Pelvic Girdle PainPPGPNCT05382845
Screening for Pregnancy Related Pelvic Girdle Pain
A study testing Manual pain provocation tests in people with Pelvic Girdle Pain, run by Blekinge County Council Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- Manual pain provocation tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.
Who cannot join
- Fibromyalgia
- sick-leave
- working at home
- treatment of the pelvic joints during the pregnancy
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
The Region Hospital of Blekinge County
Karlskrona, Blekinge County, SE-371 81
Bodil Ehn, MD, +46734471163, bodil.ehn@regionblekinge.se
About this study
Official title: Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of 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.
Read the 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.
- Conditions
- Pelvic Girdle Pain
- Being tested
- Manual pain provocation tests
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual pain provocation testsDiagnostic test
Also called Questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women without symptoms of pregnancy related pelvic girdle pain | Other | 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. Receives: Diagnostic Test: Manual pain provocation tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately six months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 May 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blekinge County Council Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Principal investigator, Titti (Stina) Lilje, Blekinge County Council Hospital
- Investigators
- Stina Lilje, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382845
- Sponsor's protocol ID
- BlekingCCH
- Acronym
- PPGP
- Status last verified
- Oct 2024
- First submitted
- 23 Mar 2022
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that other researchers may want to look at.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are There Associations Between the Outcomes of Pain Provocation Tests Early in Pregnancy and the Development of Pregnancy Related Pelvic Girdle Pain?
- ClinicalTrials.gov ID
- NCT05382845
- Acronym / sponsor ID
- PPGP / BlekingCCH
- Conditions
- Pelvic Girdle Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Blekinge County Council HospitalUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pregnant women without symptoms of pregnancy related pelvic girdle pain | Other | Diagnostic Test: Manual pain provocation testsThere is only one arm in this study. The intervention consists of tests to rule out ongoing pelvic pain, manual pain provocation tests, and questionnaire. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints.
Key exclusion criteria (4 listed)
- Fibromyalgia
- sick-leave
- working at home
- treatment of the pelvic joints during the pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual pain provocation testsAlso: QuestionnaireValidated 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. | Diagnostic test | Pregnant women without symptoms of pregnancy related pelvic girdle pain |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: Yes. All data that other researchers may want to look at.
Related trials for Pelvic Girdle Pain
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Symphysis Pubis Dysfunction, Pregnancy
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Effects of MET With and Without Lumbopelvic Manipulation
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Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stina Lilje, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual pain provocation tests in people with Pelvic Girdle Pain, run by Blekinge County Council Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stina Lilje, PhD (+46708233332, stina.lilje@ki.se; titti.lilje@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between pain provocation tests, different risk factors and full time sick-leave. (time frame: Approximately six months for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.