NCT04226716 The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain
| NCT ID | NCT04226716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hasselt University |
| Condition | Pelvic Girdle Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 192 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 192 participants in total. It began in 2020-06-01 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine, psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) and increased serum concentrations of specific inflammatory mediators are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.
Eligibility Criteria
Inclusion Criteria Multiparous Women: * Singleton pregnancy * Pregnant of second child or more than second child * No current PPGP or did not have PPGP during current pregnancy * Willing to provide written informed consent Exclusion Criteria Multiparous Women: * Pregnant for more than 16 weeks * Having current PPGP or having had PPGP during the current pregnancy * History of surgery/major trauma to spine or pelvis * Surgery/physical trauma to the lower limbs more than two years ago and currently still experiencing symptoms such as pain, instability, or stiffness * Surgery/physical trauma to the lower limbs less than two years ago * Specific balance or vestibular disorders * A medical diagnosis of a rheumatic condition or being under treatment for such a condition by a rheumatologist * Neurological abnormalities (e.g., peripheral neuropathy) * Uncorrected visual problems * Acute ankle problems * Being on absolute or relative bed rest due to pregnancy-related complications * Having (had) a formal diagnosis of a psychiatric disorder * Non-Dutch speaking Inclusion Criteria Nulliparous Women: * Age- and BMI- matched to pregnant participants * Nulliparous * Willing to provide written informed consent Exclusion Criteria Nulliparous Women: * Having low back or pelvic girdle pain at the time of inclusion or in the six months leading up to inclusion * History of chronic low back or pelvic girdle pain * History of surgery/major trauma to spine, pelvis and/or lower limbs, * Specific balance or vestibular disorders * Spinal deformities * Rheumatic disease * Neurological abnormalities * Acute ankle problems * (A history of) psychiatric disorders * Uncorrected visual problems * Non-Dutch speaking
Contact & Investigator
Lotte Janssens, PhD, PT
PRINCIPAL INVESTIGATOR
Hasselt University
Frequently Asked Questions
Who can join the NCT04226716 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Pelvic Girdle Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04226716 currently recruiting?
Yes, NCT04226716 is actively recruiting participants. Contact the research team at nina.goossens@uhasselt.be for enrollment information.
Where is the NCT04226716 trial being conducted?
This trial is being conducted at Hasselt, Belgium.
Who is sponsoring the NCT04226716 clinical trial?
NCT04226716 is sponsored by Hasselt University. The principal investigator is Lotte Janssens, PhD, PT at Hasselt University. The trial plans to enroll 192 participants.