The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study

Study Overview
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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 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.

Official Title
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The Role of Lumbar Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women

Conditions
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Pelvic Girdle Pain, Low Back Pain

Intervention / Treatment
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* Behavioral: Assessment of postural control, body perception and psychosocial factors


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multiparous, pregnant women<br> | Behavioral: Assessment of postural control, body perception and psychosocial factors<br>* Behavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception and 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester | The presence of PPGP will be questioned at each timepoint. 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 | Timepoint 2 (between gestational weeks 34-38) | 
| Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum | The presence of PPGP will be questioned at each timepoint. 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 | Timepoint 3 (6 weeks postpartum) | 
| Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum | The presence of PPGP will be questioned at each timepoint. 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 | Timepoint 4 (6 months postpartum) | 
| Postural control during first gestational trimester | Upright standing balance control will be measured as center-of-pressure displacements with a force plate. | Timepoint 1 (between gestational weeks 9-14) | 
| Postural control during third gestational trimester | Upright standing balance control will be measured as center-of-pressure displacements with a force plate. | Timepoint 2 (between gestational weeks 34-38) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) | 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. | Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) | 
| Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) | 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. | Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) | 
| Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS) | Pain intensity will be rated on the NPRS that ranges from 0 (no pain) to 10 (the worst pain imaginable). | Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) | 
| Pain location of PPGP with a body chart | Individuals with PPGP will indicate the pain locations on a body chart. | Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) | 
| Current body weight | Current body weight will be measured (kg) | 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) | 
| Current body composition | Current body composition will be measured with bioelectrical impedance analysis. | 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) | 
| Proprioceptive use during postural control | 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. | Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38) | 
| Body perception at the lumbar spine will be assessed with a laterality recognition task (Recognise Back app) | 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. | 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) | 
| Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ). | The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception. | 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) | 
| Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK). | 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. | 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) | 
| Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV). | 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. | 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) | 
| Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) | 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. | 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) | 
| Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) | 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. | 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) | 
| Pregnancy-related depression with the Edinburgh Depression Scale (EDS) | The EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression. | 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) | 
| Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) | The PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety. | 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) | 
| Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS). | The TPDS assesses pregnancy-related distress: 16 items, total score range 0 - 48). Higher scores indicate higher levels of pregnancy-related stress. | 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) | 
| Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) | 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). | 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) | 
| 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) | 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. | 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) | 
| Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) | The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21. | 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) | 
| 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 | 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) | 
| Pain coping strategies with the Pain Coping Inventory (PCI) | The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100 | 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) | 
| Optimism and pessimism with the Life Orientation Test Revised (LOT-R) | 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. | 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) | 
| The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) | The SOC-13 contains 13 items, total score ranges 0 - 91 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postural control, Body perception, Psychosocial factors