Clinical trial NCT04226716: The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study
Official title: The Role of Lumbar Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pelvic Girdle Pain
Low Back Pain
Keywords: Postural control
Body perception
Psychosocial factors
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2020-01-13
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiparous, pregnant women without PPGP at the time of inclusion are followed over a longer period of time, and assessments are performed during the first and third trimester of pregnancy and six weeks and six months postpartum.
Primary purpose: DIAGNOSTIC

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 still reports complaints a decade after delivery. The prevention and treatment of 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 and psychosocial factors (incl. pain-related fear of movement, depression, anxiety and stress) 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.


Eligibility criteria: 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

Exclusion Criteria:

* Pregnant for more than 14 weeks
* Having current PPGP or having had PPGP during the current pregnancy
* History of surgery/major trauma to spine, pelvis and/or lower limbs,
* Specific balance or vestibular disorders
* Spinal deformities
* Rheumatic disease
* Neurological abnormalities (e
* Hyperemesis gravidarum
* Acute ankle problems
* Pre-existing disorders that could interfere with the course of pregnancy (e.g., hypertension, kidney disease, coagulation disorders)
* (A history of) psychiatric disorders
* Non-Dutch speaking

Primary outcomes:
measure: Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester
timeFrame: Timepoint 2 (between gestational weeks 34-38)
measure: Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum
timeFrame: Timepoint 3 (6 weeks postpartum)
measure: Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum
timeFrame: Timepoint 4 (6 months postpartum)
measure: Postural control during first gestational trimester
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Postural control during third gestational trimester
timeFrame: Timepoint 2 (between gestational weeks 34-38)
Secondary outcomes:
measure: Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ)
timeFrame: Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS)
timeFrame: Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS)
timeFrame: Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pain location of PPGP with a body chart
timeFrame: Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Current body weight
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Current body composition
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Proprioceptive use during postural control
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38)
measure: Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ).
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK).
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV).
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pregnancy-related depression with the Edinburgh Depression Scale (EDS)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS).
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness) with the Leuven Affect Pleasure Scale (LAPS)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: The emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS).
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Pain coping strategies with the Pain Coping Inventory (PCI)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Optimism and pessimism with the Life Orientation Test Revised (LOT-R)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Other outcomes:
measure: Diagnostic clinical tests for PPGP
timeFrame: Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Ability to transfer load between the spine and the legs via the pelvis with active straight leg raise test (ASLR).
timeFrame: Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Sociodemographic information: age
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Sociodemographic information: annual household income
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Sociodemographic information: marital status
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Sociodemographic information: educational level
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Sociodemographic information: current profession
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Number of previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Number of previous child deliveries
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Number of previous miscarriages
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Job status
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Tobacco use
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Alcohol use
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Habitual physical activity
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Subjective sleep quality with the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Height
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Pre-pregnancy body weight
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Number of falls during previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Gestational week during which fall occurred during previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Situation during which fall occurred during previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Injury severity of falls that occurred during previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Urinary incontinence during previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Participation in pre- and postnatal physiotherapy during previous pregnancies
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Information on previous deliveries: child's birth weight
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Information on previous deliveries: vaginal delivery or caesarean section
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Information on previous deliveries: breastfeeding
timeFrame: Timepoint 1 (between gestational weeks 9-14)
measure: Number of falls during current pregnancy or in postpartum period
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Timepoint during which fall occurred during current pregnancy or postpartum period
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Situation during which fall occurred during current pregnancy or postpartum period
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Injury severity of falls that occurred during current pregnancy or postpartum period
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
measure: Urinary incontinence during current pregnancy
timeFrame: Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Lotte Janssens, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: