The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain

NCT04226716 | Recruiting DMC

• 1 other identifier: CME ZOL - CTU2019085
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

A large proportion of pregnant women develop pregnancy-related low back and/or pelvic girdle pain (PPGP), which often does not recover spontaneously postpartum. As a result, 10% of women with PPGP are thus crucial. However, the underlying mechanisms of PPGP are still poorly understood. The main objective of this study is to investigate whether lumbar proprioceptive deficits, a disturbed body perception at the lumbar spine, psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) and increased serum concentrations of specific inflammatory mediators are associated with (1) a reduced postural control and (2) the development and/or persistence of PPGP in multiparous women during the first and third trimester of pregnancy, and six weeks and six months postpartum.

Conditions

Low Back Pain; Pelvic Girdle Pain

Keywords

Postural control; Body perception; Psychosocial factors; Inflammation

Outcome Measures

Primary Outcomes (6)

• Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)

  The presence of PPGP in the last month will be questioned. PPGP 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, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"

  Timepoint 2 (between gestational weeks 32-38)

• Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum (multiparous women)

  The presence of PPGP in the last two weeks will be questioned. PPGP 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, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"

  Timepoint 3 (6 weeks postpartum)

• Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women)

  The presence of PPGP in the last two weeks will be questioned. PPGP 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, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"

  Timepoint 4 (6 months postpartum)

• Postural control during first gestational trimester (multiparous women)

  Upright standing balance control will be measured as center-of-pressure displacements with a force plate.

  Timepoint 1 (before gestational week 16)

• Postural control during third gestational trimester (multiparous women)

  Upright standing balance control will be measured as center-of-pressure displacements with a force plate.

  Timepoint 2 (between gestational weeks 32-38)

• Postural control (nulliparous women)

  Upright standing balance control will be measured as center-of-pressure displacements with a force plate.

  Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))

Secondary Outcomes (42)

• Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women)

  Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

• Disability due to low back pain with the Modified Low Back Pain Disability Questionnaire (MDQ) (nulliparous women)

  Timepoint 1 (within 2 weeks after inclusion)

• Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women)

  Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

• Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS) (multiparous women)

  Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

• Pain location of PPGP with a body chart (multiparous women)

  Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

Other Outcomes (54)

• Diagnostic clinical tests for PPGP (multiparous women)

  Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

• Ability to transfer load between the spine and the legs via the pelvis with active straight leg raise test (ASLR) (multiparous women)

  Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

• Sociodemographic information: age (multiparous women)

  Timepoint 1 (before gestational week 16)

Study Arms (2)

Multiparous, pregnant women

OTHER

Multiparous women are followed over time and measurements are performed during the first and third pregnancy trimester, and six weeks and six months postpartum.

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

Nulliparous women

OTHER

Nulliparous women are measured at one timepoint and their data are compared to the data of the multiparous women. Nulliparous women who take part in the reliability study are measured twice.

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. perceived harmfulness of daily activities, pain-related fear of movement, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress, optimism/pessimism, pain coping and coping with stressful life events) and inflammatory mediators

Multiparous, pregnant women; Nulliparous women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Pregnant of second child or more than second child
• No current PPGP or did not have PPGP during current pregnancy
• Willing to provide written informed consent

You may not qualify if:

• Pregnant for more than 16 weeks
• Having current PPGP or having had PPGP during the current pregnancy
• History of surgery/major trauma to spine or pelvis
• Surgery/physical trauma to the lower limbs more than two years ago and currently still experiencing symptoms such as pain, instability, or stiffness
• Surgery/physical trauma to the lower limbs less than two years ago
• Specific balance or vestibular disorders
• A medical diagnosis of a rheumatic condition or being under treatment for such a condition by a rheumatologist
• Neurological abnormalities (e.g., peripheral neuropathy)
• Uncorrected visual problems
• Acute ankle problems
• Being on absolute or relative bed rest due to pregnancy-related complications
• Having (had) a formal diagnosis of a psychiatric disorder
• Non-Dutch speaking
• Age- and BMI- matched to pregnant participants
• Nulliparous

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Hasselt University

Hasselt, 3590, Belgium

RECRUITING

MeSH Terms

Conditions

Pelvic Girdle Pain; Low Back Pain; Inflammation

Interventions

Psychology

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• Lotte Janssens, PhD, PT

  Hasselt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Goossens, PhD, PT

CONTACT

+3211292174; nina.goossens@uhasselt.be

Lotte Janssens, PhD, PT

CONTACT

+3211292174; lotte.janssens@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multiparous, pregnant women without PPGP at the time of inclusion are followed over a longer period of time. Assessments are performed during the first and third trimester of pregnancy and six weeks and six months postpartum. Nulliparous women without PPGP will be measured at one timepoint and their data are compared to those of the multiparous women.

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: January 13, 2020
• Study Start: June 1, 2020
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)