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

Low Back Pain Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226716
• Other study ID #: CME ZOL - CTU2019085
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Hasselt University
• Contact: Nina Goossens, PhD, PT
• Phone: +3211292174
• Email: nina.goossens[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain
• Pelvic Girdle Pain

Intervention

Behavioral:
• Assessment of postural control, body perception and psychosocial factors
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)

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic clinical tests for PPGP	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.	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Other	Ability to transfer load between the spine and the legs via the pelvis with active straight leg raise test (ASLR).	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).	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Other	Sociodemographic information: age	The age of the participant will be noted (in years)	Timepoint 1 (between gestational weeks 9-14)
Other	Sociodemographic information: annual household income	Annual household income will be questioned (in Euro)	Timepoint 1 (between gestational weeks 9-14)
Other	Sociodemographic information: marital status	Marital status be questioned (single, married/registered partnership)	Timepoint 1 (between gestational weeks 9-14)
Other	Sociodemographic information: educational level	The highest degree obtained will be recorded.	Timepoint 1 (between gestational weeks 9-14)
Other	Sociodemographic information: current profession	The current profession will be recorded, as well as the type of work (sedentary work, manual work, heavy work)	Timepoint 1 (between gestational weeks 9-14)
Other	Number of previous pregnancies	The number of previous pregnancies will be recorded.	Timepoint 1 (between gestational weeks 9-14)
Other	Number of previous child deliveries	The number of previous child deliveries will be recorded.	Timepoint 1 (between gestational weeks 9-14)
Other	Number of previous miscarriages	The number of previous miscarriages will be recorded.	Timepoint 1 (between gestational weeks 9-14)
Other	Job status	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.	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	Tobacco use	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	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	Alcohol use	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.	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	Habitual physical activity	Habitual physical activity will be questioned using the following categories: regular (> 1x/week), occasional (=1x/week), never.	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	Subjective sleep quality with the Pittsburgh Sleep Quality Index (PSQI)	The PSQI assesses sleep quality over the past month: 19 items, global sleep quality scores range 0 - 21	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Other	Height	Height will be measured and reported in cm.	Timepoint 1 (between gestational weeks 9-14)
Other	Pre-pregnancy body weight	Pre-pregnancy body weight will be questioned and reported in kg.	Timepoint 1 (between gestational weeks 9-14)
Other	Number of falls during previous pregnancies	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?"	Timepoint 1 (between gestational weeks 9-14)
Other	Gestational week during which fall occurred during previous pregnancies	If the participant experienced a fall during a previous pregnancy, the gestational week during which the fall(s) occurred will be noted.	Timepoint 1 (between gestational weeks 9-14)
Other	Situation during which fall occurred during previous pregnancies	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.	Timepoint 1 (between gestational weeks 9-14)
Other	Injury severity of falls that occurred during previous pregnancies	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	Timepoint 1 (between gestational weeks 9-14)
Other	Urinary incontinence during previous pregnancies	The presence of urinary incontinence during previous pregnancies (yes/no), and the recovery of urinary incontinence postpartum (full, partial, no recovery) will be questioned.	Timepoint 1 (between gestational weeks 9-14)
Other	Participation in pre- and postnatal physiotherapy during previous pregnancies	Participation in pre- and postnatal physiotherapy during previous pregnancies (yes/no and types of interventions) will be questioned.	Timepoint 1 (between gestational weeks 9-14)
Other	Information on previous deliveries: child's birth weight	The birth weight of the previously born child will be noted in grams	Timepoint 1 (between gestational weeks 9-14)
Other	Information on previous deliveries: vaginal delivery or caesarean section	We will ask whether the previous deliveries were vaginal deliveries of caesarean sections.	Timepoint 1 (between gestational weeks 9-14)
Other	Information on previous deliveries: breastfeeding	We will ask whether the previous children received breastfeeding	Timepoint 1 (between gestational weeks 9-14)
Other	Number of falls during current pregnancy or in postpartum period	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?"	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	Timepoint during which fall occurred during current pregnancy or postpartum period	If the participant experienced a fall during or after the current pregnancy, the timepoint during which this fall occurred wil be noted.	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	Situation during which fall occurred during current pregnancy or postpartum period	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.	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	Injury severity of falls that occurred during current pregnancy or postpartum period	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	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	Urinary incontinence during current pregnancy	Urinary incontinence will be evaluated with the Pelvic Floor Distress Inventory (PFDI-20). The PFDI-20 contains 20 items, total score range 0 - 300	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)
Primary	Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester	The presence of PPGP will be questioned at each timepoint. PPGP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"	Timepoint 2 (between gestational weeks 34-38)
Primary	Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum	The presence of PPGP will be questioned at each timepoint. PPGP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"	Timepoint 3 (6 weeks postpartum)
Primary	Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum	The presence of PPGP will be questioned at each timepoint. PPGP will be defined as: "self-reported pain in the lumbar area, between the twelfth rib and the gluteal fold, with or without pain between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints that may radiate in the posterior thigh and could occur separately or in conjunction with pain in the symphysis pubis"	Timepoint 4 (6 months postpartum)
