The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Multiparous Women:
- •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
排除标准
- •Multiparous Women:
- •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
- •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
- •Inclusion Criteria Nulliparous Women:
- •Age- and BMI- matched to pregnant participants
- •Nulliparous
- •Willing to provide written informed consent
- •Exclusion Criteria Nulliparous Women:
- •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
研究组 & 干预措施
Multiparous, pregnant women
Multiparous women are followed over time and measurements are performed during the first and third pregnancy trimester, and six weeks and six months postpartum.
干预措施: Assessment of postural control, body perception, psychosocial factors and inflammation (Behavioral)
Nulliparous women
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.
干预措施: Assessment of postural control, body perception, psychosocial factors and inflammation (Behavioral)
结局指标
主要结局
Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Current body weight (nulliparous women)(Timepoint 1 (within 2 weeks after inclusion))
- Pain intensity of PPGP with Numerical Pain Rating Scale (NPRS) (multiparous women)(Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum))
- Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women)(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)(Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum))
- Current body weight (multiparous women)(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 composition (multiparous women)(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)(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) (nulliparous women)(Timepoint 1 (within 2 weeks after inclusion))
- Pain coping strategies with the Pain Coping Inventory (PCI) (nulliparous women)(Timepoint 1 (within 2 weeks after inclusion))
- Proprioceptive use during postural control (multiparous women)(Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38))
- Pain-related fear of movement with the Tampa Scale for Kinesiophobia (TSK) (multiparous women)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Pregnancy-related depression with the Edinburgh Depression Scale (EDS) (multiparous women)(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)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Proprioceptive use during postural control (nulliparous women)(Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1))
- Perceived harmfulness of specific physical activities with the Photograph Series of Daily Activities - Short Electronic Version (PhoDA-SEV) (multiparous women)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (multiparous women)(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)(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)(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) (multiparous women)(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) (multiparous women)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Body perception at the lumbar spine will be assessed with a laterality recognition task ("Recognise Back" app) (nulliparous women)(Timepoint 1 (within 2 weeks after inclusion), 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)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (multiparous women)(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)(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)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Generalized anxiety with the 7-item Generalized Anxiety Disorders scale (GAD-7) (multiparous women)(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 emotional bond between mother and child with the Maternal Antenatal/Postpartum Attachment Scale (MAAS/MPAS).(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)(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) (multiparous women)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Pain frequency of PPGP (multiparous women)(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)(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)(Timepoint 1 (within 2 weeks after inclusion))
- Inflammation with blood samples (multiparous women)(Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum))
研究者
Lotte Janssens
Professor
Hasselt University