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Recruiting NCT04226716

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

No phase Interventional Pelvic Girdle Pain Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of postural control, body perception, psychosocial factors and inflammation.
Who it may be relevant to
Registry conditions: Pelvic Girdle Pain, Low Back Pain. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women

Overview

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.

Interventions

  • 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. 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

Primary outcome measures

  • Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women) [Time frame: Timepoint 2 (between gestational weeks 32-38)]
  • Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum (multiparous women) [Time frame: Timepoint 3 (6 weeks postpartum)]
  • Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women) [Time frame: Timepoint 4 (6 months postpartum)]
  • Postural control during first gestational trimester (multiparous women) [Time frame: Timepoint 1 (before gestational week 16)]
  • Postural control during third gestational trimester (multiparous women) [Time frame: Timepoint 2 (between gestational weeks 32-38)]
  • Postural control (nulliparous women) [Time frame: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))]
Secondary outcome measures (12)
  • Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women) [Time frame: 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) [Time frame: Timepoint 1 (within 2 weeks after inclusion)]
  • Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women) [Time frame: 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) [Time frame: 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) [Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)]
  • Current body weight (multiparous women) [Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)]
  • Current body weight (nulliparous women) [Time frame: Timepoint 1 (within 2 weeks after inclusion)]
  • Current body composition (multiparous women) [Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)]
  • Proprioceptive use during postural control (multiparous women) [Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)]
  • Proprioceptive use during postural control (nulliparous women) [Time frame: Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)]
  • Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (multiparous women) [Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)]
  • Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (nulliparous women) [Time frame: Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)]

Eligibility criteria

Inclusion Criteria Multiparous Women:

  • 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

Exclusion Criteria Multiparous Women:

  • 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

Inclusion Criteria Nulliparous Women:

  • Age- and BMI- matched to pregnant participants
  • Nulliparous
  • Willing to provide written informed consent

Exclusion Criteria Nulliparous Women:

  • Having low back or pelvic girdle pain at the time of inclusion or in the six months leading up to inclusion
  • History of chronic low back or pelvic girdle pain
  • History of surgery/major trauma to spine, pelvis and/or lower limbs,
  • Specific balance or vestibular disorders
  • Spinal deformities
  • Rheumatic disease
  • Neurological abnormalities
  • Acute ankle problems
  • (A history of) psychiatric disorders
  • Uncorrected visual problems
  • Non-Dutch speaking

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Belgium · 1 center
  • Hasselt University — Hasselt

Identifiers

NCT: NCT04226716 · CME ZOL - CTU2019085

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