The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related P… (NCT04226716) | Clinical Trial Compass
RecruitingNot Applicable
The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain
Belgium192 participantsStarted 2020-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,
* Specif…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)