Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain. (PROFit)

The Role of Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain in Pregnant Women.

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.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain; Pelvic Girdle Pain; Lumbopelvic Pain
• Intervention / Treatment: Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation

Detailed Description

This study comprises a prospective cohort study with three objectives.

Objective 1 is to investigate whether the reliance on lumbar versus ankle proprioception during standing and body perception at the lower back (i.e., "proprioceptive factors"), anxiety, fear of movement, pain catastrophizing, depression, stress, and coping with stressful situations (i.e. "fear-related factors"), and inflammatory markers (i.e., "inflammatory factors") change over time and differ between women with and without PLPP in the 3rd pregnancy trimester, 6 weeks postpartum, and 9 months postpartum. We hypothesize that women with PLPP show (1a) a maladaptive reliance on ankle proprioception and/or disturbed body perception at the lower back, (1b) higher levels of fear of movement, anxiety, stress, depression, pain catastrophizing and poorer coping with stress, and (1c) greater immune activation and a disturbed balance of pro- vs. anti-inflammatory markers compared to pain-free women.

Objective 2 is to determine whether the proprioceptive, fear-related, and inflammatory factors are correlated in women with PLPP. Based on previous findings, we hypothesize that anxiety correlates with higher concentrations of IL-6 and IL-12, and lower concentrations of IL-2 and IL-10. We will also examine whether maladaptive reliance on ankle proprioception and disturbed body perception at the lower back correlate with fear of movement, anxiety, and concentrations of inflammatory markers in women with PLPP.

Objective 3 is to investigate whether the proprioceptive, fear-related, and inflammatory factors predict the presence of PLPP in the 3rd trimester, 6 weeks postpartum and 9 months postpartum. Based on previous research, we hypothesize that a maladaptive reliance on ankle proprioception and disturbed body perception at the lower back, higher levels of anxiety and fear of movement, and immune activation and disturbed balance of pro- and anti-inflammatory markers in the 1st trimester predict having PLPP in the 3rd trimester. We also expect that the presence of these factors in the 3rd trimester predicts the persistence of PLPP 6 weeks and 9 months postpartum.

• Study Type: Interventional
• Enrollment (Estimated): 211
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lotte Janssens, Prof, PhD; Phone Number: +32 474 43 56 39; Email: lotte.janssens@uhasselt.be
• Study Contact Backup: Name: Inge Geraerts, Prof, PhD; Phone Number: +32 16 32 91 20; Email: inge.geraerts@kuleuven.be

Study Locations

• Belgium
  • Hasselt, Belgium
    • Recruiting
    • Hasselt University
    • Contact: Lotte Janssens, Prof, PhD; Phone Number: 0474 43 56 39; Email: lotte.janssens@uhasselt.be
    • Principal Investigator: Lotte Janssens, Prof, PhD
  • Leuven, Belgium
    • Recruiting
    • KU Leuven
    • Contact: Inge Geraerts, Prof, PhD, PT; Phone Number: +32 16 32 91 20; Email: inge.geraerts@kuleuven.be
    • Principal Investigator: Inge Geraerts, Prof, PhD, PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Primiparous pregnant women; Pregnant women without PLPP at the time of inclusion are followed from the first pregnancy trimester until 9 months postpartum. Assessments are performed during the first and third trimester, and 6 weeks and 9 months postpartum.

Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation; Behavioral 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Postural control (pregnant women)	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
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.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Inflammation with blood samples (pregnant women)	Serum concentrations of inflammatory mediators will be measured.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Task-related fear of movement (pregnant women)	Participants will be asked whether they are reluctant to perform any movement or activity in which their lower back or pelvis is involved, because they might have some concerns. If so, they are asked to specify the concerns and describe the movements or activities. For each of the activities, they will be asked to rate their (1) pain intensity, (2) perceived harmfulness, (3) fear, and (4) self-efficacy to perform the task, all via a Visual Analogue Scale (VAS) with 0= no pain/harmfulness/fear/self-efficacy to 100= maximal pain/harmfulness/fear/self-efficacy.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (pregnant women)	The SOC-13 contains 13 items, total score ranges 0 - 91.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (pregnant women)	The DASS-21 evaluates depressive mood, anxiety and stress in general: 21 items, total score per subscale (Depression, Stress, Anxiety) range 0 - 21. Higher scores indicate higher levels of depressive mood (DASS-21-Depression), anxiety (DASS-21-Anxiety) and stress (DASS-21-Stress).	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) (pregnant women)	The PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36)
Pregnancy-related depression with the Edinburgh Depression Scale (EDS)(pregnant women)	The EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (pregnant women)	The PCS contains 13 statements on thoughts and emotions possibly related to the experience of pain, for which the participants rates her agreement: 13 items, total score range 0 - 52. Higher scores indicate higher levels of pain catastrophizing.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Body perception at the lumbar spine assessed with a laterality recognition task ("Recognise Back" app) (pregnant women)	During the laterality recognition task, participants view 40 pictures of a model that has its lower back bent or rotated to the left or the right side. They will be asked to judge the direction of movement as quickly and accurately as possible. Average speed (in seconds) of response time and average accuracy of the answers (in %) will be recorded.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Body perception at the lumbar spine assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (pregnant women)	The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
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.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
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".	Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
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)	Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (pregnant women)	The SF-36 evaluates health-related quality of life, 8 scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores for the different scales are converted and pooled using a scoring key, for a total score ranging 0 - 100	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (pregnant women)	The FABQ consists of 16 statements for which the participant rates her agreement with the statement on a scale from 0 ("completely disagree") to 6 ("completely agree"): 16 items, total score range 0 - 96). Higher scores on the FABQ indicated more strongly held fear-avoidance beliefs.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pain location of PLPP with a body chart (pregnant women)	Individuals with PLPP will indicate the pain locations on a body chart.	Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Current body weight (pregnant women)	Current body weight will be measured (kg)	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Current fat mass (in kg) and fat-free mass (in kg) (pregnant women)	Current fat mass and fat-free mass (in kg) will be measured using bioelectrical impedance analysis (Bodystat 1500, EuroMedix).	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), and Timepoint 4 (9 months postpartum)
Current total body water (in liter) (pregnant women)	Current total body water (in liter) will be measured using bioelectrical impedance analysis (Bodystat 1500, EuroMedix).	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), and Timepoint 4 (9 months postpartum)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Sociodemographic information: age (pregnant women)	The age of the participant will be noted (in years and months)	Timepoint 1 (between gestational weeks 9-16)
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	Timepoint 1 (between gestational weeks 9-16)
Sociodemographic information: marital status (pregnant women)	Marital status will be questioned (having a partner or not, living together/alone)	Timepoint 1 (between gestational weeks 9-16)
Sociodemographic information: educational level (pregnant women)	Highest obtained educational level will be recorded (i.e., primary education, secondary education, higher education (e.g., bachelor, master, PhD), currently in secondary education, currently in higher education)	Timepoint 1 (between gestational weeks 9-16)
