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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
192
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
Hasselt University
Hasselt, Belgium
RECRUITINGPregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)
The presence of PPGP in the last month will be questioned. PPGP 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, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"
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)
The presence of PPGP in the last two weeks will be questioned. PPGP 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, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"
Time frame: Timepoint 3 (6 weeks postpartum)
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women)
The presence of PPGP in the last two weeks will be questioned. PPGP 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, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"
Time frame: Timepoint 4 (6 months postpartum)
Postural control during first gestational trimester (multiparous women)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 1 (before gestational week 16)
Postural control during third gestational trimester (multiparous women)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 2 (between gestational weeks 32-38)
Postural control (nulliparous women)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time frame: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))
Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women)
The MDQ quantifies the extent of functional limitation in daily life due to low back pain: 10 items, total score range 0 - 100. Higher scores indicate higher levels of disability.
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)
The MDQ quantifies the extent of functional limitation in daily life due to low back pain: 10 items, total score range 0 - 100. Higher scores indicate higher levels of disability.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women)
The QBPDS assesses disability in individuals with low back pain and PPGP: 20 items, total score range 0 - 100. Higher scores indicate higher levels of disability.
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)
Pain intensity will be rated on the NPRS that ranges from 0 ("no pain") to 10 ("the worst pain imaginable").
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)
Individuals with PPGP will indicate the pain locations on a body chart.
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)
Current body weight will be measured (kg)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Current body weight (nulliparous women)
Current body weight will be measured (kg)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Current body composition (multiparous women)
Current body composition will be measured with bioelectrical impedance analysis.
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)
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 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)
Proprioceptive use during postural control (nulliparous 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 (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)
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 (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)
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 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (multiparous 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 (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 the Fremantle Back Awareness Questionnaire (FreBAQ) (nulliparous 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 (within 2 weeks after inclusion)
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (multiparous women)
The TSK evaluates fear of movement and pain-related fear: 17 items, total score range 17 - 68. Higher scores indicate higher levels of pain-related fear of movement.
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)
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (nulliparous women)
The TSK evaluates fear of movement and pain-related fear: 17 items, total score range 17 - 68. Higher scores indicate higher levels of pain-related fear of movement.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (multiparous women)
During the PhoDA-SEV, participants view 40 pictures of daily life activities. They will be asked to imagine themselves performing the depicted activity and to indicate to which extent they believe that the activity is harmful to their back on a scale from 0 ("not harmful at all") to 100 ("extremely harmful"): 40 items, total score range 0 - 100. Higher scores indicate a higher perceived harmfulness of physical activities.
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)
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (nulliparous women)
During the PhoDA-SEV, participants view 40 pictures of daily life activities. They will be asked to imagine themselves performing the depicted activity and to indicate to which extent they believe that the activity is harmful to their back on a scale from 0 ("not harmful at all") to 100 ("extremely harmful"): 40 items, total score range 0 - 100. Higher scores indicate a higher perceived harmfulness of physical activities.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (multiparous 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 indicate that poorer fear avoidance beliefs are held.
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)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (nulliparous 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 indicate that poorer fear avoidance beliefs are held.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (multiparous 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 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (nulliparous 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 (within 2 weeks after inclusion)
Pregnancy-related depression with the Edinburgh Depression Scale (EDS) (multiparous 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 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) (multiparous 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 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS) (multiparous women)
The TPDS assesses pregnancy-related distress: 16 items, total score range 0 - 48). Higher scores indicate higher levels of pregnancy-related stress.
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)
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (multiparous 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 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (nulliparous 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 (within 2 weeks after inclusion)
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) (multiparous women)
The LAPS comprehensively evaluates negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness): 16 items. It contains three subscores, which are calculated by adding the score on items 1-4 (Negative Affect), items 5-8 (Positive Affect) and items 9-12 (Hedonic Tone). Negative Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of negative affect. Positive Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of positive affect. Hedonic Tone subscale: 3 items, total score range 0 - 30, higher scores indicate higher levels of hedonic tone.
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)
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) (nulliparous women)
The LAPS comprehensively evaluates negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness): 16 items. It contains three subscores, which are calculated by adding the score on items 1-4 (Negative Affect), items 5-8 (Positive Affect) and items 9-12 (Hedonic Tone). Negative Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of negative affect. Positive Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of positive affect. Hedonic Tone subscale: 3 items, total score range 0 - 30, higher scores indicate higher levels of hedonic tone.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (multiparous women)
The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
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)
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (nulliparous women)
The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS).
The MAAS evaluates the emotional bond between mother and child antenatally, while the MPAS assesses this bond postnatally: 19 items, total score range 0 - 95
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)
Pain coping strategies with the Pain Coping Inventory (PCI) (multiparous women)
The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
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)
Pain coping strategies with the Pain Coping Inventory (PCI) (nulliparous women)
The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (multiparous women)
The LOT-R contains 10 items: 3 evaluating optimism, 3 evaluating pessimism and 4 filler items, total score range on each subscale (optimism, pessimism) 0 - 12.
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)
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (nulliparous women)
The LOT-R contains 10 items: 3 evaluating optimism, 3 evaluating pessimism and 4 filler items, total score range on each subscale (optimism, pessimism) 0 - 12.
Time frame: Timepoint 1 (within 2 weeks after inclusion)
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (multiparous women)
The SOC-13 contains 13 items, total score ranges 0 - 91
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)
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (nulliparous women)
The SOC-13 contains 13 items, total score ranges 0 - 91
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Pain frequency of PPGP (multiparous women)
Pain frequency will be assessed with the question: 'How often do you experience pain?' Response options will include: Some days (1), Most days (2), and Every day (3).
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (multiparous 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
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (nulliparous 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
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Inflammation with blood samples (multiparous women)
Serum concentrations of inflammatory mediators will be measured in a blood sample.
Time frame: Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)