NCT06785909 Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain.
| NCT ID | NCT06785909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hasselt University |
| Condition | Low Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 211 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2028-09-01 |
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 211 participants in total. It began in 2025-03-03 with a primary completion date of 2028-09-01.
⚠ 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
Pregnancy-related lumbopelvic pain (PLPP) affects 50-90% of pregnant women and is often dismissed as a normal part of pregnancy. However, the long-term consequences can be dramatic. Up to 21% of women with PLPP still have pain three years postpartum, and 10% experience disability, poorer quality of life, and lower ability to work 11 years after delivery. Because the multifactorial etiology of PLPP is unclear, prevention and treatment fall short. Previous studies on the causes of PLPP focused on impairments in motor output but ignored that impairments in sensory input (e.g., proprioception, the primary expertise of our research group) often precede motor output problems. Moreover, though psychological factors such as fear (of movement) are known to affect PLPP, their predictive role in PLPP remains understudied. Finally, the role of systemic inflammation in PLPP has yet to be examined, despite recent studies demonstrating its role in the chronification of lumbopelvic pain in the general population. This prospective cohort study aims to identify new modifiable predictors for the onset of PLPP during pregnancy and its persistence postpartum. The investigators will compare sensory (proprioception, body perception), fear-related, and inflammatory factors between women with and without PLPP and determine their predictive role in the onset and persistence of PLPP. The results will increase our understanding of the multifactorial etiology of PLPP and help optimize prevention and treatment.
Eligibility Criteria
Inclusion Criteria: * Informed consent to participate * 18-40 years old * Pregnant * Singleton pregnancy (confirmed through ultrasound) * No current PLPP * Dutch- or English-speaking Exclusion Criteria: * Pregnant for more than 16 weeks * Currently experiencing PLPP, or having had PLPP during the index pregnancy * History of surgery or major trauma to the spine or pelvis, major trauma or surgery to the lower limbs more than 2 years ago with current residual symptoms (e.g., pain, instability, stiffness), major trauma or surgery to the lower limbs less than 2 years ago * Specific vestibular or balance disorders * Use of medication that could affect balance (e.g., ototoxic or centrally-acting drugs) * Having a medical diagnosis for, being treated by a rheumatologist for, or taking medication for a rheumatic condition * (History of) a neurological disorder (e.g., neuropathy) * Problems with vision that are not corrected by glasses, contact lenses or surgical eye correction * Recent history of ankle problem (e.g., ankle sprain less than 3 weeks ago) * Being on absolute/relative bed rest due to pregnancy complications * (History of) inflammatory (e.g., gout, endometriosis), (auto)immune (e.g., lupus, ankylosis spondylitis, rheumatoid arthritis, psoriasis, Crohn's disease, Graves' disease, Hashimoto's thyroiditis, colitis ulcerosa, multiple sclerosis, etc.), hypothyroidism, or cancer. * Having (had) a formal diagnosis of a psychiatric disorder (e.g., psychotic disorder).
Contact & Investigator
Lotte Janssens, Prof, PhD, PT
PRINCIPAL INVESTIGATOR
Hasselt University
Frequently Asked Questions
Who can join the NCT06785909 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Low Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06785909 currently recruiting?
Yes, NCT06785909 is actively recruiting participants. Contact the research team at lotte.janssens@uhasselt.be for enrollment information.
Where is the NCT06785909 trial being conducted?
This trial is being conducted at Hasselt, Belgium, Leuven, Belgium.
Who is sponsoring the NCT06785909 clinical trial?
NCT06785909 is sponsored by Hasselt University. The principal investigator is Lotte Janssens, Prof, PhD, PT at Hasselt University. The trial plans to enroll 211 participants.