Pelvic Girdle PainPROFitNCT04226716
The Role of Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain
A study of Pelvic Girdle Pain and Low Back Pain, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain, Low Back Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2020to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Age- and BMI- matched to pregnant participants
- Nulliparous
- Willing to provide written informed consent
Who cannot join
- Pregnant for more than 16 weeks
- Having current PPGP or having had PPGP during the current pregnancy
- History of surgery/major trauma to spine or pelvis
- Surgery/physical trauma to the lower limbs more than two years ago and currently still experiencing symptoms such as pain, instability, or stiffness
- Surgery/physical trauma to the lower limbs less than two years ago
- Specific balance or vestibular disorders
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- A medical diagnosis of a rheumatic condition or being under treatment for such a condition by a rheumatologist
- Neurological abnormalities (e.g., peripheral neuropathy)
- Uncorrected visual problems
- Acute ankle problems
- Being on absolute or relative bed rest due to pregnancy-related complications
- Having (had) a formal diagnosis of a psychiatric disorder
- Non-Dutch speaking
- Having low back or pelvic girdle pain at the time of inclusion or in the six months leading up to inclusion
- History of chronic low back or pelvic girdle pain
- History of surgery/major trauma to spine, pelvis and/or lower limbs,
- Specific balance or vestibular disorders
- Spinal deformities
- Rheumatic disease
- Neurological abnormalities
- Acute ankle problems
- (A history of) psychiatric disorders
- Uncorrected visual problems
- Non-Dutch speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Hasselt, 3590
Nina Goossens, PhD
About this study
Official title: The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women
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.
- Conditions
- Pelvic Girdle Pain, Low Back Pain
- Being tested
- Assessment of postural control, body perception, psychosocial factors and inflammation
- Keywords
- Postural control, Body perception, Psychosocial factors, Inflammation
- Medical subject headings
- Pelvic Girdle Pain, Low Back Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of postural control, body perception, psychosocial factors and inflammationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Multiparous, pregnant women | Other | Multiparous women are followed over time and measurements are performed during the first and third pregnancy trimester, and six weeks and six months postpartum. Receives: Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation |
| Nulliparous women | Other | Nulliparous women are measured at one timepoint and their data are compared to the data of the multiparous women. Nulliparous women who take part in the reliability study are measured twice. Receives: Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-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"
Measured: 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"
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))
Secondary outcomes (42)
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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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)
Measured: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Current body weight (nulliparous women)
Current body weight will be measured (kg)
Measured: Timepoint 1 (within 2 weeks after inclusion)
Current body composition (multiparous women)
Current body composition will be measured with bioelectrical impedance analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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.
Measured: Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jun 2020
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multiparous, pregnant women without PPGP at the time of inclusion are followed over a longer period of time. Assessments are performed during the first and third trimester of pregnancy and six weeks and six months postpartum. Nulliparous women without PPGP will be measured at one timepoint and their data are compared to those of the multiparous women.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Lotte Janssens, Hasselt University
- Investigators
- Lotte Janssens, PhD, PT, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226716
- Sponsor's protocol ID
- CME ZOL - CTU2019085
- Acronym
- PROFit
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2020
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women
- ClinicalTrials.gov ID
- NCT04226716
- Acronym / sponsor ID
- PROFit / CME ZOL - CTU2019085
- Conditions
- Pelvic Girdle Pain, Low Back Pain
- Keywords
- Postural control, Body perception, Psychosocial factors, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multiparous, pregnant women without PPGP at the time of inclusion are followed over a longer period of time. Assessments are performed during the first and third trimester of pregnancy and six weeks and six months postpartum. Nulliparous women without PPGP will be measured at one timepoint and their data are compared to those of the multiparous women.
| Arm | Type | Receives |
|---|---|---|
| Multiparous, pregnant women | Other | Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammationMultiparous women are followed over time and measurements are performed during the first and third pregnancy trimester, and six weeks and six months postpartum. |
| Nulliparous women | Other | Behavioral: Assessment of postural control, body perception, psychosocial factors and inflammationNulliparous women are measured at one timepoint and their data are compared to the data of the multiparous women. Nulliparous women who take part in the reliability study are measured twice. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Age- and BMI- matched to pregnant participants
Key exclusion criteria (24 listed)
- Pregnant for more than 16 weeks
- Having current PPGP or having had PPGP during the current pregnancy
- History of surgery/major trauma to spine or pelvis
- Surgery/physical trauma to the lower limbs more than two years ago and currently still experiencing symptoms such as pain, instability, or stiffness
- Surgery/physical trauma to the lower limbs less than two years ago
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of postural control, body perception, psychosocial factors and inflammationBehavioral 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 | Behavioural | Multiparous, pregnant women, Nulliparous women |
Primary outcome
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)
Time frame: Timepoint 2 (between gestational weeks 32-38)
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"
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum (multiparous women)
Time frame: Timepoint 3 (6 weeks postpartum)
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"
Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women)
Time frame: Timepoint 4 (6 months postpartum)
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"
Postural control during first gestational trimester (multiparous women)
Time frame: Timepoint 1 (before gestational week 16)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Postural control during third gestational trimester (multiparous women)
Time frame: Timepoint 2 (between gestational weeks 32-38)
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
Postural control (nulliparous women)
Time frame: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))
Upright standing balance control will be measured as center-of-pressure displacements with a force plate.
42 secondary outcomes
Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women)
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)
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)
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)
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)
Current body weight (nulliparous women)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Current body composition (multiparous women)
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)
Time frame: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)
Proprioceptive use during postural control (nulliparous women)
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)
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)
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)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (multiparous women)
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)
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)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (multiparous women)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (multiparous women)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Pregnancy-related depression with the Edinburgh Depression Scale (EDS) (multiparous women)
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)
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)
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)
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)
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)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (multiparous women)
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)
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).
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)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Optimism and pessimism with the Life Orientation Test Revised (LOT-R) (multiparous women)
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)
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)
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)
Time frame: Timepoint 1 (within 2 weeks after inclusion)
Pain frequency of PPGP (multiparous women)
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)
Time frame: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lotte Janssens, PhD, PT principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Pelvic Girdle Pain and Low Back Pain, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina Goossens, PhD, PT (+3211292174, nina.goossens@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women) (time frame: Timepoint 2 (between gestational weeks 32-38)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.