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

Hasselt University

Status: Enrolling

Conditions: Pelvic Girdle Pain; Low Back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04226716

CME ZOL - CTU2019085

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

Multiparous, pregnant women

Other group

Description:

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

Treatment:

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

Nulliparous women

Other group

Description:

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.

Treatment:

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