About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Assessment of postural control, body perception, psychosocial factors and inflammation
Behavioral
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

Treatment groups

192 Participants

are divided into 2 treatment groups

Group A: Multiparous, pregnant womenOther 1 intervention

Group B: Nulliparous womenOther 1 intervention

Trial outcomes

Primary outcomes

1

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"

Time frame

Timepoint 2 (between gestational weeks 32-38)

2

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"

Time frame

Timepoint 3 (6 weeks postpartum)

3

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"

Time frame

Timepoint 4 (6 months postpartum)

4

Postural control during first gestational trimester (multiparous women)

Upright standing balance control will be measured as center-of-pressure displacements with a force plate.

Time frame

Timepoint 1 (before gestational week 16)

Secondary outcomes

1

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.

Time frame

Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

2

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.

Time frame

Timepoint 1 (within 2 weeks after inclusion)

3

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.

Time frame

Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

4

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").

Time frame

Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

Other outcomes

1

Diagnostic clinical tests for PPGP (multiparous women)

The following pain provocation tests for PPGP will be performed: thigh thrust and trendelenburg test. 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 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

2

Ability to transfer load between the spine and the legs via the pelvis with active straight leg raise test (ASLR) (multiparous women)

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 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)

3

Sociodemographic information: age (multiparous women)

The age of the participant will be noted (in years)

Time frame

Timepoint 1 (before gestational week 16)

4

Sociodemographic information: age (nulliparous women)

The age of the participant will be noted (in years)

Time frame

Timepoint 1 (within 2 weeks after inclusion)

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts