The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain

Not Applicable

Recruiting

• Conditions: Pelvic Girdle Pain; Low Back Pain

• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-06-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-15
• Primary Completion: 2027-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)	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 weeks postpartum (multiparous women)	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"
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women)	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 first gestational trimester (multiparous women)	Timepoint 1 (between gestational weeks 9-14)	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Postural control during third gestational trimester (multiparous women)	Timepoint 2 (between gestational weeks 34-38)	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Postural control (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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) (multiparous women)	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.
Disability due to low back pain with the Modified Low Back Pain Disability Questionnaire (MDQ) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women)	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.
Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS) (multiparous women)	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").
Pain location of PPGP with a body chart (multiparous women)	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 (multiparous women)	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)
Current body weight (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	Current body weight will be measured (kg)
Current body composition (multiparous women)	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.
Proprioceptive use during postural control (multiparous women)	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.
Proprioceptive use during postural control (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (multiparous women)	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.
Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (multiparous women)	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.
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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) (multiparous women)	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.
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (multiparous women)	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.
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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) (multiparous women)	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.
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (multiparous women)	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.
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
Pregnancy-related depression with the Edinburgh Depression Scale (EDS) (multiparous women)	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) (multiparous women)	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.
Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS) (multiparous women)	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.
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (multiparous women)	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).
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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).
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)	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.
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)	Timepoint 1 (within 2 weeks after inclusion)	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.
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (multiparous women)	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.
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
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
Pain coping strategies with the Pain Coping Inventory (PCI) (multiparous women)	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
Pain coping strategies with the Pain Coping Inventory (PCI) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (multiparous women)	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.
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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.
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (multiparous women)	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
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	The SOC-13 contains 13 items, total score ranges 0 - 91
Pain frequency of PPGP with Ordinal Pain Rating Scale (OPRS) (multiparous women)	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)	Pain frequency will be rated on an ordinal scale, asking about the amount of pain experienced in the morning and evening, that ranges from "none" (0) to "considerable" (3).
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (multiparous women)	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)	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
Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (nulliparous women)	Timepoint 1 (within 2 weeks after inclusion)	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
Inflammation with blood samples (multiparous women)	Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)	Serum concentrations of inflammatory mediators will be measured.

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Belgium