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

Primary Purpose

Pelvic Girdle Pain, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Assessment of postural control, body perception and psychosocial factors
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pelvic Girdle Pain focused on measuring Postural control, Body perception, Psychosocial factors

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hasselt UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Multiparous, pregnant women

Arm Description

Outcomes

Primary Outcome Measures

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"
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"
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"
Postural control during first gestational trimester
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Postural control during third gestational trimester
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.

Secondary Outcome Measures

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.
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.
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").
Pain location of PPGP with a body chart
Individuals with PPGP will indicate the pain locations on a body chart.
Current body weight
Current body weight will be measured (kg)
Current body composition
Current body composition will be measured with bioelectrical impedance analysis.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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
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
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.
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

Full Information

First Posted
January 5, 2020
Last Updated
September 25, 2023
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
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1. Study Identification

Unique Protocol Identification Number
NCT04226716
Brief Title
The Role of Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study
Acronym
PROFit
Official Title
The Role of Lumbar Proprioceptive Deficits and Psychosocial Factors in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain, Low Back Pain
Keywords
Postural control, Body perception, Psychosocial factors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multiparous, pregnant women
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Assessment of postural control, body perception and psychosocial factors
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester
Description
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"
Time Frame
Timepoint 2 (between gestational weeks 34-38)
Title
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum
Description
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"
Time Frame
Timepoint 3 (6 weeks postpartum)
Title
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum
Description
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"
Time Frame
Timepoint 4 (6 months postpartum)
Title
Postural control during first gestational trimester
Description
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Postural control during third gestational trimester
Description
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Time Frame
Timepoint 2 (between gestational weeks 34-38)
Secondary Outcome Measure Information:
Title
Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ)
Description
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 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS)
Description
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 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS)
Description
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 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pain location of PPGP with a body chart
Description
Individuals with PPGP will indicate the pain locations on a body chart.
Time Frame
Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Current body weight
Description
Current body weight will be measured (kg)
Time Frame
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)
Title
Current body composition
Description
Current body composition will be measured with bioelectrical impedance analysis.
Time Frame
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)
Title
Proprioceptive use during postural control
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38)
Title
Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app)
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ).
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK).
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV).
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS)
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pregnancy-related depression with the Edinburgh Depression Scale (EDS)
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2)
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS).
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21)
Description
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 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
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)
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7)
Description
The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.
Time Frame
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)
Title
The emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS).
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Pain coping strategies with the Pain Coping Inventory (PCI)
Description
The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100
Time Frame
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)
Title
Optimism and pessimism with the Life Orientation Test Revised (LOT-R)
Description
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 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13)
Description
The SOC-13 contains 13 items, total score ranges 0 - 91
Time Frame
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)
Other Pre-specified Outcome Measures:
Title
Diagnostic clinical tests for PPGP
Description
The following pain provocation tests for PPGP will be performed: thigh thrust, flexion abduction external rotation (Faber), Gaenslen's test, sacral distraction, lateral compression and sacral thrust. A score of 1 will be assigned to each test that provokes the participants' pain, a score of 0 will be assigned to each test that does not provoke the pain. All scores will be combined into one overall score.
Time Frame
Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Ability to transfer load between the spine and the legs via the pelvis with active straight leg raise test (ASLR).
Description
The participant will perform the ASLR test in supine lying: she will be asked to lift one leg 20 cm off the bed, and a score between 0 and 5 will be assigned depending on the difficulty experienced (0= "not difficult at all, 1= minimally difficult, 2= somewhat difficult, 3 = fairly difficult, 4= very difficult, 5= unable to do).
Time Frame
Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Title
Sociodemographic information: age
Description
The age of the participant will be noted (in years)
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Sociodemographic information: annual household income
Description
Annual household income will be questioned (in Euro)
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Sociodemographic information: marital status
Description
Marital status be questioned (single, married/registered partnership)
