The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study
- Conditions
- Pelvic Girdle PainLow Back Pain
- Interventions
- Behavioral: Assessment of postural control, body perception and psychosocial factors
- Registration Number
- NCT04226716
- Lead Sponsor
- Hasselt University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 140
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Multiparous, pregnant women Assessment of postural control, body perception and psychosocial factors -
- Primary Outcome Measures
Name Time Method Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester Timepoint 2 (between gestational weeks 34-38) 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"
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum Timepoint 4 (6 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"
Postural control during third gestational trimester Timepoint 2 (between gestational weeks 34-38) Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum Timepoint 3 (6 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"
Postural control during first gestational trimester Timepoint 1 (between gestational weeks 9-14) Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
- Secondary Outcome Measures
Name Time Method Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) 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.
Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS) Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) Pain intensity will be rated on the NPRS that ranges from 0 ("no pain") to 10 ("the worst pain imaginable").
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ). 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 FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK). 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 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.
Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS). 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 TPDS assesses pregnancy-related distress: 16 items, total score range 0 - 48). Higher scores indicate higher levels of pregnancy-related stress.
Current body composition 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 will be measured with bioelectrical impedance analysis.
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) 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 GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) 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 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.
Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) 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.
Proprioceptive use during postural control Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38) 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.
Pain location of PPGP with a body chart Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum) Individuals with PPGP will indicate the pain locations on a body chart.
Current body weight 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 weight will be measured (kg)
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV). 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) 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.
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) 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 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.
Pregnancy-related depression with the Edinburgh Depression Scale (EDS) 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 EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression.
Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) 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 PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety.
Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) 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) 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.
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) 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 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.
The emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS). 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 MAAS evaluates the emotional bond between mother and child antenatally, while the MPAS assesses this bond postnatally: 19 items, total score range 0 - 95
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-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 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).
Pain coping strategies with the Pain Coping Inventory (PCI) 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 PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) 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 SOC-13 contains 13 items, total score ranges 0 - 91
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) 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 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.
Trial Locations
- Locations (1)
Hasselt University
🇧🇪Hasselt, Belgium