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Recruiting NCT05382845

Screening for Pregnancy Related Pelvic Girdle Pain

No phase Interventional Pelvic Girdle Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Manual pain provocation tests.
Who it may be relevant to
Registry conditions: Pelvic Girdle Pain. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of 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.

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.

Primary outcome measures

  • Correlation between pain provocation tests, different risk factors and full time sick-leave. [Time frame: Approximately six months for each participant]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Sweden · 1 center
  • The Region Hospital of Blekinge County — Karlskrona

Identifiers

NCT: NCT05382845 · BlekingCCH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