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Sociodemographic information: educational level
Description
The highest degree obtained will be recorded.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Sociodemographic information: current profession
Description
The current profession will be recorded, as well as the type of work (sedentary work, manual work, heavy work)
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Number of previous pregnancies
Description
The number of previous pregnancies will be recorded.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Number of previous child deliveries
Description
The number of previous child deliveries will be recorded.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Number of previous miscarriages
Description
The number of previous miscarriages will be recorded.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Job status
Description
Job status will be recorded (i.e., working full-time, working part-time, in sick leave) In case of sick leave, we will ask whether this is pregnancy-related or not, and the total number of sick leave days will be noted.
Time Frame
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)
Title
Tobacco use
Description
Smoking habits will be questioned by using the following categories: every day smoker (smokes now and smokes every day), someday smoker (smokes now, but not every day), former smoker (has quit smoking), never smoker
Time Frame
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)
Title
Alcohol use
Description
Alcohol use will be questioned by using the following categories: every day drinker (drinks now and drinks every day), someday drinker (drinks now, but not everyday), former drinker (has quit drinking now), never drinker.
Time Frame
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)
Title
Habitual physical activity
Description
Habitual physical activity will be questioned using the following categories: regular (> 1x/week), occasional (≤1x/week), never.
Time Frame
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)
Title
Subjective sleep quality with the Pittsburgh Sleep Quality Index (PSQI)
Description
The PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21
Time Frame
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)
Title
Height
Description
Height will be measured and reported in cm.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Pre-pregnancy body weight
Description
Pre-pregnancy body weight will be questioned and reported in kg.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Number of falls during previous pregnancies
Description
The number of falls experienced during previous pregnancies will be noted. The following question will be asked: "During your previous pregnancies, did you experience any loss of balance, resulting in a fall where some part of your body--other than your feet--touched the ground?"
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Gestational week during which fall occurred during previous pregnancies
Description
If the participant experienced a fall during a previous pregnancy, the gestational week during which the fall(s) occurred will be noted.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Situation during which fall occurred during previous pregnancies
Description
If the participant experienced a fall during a previous pregnancy, the situation during which the falls occurred will be noted, by using the following categories: trip, slip, during stair ascent, during stair descent, during athletic activity.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Injury severity of falls that occurred during previous pregnancies
Description
If the participant experienced a fall during a previous pregnancy, the injury severity associated with the falls will be noted by using the following categories: no injury, mild injury requiring home treatment, major injury requiring medical attention
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Urinary incontinence during previous pregnancies
Description
The presence of urinary incontinence during previous pregnancies (yes/no), and the recovery of urinary incontinence postpartum (full, partial, no recovery) will be questioned.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Participation in pre- and postnatal physiotherapy during previous pregnancies
Description
Participation in pre- and postnatal physiotherapy during previous pregnancies (yes/no and types of interventions) will be questioned.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Information on previous deliveries: child's birth weight
Description
The birth weight of the previously born child will be noted in grams
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Information on previous deliveries: vaginal delivery or caesarean section
Description
We will ask whether the previous deliveries were vaginal deliveries of caesarean sections.
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Information on previous deliveries: breastfeeding
Description
We will ask whether the previous children received breastfeeding
Time Frame
Timepoint 1 (between gestational weeks 9-14)
Title
Number of falls during current pregnancy or in postpartum period
Description
The number of falls experienced during the current pregnancy or postpartum period will be noted. The following question will be asked: "Did you experience any loss of balance, resulting in a fall where some part of your body--other than your feet--touched the ground?"
Time Frame
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)
Title
Timepoint during which fall occurred during current pregnancy or postpartum period
Description
If the participant experienced a fall during or after the current pregnancy, the timepoint during which this fall occurred wil be noted.
Time Frame
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)
Title
Situation during which fall occurred during current pregnancy or postpartum period
Description
If the participant experienced a fall during or after the current pregnancy, the situation during which the falls occurred will be noted, by using the following categories: trip, slip, during stair ascent, during stair descent, during athletic activity.
Time Frame
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)
Title
Injury severity of falls that occurred during current pregnancy or postpartum period
Description
If the participant experienced a fall during or after the current pregnancy, the injury severity associated with the falls will be noted by using the following categories: no injury, mild injury requiring home treatment, major injury requiring medical attention
Time Frame
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)
Title
Urinary incontinence during current pregnancy
Description
Urinary incontinence will be evaluated with the Pelvic Floor Distress Inventory (PFDI-20). The PFDI-20 contains 20 items, total score range 0 - 300
Time Frame
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nina Goossens, PhD, PT
Phone
+3211292174
Email
nina.goossens@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lotte Janssens, PhD, PT
Phone
+3211292174
Email
lotte.janssens@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Janssens, PhD, PT
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hasselt University
City
Hasselt
ZIP/Postal Code
3590
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Goossens, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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