Investigating factors affecting pregnancy-related lumbopelvic pain
The Role of Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain in Pregnant Women.
NA · Hasselt University · NCT06785909
This study is trying to find out what causes pregnancy-related back and pelvic pain in women during their third trimester and after giving birth by looking at physical and emotional factors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 211 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Hasselt University (other) |
| Locations | 2 sites (Hasselt and 1 other locations) |
| Trial ID | NCT06785909 on ClinicalTrials.gov |
What this trial studies
This study explores the multifactorial causes of pregnancy-related lumbopelvic pain (PLPP) by examining proprioceptive, fear-related, and inflammatory factors in women during their third trimester and postpartum. It aims to identify differences in sensory input, psychological factors, and inflammatory markers between women with and without PLPP. The study will assess these factors over time to understand their correlation and impact on pain persistence. By focusing on both physical and psychological aspects, the research seeks to provide a comprehensive understanding of PLPP.
Who should consider this trial
Good fit: Ideal candidates are first-time pregnant women aged 18-40 who are currently not experiencing lumbopelvic pain.
Not a fit: Patients who are currently experiencing lumbopelvic pain or have a history of it during their pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention and treatment strategies for pregnancy-related lumbopelvic pain, enhancing the quality of life for affected women.
How similar studies have performed: While the study addresses a common issue, the specific combination of proprioceptive, psychological, and inflammatory factors in PLPP is relatively novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Hasselt and 1 other locations
- Hasselt University — Hasselt, Belgium (RECRUITING)
- KU Leuven — Leuven, Belgium (RECRUITING)
Study contacts
- Principal investigator: Lotte Janssens, Prof, PhD, PT — Hasselt University
- Study coordinator: Lotte Janssens, Prof, PhD
- Email: lotte.janssens@uhasselt.be
- Phone: +32 474 43 56 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Low Back Pain, Lumbopelvic Pain, Pelvic Girdle Pain, postural control, body perception, psychological factors, inflammation