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NCT05382845 Clinical Trial

Screening for Pregnancy Related Pelvic Girdle Pain

Pelvic Girdle Pain Clinical Trial

— PPGP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05382845
Other study ID # BlekingCCH
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date October 30, 2023

Study information
Verified date July 2023
Source Blekinge County Council Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 250
Est. completion date October 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Sweden The Region Hospital of Blekinge County Karlskrona Blekinge

Sponsors (2)
Lead Sponsor Collaborator
Blekinge County Council Hospital Lund University

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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