Pregnancy-related lumbopelvic pain (PLPP) affects 50-90% of pregnant women and is often dismissed as a normal part of pregnancy. However, the long-term consequences can be dramatic. Up to 21% of women with PLPP still have pain three years postpartum, and 10% experience disability, poorer quality of life, and lower ability to work 11 years after delivery. Because the multifactorial etiology of PLPP is unclear, prevention and treatment fall short. Previous studies on the causes of PLPP focused on impairments in motor output but ignored that impairments in sensory input (e.g., proprioception, the primary expertise of our research group) often precede motor output problems. Moreover, though psychological factors such as fear (of movement) are known to affect PLPP, their predictive role in PLPP remains understudied. Finally, the role of systemic inflammation in PLPP has yet to be examined, despite recent studies demonstrating its role in the chronification of lumbopelvic pain in the general population. This prospective cohort study aims to identify new modifiable predictors for the onset of PLPP during pregnancy and its persistence postpartum. The investigators will compare sensory (proprioception, body perception), fear-related, and inflammatory factors between women with and without PLPP and determine their predictive role in the onset and persistence of PLPP. The results will increase our understanding of the multifactorial etiology of PLPP and help optimize prevention and treatment.
This study comprises a prospective cohort study with three objectives. Objective 1 is to investigate whether the reliance on lumbar versus ankle proprioception during standing and body perception at the lower back (i.e., "proprioceptive factors"), anxiety, fear of movement, pain catastrophizing, depression, stress, and coping with stressful situations (i.e. "fear-related factors"), and inflammatory markers (i.e., "inflammatory factors") change over time and differ between women with and without PLPP in the 3rd pregnancy trimester, 6 weeks postpartum, and 9 months postpartum. We hypothesize that women with PLPP show (1a) a maladaptive reliance on ankle proprioception and/or disturbed body perception at the lower back, (1b) higher levels of fear of movement, anxiety, stress, depression, pain catastrophizing and poorer coping with stress, and (1c) greater immune activation and a disturbed balance of pro- vs. anti-inflammatory markers compared to pain-free women. Objective 2 is to determine whether the proprioceptive, fear-related, and inflammatory factors are correlated in women with PLPP. Based on previous findings, we hypothesize that anxiety correlates with higher concentrations of IL-6 and IL-12, and lower concentrations of IL-2 and IL-10. We will also examine whether maladaptive reliance on ankle proprioception and disturbed body perception at the lower back correlate with fear of movement, anxiety, and concentrations of inflammatory markers in women with PLPP. Objective 3 is to investigate whether the proprioceptive, fear-related, and inflammatory factors predict the presence of PLPP in the 3rd trimester, 6 weeks postpartum and 9 months postpartum. Based on previous research, we hypothesize that a maladaptive reliance on ankle proprioception and disturbed body perception at the lower back, higher levels of anxiety and fear of movement, and immune activation and disturbed balance of pro- and anti-inflammatory markers in the 1st trimester predict having PLPP in the 3rd trimester. We also expect that the presence of these factors in the 3rd trimester predicts the persistence of PLPP 6 weeks and 9 months postpartum.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
211
Behavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception, psychosocial factors (incl. fear of movement, pain catastrophizing, sense of coherence, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress) and inflammatory mediators.
Hasselt University
Hasselt, Belgium
RECRUITINGKU Leuven
Leuven, Belgium
RECRUITINGPregnancy-related lumbopelvic pain (PLPP) (pregnant women)
The presence of PLPP will be questioned at each timepoint. PLPP 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, articularly in the vicinity of the sacroiliac joints, that may radiate to the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis."