Primary	Postural control during first gestational trimester	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.	Timepoint 1 (between gestational weeks 9-14)
Primary	Postural control during third gestational trimester	Upright standing balance control will be measured as center-of-pressure displacements with a force plate.	Timepoint 2 (between gestational weeks 34-38)
Secondary	Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ)	The MDQ quantifies the extent of functional limitation in daily life due to low back pain: 10 items, total score range 0 - 100. Higher scores indicate higher levels of disability.	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS)	The QBPDS assesses disability in individuals with low back pain and PPGP: 20 items, total score range 0 - 100. Higher scores indicate higher levels of disability.	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS)	Pain intensity will be rated on the NPRS that ranges from 0 ("no pain") to 10 ("the worst pain imaginable").	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pain location of PPGP with a body chart	Individuals with PPGP will indicate the pain locations on a body chart.	Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Current body weight	Current body weight will be measured (kg)	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Current body composition	Current body composition will be measured with bioelectrical impedance analysis.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Proprioceptive use during postural control	Center-of-pressure displacements in response to ankle muscle and lower back muscle vibration (60 Hz, 15s) during upright standing will be measured with a force plate.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38)
Secondary	Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app)	During the laterality recognition task, participants view 40 pictures of a model that has its lower back bent or rotated to the left or the right side. They will be asked to judge the direction of movement as quickly and accurately as possible. Average speed (in seconds) of response time and average accuracy of the answers (in %) will be recorded.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Body perception at the lumbar spine will be assessed with the Fremantle Back Awareness Questionnaire (FreBAQ).	The FreBAQ assesses back-specific body perception: 9 items, total score range 0 - 45. Higher score indicate a more disturbed body perception.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK).	The TSK evaluates fear of movement and pain-related fear: 17 items, total score range 17 - 68. Higher scores indicate higher levels of pain-related fear of movement.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV).	During the PhoDA-SEV, participants view 40 pictures of daily life activities. They will be asked to imagine themselves performing the depicted activity and to indicate to which extent they believe that the activity is harmful to their back on a scale from 0 ("not harmful at all") to 100 ("extremely harmful"): 40 items, total score range 0 - 100. Higher scores indicate a higher perceived harmfulness of physical activities.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ)	The FABQ consists of 16 statements for which the participant rates her agreement with the statement on a scale from 0 ("completely disagree") to 6 ("completely agree"): 16 items, total score range 0 - 96). Higher scores indicate that poorer fear avoidance beliefs are held.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS)	The PCS contains 13 statements on thoughts and emotions possibly related to the experience of pain, for which the participants rates her agreement: 13 items, total score range 0 - 52. Higher scores indicate higher levels of pain catastrophizing.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pregnancy-related depression with the Edinburgh Depression Scale (EDS)	The EDS evaluates perinatal depression: 10 items, total score range 0 - 30. Higher scores indicate higher levels of pregnancy-related depression.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2)	The PRAQ-R2 evaluates pregnancy-related anxiety: 10 items, total score range 10 - 50. Higher scores indicate higher levels of pregnancy-related anxiety.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pregnancy-related stress with the Tilburg Pregnancy Distress Scale (TPDS).	The TPDS assesses pregnancy-related distress: 16 items, total score range 0 - 48). Higher scores indicate higher levels of pregnancy-related stress.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21)	The DASS-21 evaluates depressive mood, anxiety and stress in general: 21 items, total score per subscale (Depression, Stress, Anxiety) range 0 - 21. Higher scores indicate higher levels of depressive mood (DASS-21-Depression), anxiety (DASS-21-Anxiety) and stress (DASS-21-Stress).	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness) with the Leuven Affect Pleasure Scale (LAPS)	The LAPS comprehensively evaluates negative and positive affect, hedonic tone and independent variables (including cognitive and overall functioning, meaningful life and happiness): 16 items. It contains three subscores, which are calculated by adding the score on items 1-4 (Negative Affect), items 5-8 (Positive Affect) and items 9-12 (Hedonic Tone). Negative Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of negative affect. Positive Affect subscale: 4 items, score range 0 - 40, higher scores indicate higher levels of positive affect. Hedonic Tone subscale: 3 items, total score range 0 - 30, higher scores indicate higher levels of hedonic tone.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7)	The GAD-7 evaluates generalized anxiety: 7 items, total score range 0 - 21.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	The emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS).	The MAAS evaluates the emotional bond between mother and child antenatally, while the MPAS assesses this bond postnatally: 19 items, total score range 0 - 95	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Pain coping strategies with the Pain Coping Inventory (PCI)	The PCI evaluates whether one uses passive or active coping strategies: 34 items, total score range 0 - 100	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	Optimism and pessimism with the Life Orientation Test Revised (LOT-R)	The LOT-R contains 10 items: 3 evaluating optimism, 3 evaluating pessimism and 4 filler items, total score range on each subscale (optimism, pessimism) 0 - 12.	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)
Secondary	The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13)	The SOC-13 contains 13 items, total score ranges 0 - 91	Timepoint 1 (between gestational weeks 9-14), Timepoint 2 (between gestational weeks 34-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)