Screening for Pregnancy Related Pelvic Girdle Pain

Overview

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.

Full Title of Study: “Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 30, 2023

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

It is still not possible for other than women to become pregnant.

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Blekinge County Council Hospital
  • Collaborator
    • Lund University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Stina Lilje, Principal Investigator – Blekinge County Council Hospital
  • Overall Official(s)
    • Stina Lilje, PhD, Principal Investigator, Karolinska Institutet

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