Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorHasselt University
About this trial
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
This trial does not accept healthy volunteersQualifiers
Informed consent to participate
18-40 years old
Pregnant
Singleton pregnancy (confirmed through ultrasound)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Assessment of postural control, body perception, psychosocial factors and inflammation
BehavioralBehavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception, psychosocial factors (incl. fear of movement, pain catastrophizing, sense of coherence, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress) and inflammatory mediators.
Treatment groups
211 Participants
are divided into 1 treatment groupGroup A: Primiparous pregnant womenOther 1 intervention
Trial outcomes
Primary outcomes
1
Pregnancy-related lumbopelvic pain (PLPP) (pregnant women)
The presence of PLPP will be questioned at each timepoint. PLPP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, articularly in the vicinity of the sacroiliac joints, that may radiate to the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis."
Time frame
Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)2
Postural control (pregnant women)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame
Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)3
Proprioceptive use during postural control (pregnant women)
Center-of-pressure displacements in response to ankle muscle and lower back muscle vibration (60 Hz, 15s) during upright standing will be measured with a force plate.
Time frame
Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)4
Inflammation with blood samples (pregnant women)
Serum concentrations of inflammatory mediators will be measured.
Time frame
Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)Secondary outcomes
1
Disability due to PLPP with the Modified Oswestry Disability Index (mODI) (pregnant women)
The ODI is a 10-item self-report questionnaire that quantifies the extent of functional limitation in daily life due to low back pain. Each item is given a score between 0 (no limitation) and 5 (maximal limitation). The sum of the scores is multiplied by 2 to obtain a percentage score, with higher scores representing greater functional disability
Time frame
Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)2
Disability due to PLPP with the Quebec Back Pain Disability Scale (QBPDS) (pregnant women)
The QBPDS assesses disability in individuals with low back pain and PLPP: 20 items, total score range 0 - 100. Higher scores indicate higher levels of disability.
Time frame
Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)3
Pain intensity of PLPP with Visual Analogue Scale (VAS) (pregnant women)
The participants will be asked to rate the pain intensity at the lower back or pelvic girdle they experience at this moment (i.e., both at the start and the end of the full test procedure), the average pain intensity during the past week, the minimal pain intensity during the past week, and the maximal pain intensity during the past week, by using the Visual Analogue Scale (VAS, 0-100), with 0 = "no pain" and 100 = "the worst pain imaginable".
Time frame
Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)4
Pain frequency of PLPP (pregnant women)
The participants will be asked how often they experience pain (1= some days, 2= most days, 3= every day)
Time frame
Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)Other outcomes
1
Diagnostic clinical tests for PLPP (pregnant women)
In case the participant indicates pain in (one of) the PLPP regions (first criterium), the following clinical tests will be performed (second criterium) to confirm the presence of PLPP: thigh thrust, modified Trendelenburg test, Active straight leg raise test (ASLR). The participant will perform the ASLR test in supine lying: she will be asked to lift one leg 20 cm off the bed, and a score between 0 and 5 will be assigned depending on the difficulty experienced (0= "not difficult at all, 1= minimally difficult, 2= somewhat difficult, 3 = fairly difficult, 4= very difficult, 5= unable to do).
Time frame
Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)2
Sociodemographic information: age (pregnant women)
The age of the participant will be noted (in years and months)
Time frame
Timepoint 1 (between gestational weeks 9-16)3
Sociodemographic information: annual household income (pregnant women)
The participant will be asked: How would you describe your ability to make ends meet, considering your income and expenses?: With great difficulty, with difficulty, with some difficulty, fairly easily, easily, very easily
Time frame
Timepoint 1 (between gestational weeks 9-16)4
Sociodemographic information: marital status (pregnant women)
Marital status will be questioned (having a partner or not, living together/alone)
Time frame
Timepoint 1 (between gestational weeks 9-16)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hasselt University
Lead sponsor
KU Leuven
Collaborator
Source ClinicalTrials.gov