Time frame: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Postural control (pregnant women)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Proprioceptive use during postural control (pregnant women)
Center-of-pressure displacements in response to ankle muscle and lower back muscle vibration (60 Hz, 15s) during upright standing will be measured with a force plate.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Inflammation with blood samples (pregnant women)
Serum concentrations of inflammatory mediators will be measured.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Task-related fear of movement (pregnant women)
Participants will be asked whether they are reluctant to perform any movement or activity in which their lower back or pelvis is involved, because they might have some concerns. If so, they are asked to specify the concerns and describe the movements or activities. For each of the activities, they will be asked to rate their (1) pain intensity, (2) perceived harmfulness, (3) fear, and (4) self-efficacy to perform the task, all via a Visual Analogue Scale (VAS) with 0= no pain/harmfulness/fear/self-efficacy to 100= maximal pain/harmfulness/fear/self-efficacy.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (pregnant women)
The SOC-13 contains 13 items, total score ranges 0 - 91.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (pregnant women)
The DASS-21 evaluates depressive mood, anxiety and stress in general: 21 items, total score per subscale (Depression, Stress, Anxiety) range 0 - 21. Higher scores indicate higher levels of depressive mood (DASS-21-Depression), anxiety (DASS-21-Anxiety) and stress (DASS-21-Stress).
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) (pregnant women)
The PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36)
Pregnancy-related depression with the Edinburgh Depression Scale (EDS)(pregnant women)
The EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (pregnant women)
The PCS contains 13 statements on thoughts and emotions possibly related to the experience of pain, for which the participants rates her agreement: 13 items, total score range 0 - 52. Higher scores indicate higher levels of pain catastrophizing.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Body perception at the lumbar spine assessed with a laterality recognition task ("Recognise Back" app) (pregnant women)
During the laterality recognition task, participants view 40 pictures of a model that has its lower back bent or rotated to the left or the right side. They will be asked to judge the direction of movement as quickly and accurately as possible. Average speed (in seconds) of response time and average accuracy of the answers (in %) will be recorded.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Body perception at the lumbar spine assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (pregnant women)
The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Disability due to PLPP with the Modified Oswestry Disability Index (mODI) (pregnant women)
The ODI is a 10-item self-report questionnaire that quantifies the extent of functional limitation in daily life due to low back pain. Each item is given a score between 0 (no limitation) and 5 (maximal limitation). The sum of the scores is multiplied by 2 to obtain a percentage score, with higher scores representing greater functional disability
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Disability due to PLPP with the Quebec Back Pain Disability Scale (QBPDS) (pregnant women)
The QBPDS assesses disability in individuals with low back pain and PLPP: 20 items, total score range 0 - 100. Higher scores indicate higher levels of disability.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pain intensity of PLPP with Visual Analogue Scale (VAS) (pregnant women)
The participants will be asked to rate the pain intensity at the lower back or pelvic girdle they experience at this moment (i.e., both at the start and the end of the full test procedure), the average pain intensity during the past week, the minimal pain intensity during the past week, and the maximal pain intensity during the past week, by using the Visual Analogue Scale (VAS, 0-100), with 0 = "no pain" and 100 = "the worst pain imaginable".
Time frame: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pain frequency of PLPP (pregnant women)
The participants will be asked how often they experience pain (1= some days, 2= most days, 3= every day)
Time frame: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (pregnant women)
The SF-36 evaluates health-related quality of life, 8 scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Scores for the different scales are converted and pooled using a scoring key, for a total score ranging 0 - 100
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Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (pregnant women)
The FABQ consists of 16 statements for which the participant rates her agreement with the statement on a scale from 0 ("completely disagree") to 6 ("completely agree"): 16 items, total score range 0 - 96). Higher scores on the FABQ indicated more strongly held fear-avoidance beliefs.
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Pain location of PLPP with a body chart (pregnant women)
Individuals with PLPP will indicate the pain locations on a body chart.
Time frame: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Current body weight (pregnant women)
Current body weight will be measured (kg)
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)
Current fat mass (in kg) and fat-free mass (in kg) (pregnant women)
Current fat mass and fat-free mass (in kg) will be measured using bioelectrical impedance analysis (Bodystat 1500, EuroMedix).
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), and Timepoint 4 (9 months postpartum)
Current total body water (in liter) (pregnant women)
Current total body water (in liter) will be measured using bioelectrical impedance analysis (Bodystat 1500, EuroMedix).
Time frame: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), and Timepoint 4 (9 months postpartum)