name: Maria Ekelin, PhD; Phone Number: +46703303069; Email: maria.ekelin@med.lu.se

Study Locations

• Sweden
  • Blekinge
    • Karlskrona, Blekinge, Sweden, SE-371 81
      • Recruiting
      • The Region Hospital of Blekinge County
      • Contact: Bodil Ehn, MD; Phone Number: +46734471163; Email: bodil.ehn@regionblekinge.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Blekinge County Council Hospital
• Collaborators: Lund University
• Investigators: Principal Investigator: Stina Lilje, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 20, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Pelvic Girdle Pain
• Other Study ID Numbers: BlekingCCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data that other researchers may want to look at.
• IPD Sharing Time Frame: 6 months after publication
• IPD Sharing Access Criteria: Upon reasonable request
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No