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

NCT06785909 | Recruiting

• 1 other identifier: S69463
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain; Lumbopelvic Pain; Pelvic Girdle Pain

Keywords

postural control; body perception; psychological factors; inflammation

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (10)

• Disability due to PLPP with the Modified Oswestry Disability Index (mODI) (pregnant women)

  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)

  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)

  Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)

• Pain frequency of PLPP (pregnant women)

  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)

  Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)

Other Outcomes (23)

• Diagnostic clinical tests for PLPP (pregnant women)

  Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)

• Sociodemographic information: age (pregnant women)

  Timepoint 1 (between gestational weeks 9-16)

• Sociodemographic information: annual household income (pregnant women)

  Timepoint 1 (between gestational weeks 9-16)

Study Arms (1)

Primiparous pregnant women

OTHER

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

Interventions

Assessment of postural control, body perception, psychosocial factors and inflammation BEHAVIORAL

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.

Primiparous pregnant women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent to participate
• years old
• Pregnant
• Singleton pregnancy (confirmed through ultrasound)
• No current PLPP
• Dutch- or English-speaking

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hasselt University: lead
• KU Leuven: collaborator

Study Sites (2)

Hasselt University

Hasselt, Belgium

RECRUITING

KU Leuven

Leuven, Belgium

RECRUITING

MeSH Terms

Conditions

Low Back Pain; Pelvic Girdle Pain; Inflammation

Interventions

Psychology

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Musculoskeletal Pain; Pelvic Pain; Pathologic Processes

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Lotte Janssens, Prof, PhD, PT

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Inge Geraerts, Prof, PhD, PT

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte Janssens, Prof, PhD

CONTACT

+32 474 43 56 39; lotte.janssens@uhasselt.be

Inge Geraerts, Prof, PhD

CONTACT

+32 16 32 91 20; inge.geraerts@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: 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.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 21, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)