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Pelvic Girdle PainNCT05507853

Exploring Central Sensitization in Pregnant Women

An observational study of Pelvic Girdle Pain and Chronic Pain, run by Göteborg University at 1 site in Sweden.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Pelvic Girdle Pain (PGP) is reported by 50% of pregnant women and up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP. Central (nervous system) sensitization that elicits pain hypersensitivity, may be one explanation. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pelvic Girdle Pain, Chronic Pain
How many people
144 participants
Where
1 siteSweden
Study dates
15 Aug 2023to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: pregnant women at maternity care units and social media

Who may be able to join

  • pregnant (first time pregnant or previous experience of pregnancy)
  • 18 years of age or older
  • have a single foetus pregnancy
  • be in gestational weeks 20-30
  • able to read and understand Swedish or English

Who cannot join

  • no history of a fracture or malignant disease in the back, pelvis, pelvic floor or hips
  • no systemic disease of the musculoskeletal or the nervous system
  • no diseases such as gestational diabetes or diabetes type 1 and 2, hypertension
  • no obstetric complications
  • no contradiction for tests.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Annelie Gutke, associate professor contact

0046(0)7665747

annelie.gutke@gu.se

Sonia Coelho Cristovao, PhD-student contact

Sweden1 site, 1 recruiting

  • Närhälsan Gibraltargatan

    Gothenburg, 43654

    Annelie Gutke, 0766-185747, annelie.gutke@gu.se

    Recruiting

Other trials in Sweden

About this study

Official title: In the Joints or in the Brain? Exploring Central Sensitization in Pregnant Women and Its Role in Pain, Physical Activity, Functioning and Health Following Pregnancy

Pelvic Girdle Pain (PGP) is reported by 50% of pregnant women and up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP. Central (nervous system) sensitization that elicits pain hypersensitivity, may be one explanation.

The overall aim of this study is to explore features of central sensitization in pregnant women and its predictive ability on physical activity, functioning and health in women with PGP. Measurements of central sensitization will be done on two study groups, pregnant women with PGP and healthy controls. To identify women at risk to develop chronic pain in relation to a common pain experience ie PGP in pregnancy, may help us understand if central sensitization early in life explains why women develop chronic pain.

Read the detailed description

Pelvic Girdle Pain (PGP) is reported by 50% (60000) of pregnant women yearly in Sweden. PGP is expected to disappear after delivery. However up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP with large impact on their physical activity, functioning,and health. Central (nervous system) sensitization, defined as an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity, may be one explanation why 10% of women develop postpartum chronic PGP and related physical inactivity.

The overall aim of this study is to explore features of central sensitization in pregnant women and its predictive ability on physical activity, functioning and health in women with PGP. Two study groups, pregnant women with PGP and healthy controls (including non-native Swedish) will be included through maternity care units and a blog. Measurements of primary outcome central sensitization will be done. To identify women at risk to develop chronic pain in relation to a common pain experience ie PGP in pregnancy, may help us understand if central sensitization early in life explains why women develop chronic pain.

Medical subject headings
Pelvic Girdle Pain, Chronic Pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. central sensitization measured by Patient Pain Drawing

    spreading of pain

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  2. central sensitization measured by conditioned pain modulation using an algometer and a occlusion cuff

    Malfunctioning of descending nociceptive inhibitory pathways resulting in dysfunctional endogenous analgesia, assessed by a conditioned pain modulation (CPM)=

    1. PressurePainThresholds (PPT)is assed by a digital algometer at symtomatic (sacrum and lumbar paravertebral muscles and 2 remote locations)+at asymptomatic regions(web thumb-index, prox 1/3 calf )
    2. mechanism of CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the participant's left arm to a painful intensity. The occlusion cuff is inflated until 'the first sensation of pain' is reported. This cuff inflation is maintained for 30 sec. The participant is than asked to rate the pain intensity, as a result of cuff inflation at the left arm, on a NRS (0=no pain-10=worst pain). Next, the cuff inflation is increased or decreased until pain intensity at the left arm was rated as 3/10 on NRS. The PPT assessments are then repeated during maintenance of the cuff inflation and relaxation of the left arm.

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

Secondary outcomes (8)

  1. Pregnancy Physical Activity Questionnaire

    Physical activity and exercise are measured by this self-administered questionnaire which provides assessment of four domains of physical activity; ''Sports and Exercises', ''Household and Caregiving'', 'Transportation''and ''Occupation'. Since it measures the frequency and the duration of the activities, (an intensity value assigned to each activity), the minimum values are 0 but here are no maximum values. The activities can be analyzed by type, by intensity or for the total energy expenditure.

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  2. Pelvic Girdle Questionnaire

    Functioning. Minimum score 0 maximum score 100 where high scores mean worse outcome.

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  3. Patients Specific Functioning Scale

    Two by the participant, self-chosen activities rated on a numeric rating scale. Minimum score 0 maximum score 10 where high scores mean better outcome

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  4. EuroQol 5-dimension questionnaire (EQ5D)

    Health-related quality of life. Minimum score -0,59 and 1 maximum score where high scores mean better outcome

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  5. Work Ability Index

    Current work ability marked on a Numeric Rating Scale. Minimum score 0 maximum score 10 where high scores mean better outcome

    Measured: change from baseline (gestational week 20-30),at 12 months after delivery,

  6. Numeric Rating Scale for pain

    pain intensity. Minimum score 0 maximum score 10 where high scores mean worse outcome

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  7. Numeric Rating Scale for concern

    Concern. Minimum score 0 maximum score 10 where high scores mean worse outcome

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

  8. Edinburgh Postnatal Depression Scale

    Symptoms of depression. Minimum score 0 maximum score 30 where high scores mean worse outcome

    Measured: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start15 Aug 2023
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507853
Sponsor's protocol ID
VGFOUREG-939632
Status last verified
Mar 2025
First submitted
31 May 2022
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Girdle Pain and Chronic Pain, run by Göteborg University 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Annelie Gutke, associate professor (0046(0)7665747, annelie.gutke@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

central sensitization measured by Patient Pain Drawing (time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05507853.

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 1 Apr 2025.

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