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NCT Number: NCT05382845

Screening for 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.

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Key information

Conditions

Pelvic Girdle Pain Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Region Hospital of Blekinge County

Karlskrona, Blekinge County, SE-371 81, Sweden

Location status: Recruiting

Location contact

Bodil Ehn, MD

CONTACT

[email protected]

+46734471163

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual pain provocation tests

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.

Other names: Questionnaire

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Ekelin, PhD

CONTACT

[email protected]

+46703303069

Stina Lilje, PhD

CONTACT

[email protected]; [email protected]

+46708233332

Sponsors and collaborators

Lead sponsor

Blekinge County Council Hospital

Other

Collaborators

  • Lund University

Registry information

Official study title

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

Acronym: PPGP

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 19, 2022
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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