Screening for Pregnancy Related Pelvic Girdle Pain (PPGP)
Primary Purpose
Pelvic Girdle Pain
Status
Active
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Manual pain provocation tests
Sponsored by
About this trial
This is an interventional screening trial for Pelvic Girdle Pain
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
Sites / Locations
- The Region Hospital of Blekinge County
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pregnant women without symptoms of pregnancy related pelvic girdle pain
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05382845
First Posted
March 23, 2022
Last Updated
July 26, 2023
Sponsor
Blekinge County Council Hospital
Collaborators
Lund University
1. Study Identification
Unique Protocol Identification Number
NCT05382845
Brief Title
Screening for Pregnancy Related Pelvic Girdle Pain
Acronym
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?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Blekinge County Council Hospital
Collaborators
Lund University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prediction modelling, where risk factors such as earlier trauma to the pelvis, earlier low back pain, earlier pregnancy related pelvic girdle pain, physically demanding job, contraception and the outcomes of the pain provocation tests will predict to what degree a woman is at risk of developing symptoms.
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women without symptoms of pregnancy related pelvic girdle pain
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Manual pain provocation tests
Other Intervention Name(s)
Questionnaire
Intervention Description
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 Measure Information:
Title
Correlation between pain provocation tests, different risk factors and full time sick-leave.
Description
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.
Time Frame
Approximately six months for each participant
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
It is still not possible for other than women to become pregnant.
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stina Lilje, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Region Hospital of Blekinge County
City
Karlskrona
State/Province
Blekinge
ZIP/Postal Code
SE-371 81
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Screening for Pregnancy Related Pelvic Girdle Pain
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