Sociodemographic information: current employment status (pregnant women)	Current job status will be recorded (i.e., paid full-time job, paid part-time job, in sick leave because of issues related to pregnancy but not due to PLPP, in sick leave because of PLPP, in sick leave for reasons not related to pregnancy or PLPP, paid job but currently on career break (e.g., pregnancy or maternity leave), unemployed, no paid job but unpaid volunteer work, student), and type of work (i.e., sedentary, manual work, heavy manual work)	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Number of previous miscarriages (pregnant women)	The number of previous miscarriages will be recorded.	Timepoint 1 (between gestational weeks 9-16)
Smoking habits (pregnant women)	Smoking habits, including tobacco and vaping (i.e., daily, occasional, former, non-smoker) and number of cigarettes per day will be questioned.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Alcohol consumption (pregnant women)	Alcohol consumption (i.e., lifetime abstainer, former infrequent drinker, former regular drinker, current infrequent drinker, current light drinker, current moderate drinker, current heavier drinker) will be questioned.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Physical activity with IPAQ-SF (pregnant women)	Score on the International Physical Activity Questionnaire short form (IPAQ-SF).	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pain location apart from PLPP with a body chart (pregnant women)	All women will be asked whether they experience any recurrent or continuous pain apart from PLPP, and to indicate the pain locations on a body chart.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Subjective sleep quality with the Pittsburgh Sleep Quality Index (PSQI) (pregnant women)	The PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Height (pregnant women)	Height will be measured and reported in cm.	Timepoint 1 (between gestational weeks 9-16)
Pre-pregnancy body weight (pregnant women)	Pre-pregnancy body weight will be questioned and reported in kg.	Timepoint 1 (between gestational weeks 9-16)
Falls during current pregnancy or in postpartum period (pregnant women)	The investigators will ask the participants whether they have sustained any falls during their current pregnancy (number of falls, gestational week during which fall(s) occurred, situation during which fall occurred (trip, slip, during stair ascent, during stair descent, during athletic activity), and injury severity associated with fall (no injury, mild injury requiring home treatment, major injury requiring medical attention))	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pelvic floor symptoms with the PFDI-20 (pregnant women)	Pelvic floor symptoms, i.e., urinary incontinence, fecal incontinence and pelvic organ prolapse will be assessed with the validated 20-item Pelvic Floor Distress Inventory (PFDI-20). The PFDI-20 contains 20 items, total score range 0 - 300.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Workload (pregnant women)	The participants will be asked whether they worked in uncomfortable positions, performed irregular work, or did shifts during pregnancy and postpartum.	Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Low back pain, pelvic girdle pain and pain conditions (pregnant women)	The participants will be asked if they have a history of low back pain, pelvic girdle pain or other (chronic) pain conditions.	Timepoint 1 (between gestational weeks 9-16)
Previous stillbirths and live births	The number of previous stillbirths and live births will be recorded.	Timepoint 1 (between gestational weeks 9-16)
Number of falls during previous pregnancies	The investigators will ask the participants whether they have sustained any falls during their previous pregnancy (number of falls, situation during which fall occurred (trip, slip, during stair ascent, during stair descent, during athletic activity), and injury severity associated with fall (no injury, mild injury requiring home treatment, major injury requiring medical attention))	Timepoint 1 (between gestational weeks 9-16)
Urinary and anal incontinence during previous pregnancies (pregnant women)	The presence of urinary and anal incontinence during previous pregnancies (yes/no), and the recovery postpartum (full, partial, no recovery) will be questioned.	Timepoint 1 (between gestational weeks 9-16)
Information on previous deliveries (pregnant women)	For each of the previous deliveries, we will ask birth weight, maternal age at time of delivery, delivery mode (vaginal, c-section), instrumented delivery (no, forceps extraction, vacuum extraction, fundal pressure), whether the delivery was induced (yes, no), whether a vaginal tear or episiotomy was present (episiotomy, tear, no), and whether the pregnancy was through assisted reproductive treatment (yes, no).	Timepoint 1 (between gestational weeks 9-16)
History of PLPP during previous pregnancies	All participants will be asked whether they experienced PLPP during previous pregnancies (yes,no), and if yes, the total duration in weeks, the pain frequency (1= some days, 2= most days, 3= every day), whether they experienced one episode of PLPP or whether PLPP was recurrent or continuous, whether PLPP persisted postpartum and for how many weeks, and whether they sought medical help for PLPP and/or whether the pain was disabling or whether they required sick leave.	Timepoint 1 (between gestational weeks 9-16)

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: KU Leuven
• Investigators: Principal Investigator: Lotte Janssens, Prof, PhD, PT, Hasselt University; Principal Investigator: Inge Geraerts, Prof, PhD, PT, KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 21, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: inflammation; postural control; psychological factors; body perception
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Musculoskeletal Pain; Pelvic Pain; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Inflammation; Pelvic Girdle Pain; Low Back Pain; Behavioral Disciplines and Activities; Behavioral Sciences; Psychology
• Other Study ID Numbers: S69463

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No