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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2028-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pelvic Girdle Pain Low Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multiparous, pregnant women

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

Group Type OTHER

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

Intervention Type 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

Nulliparous women

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.

Group Type OTHER

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

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

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

Exclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes