Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain.

Официальное название

The Role of Proprioceptive, Fear-related and Inflammatory Factors in the Persistence of Pregnancy-related Lumbopelvic Pain in Pregnant Women.

Обзор

Pregnancy-related lumbopelvic pain (PLPP) affects 50-90% of pregnant women and is often dismissed as a normal part of pregnancy. However, the long-term consequences can be dramatic. Up to 21% of women with PLPP still have pain three years postpartum, and 10% experience disability, poorer quality of life, and lower ability to work 11 years after delivery. Because the multifactorial etiology of PLPP is unclear, prevention and treatment fall short. Previous studies on the causes of PLPP focused on impairments in motor output but ignored that impairments in sensory input (e.g., proprioception, the primary expertise of our research group) often precede motor output problems. Moreover, though psychological factors such as fear (of movement) are known to affect PLPP, their predictive role in PLPP remains understudied. Finally, the role of systemic inflammation in PLPP has yet to be examined, despite recent studies demonstrating its role in the chronification of lumbopelvic pain in the general population. This prospective cohort study aims to identify new modifiable predictors for the onset of PLPP during pregnancy and its persistence postpartum. The investigators will compare sensory (proprioception, body perception), fear-related, and inflammatory factors between women with and without PLPP and determine their predictive role in the onset and persistence of PLPP. The results will increase our understanding of the multifactorial etiology of PLPP and help optimize prevention and treatment.

Подробное описание

This study comprises a prospective cohort study with three objectives.

Objective 1 is to investigate whether the reliance on lumbar versus ankle proprioception during standing and body perception at the lower back (i.e., "proprioceptive factors"), anxiety, fear of movement, pain catastrophizing, depression, stress, and coping with stressful situations (i.e. "fear-related factors"), and inflammatory markers (i.e., "inflammatory factors") change over time and differ between women with and without PLPP in the 3rd pregnancy trimester, 6 weeks postpartum, and 9 months postpartum. We hypothesize that women with PLPP show (1a) a maladaptive reliance on ankle proprioception and/or disturbed body perception at the lower back, (1b) higher levels of fear of movement, anxiety, stress, depression, pain catastrophizing and poorer coping with stress, and (1c) greater immune activation and a disturbed balance of pro- vs. anti-inflammatory markers compared to pain-free women.

Objective 2 is to determine whether the proprioceptive, fear-related, and inflammatory factors are correlated in women with PLPP. Based on previous findings, we hypothesize that anxiety correlates with higher concentrations of IL-6 and IL-12, and lower concentrations of IL-2 and IL-10. We will also examine whether maladaptive reliance on ankle proprioception and disturbed body perception at the lower back correlate with fear of movement, anxiety, and concentrations of inflammatory markers in women with PLPP.

Objective 3 is to investigate whether the proprioceptive, fear-related, and inflammatory factors predict the presence of PLPP in the 3rd trimester, 6 weeks postpartum and 9 months postpartum. Based on previous research, we hypothesize that a maladaptive reliance on ankle proprioception and disturbed body perception at the lower back, higher levels of anxiety and fear of movement, and immune activation and disturbed balance of pro- and anti-inflammatory markers in the 1st trimester predict having PLPP in the 3rd trimester. We also expect that the presence of these factors in the 3rd trimester predicts the persistence of PLPP 6 weeks and 9 months postpartum.

Вмешательства

• Поведенческое Assessment of postural control, body perception, psychosocial factors and inflammation
  Behavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception, psychosocial factors (incl. fear of movement, pain catastrophizing, sense of coherence, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress) and inflammatory mediators.

Первичные конечные точки

• Pregnancy-related lumbopelvic pain (PLPP) (pregnant women) [Срок оценки: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Postural control (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Proprioceptive use during postural control (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Inflammation with blood samples (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Task-related fear of movement (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• The ability to cope in a stressful situation with the Sense of Coherence Scale (SOC-13) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Depression, anxiety and stress in general with the Depression Anxiety Stress Scale (DASS-21) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Pregnancy-related anxiety with the Revised Pregnancy-related Anxiety Questionnaire (PRAQ-R2) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36)]
• Pregnancy-related depression with the Edinburgh Depression Scale (EDS)(pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Catastrophic thinking related to pain with the Pain Catastrophizing Scale (PCS) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]

Вторичные конечные точки (10)

• Disability due to PLPP with the Modified Oswestry Disability Index (mODI) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Disability due to PLPP with the Quebec Back Pain Disability Scale (QBPDS) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Pain intensity of PLPP with Visual Analogue Scale (VAS) (pregnant women) [Срок оценки: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Pain frequency of PLPP (pregnant women) [Срок оценки: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Health-related quality of life with the 36-Item Short Form Health Survey (SF-36) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Fear avoidance beliefs with the Fear-Avoidance Beliefs Questionnaire (FABQ) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Pain location of PLPP with a body chart (pregnant women) [Срок оценки: Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Current body weight (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), Timepoint 4 (9 months postpartum)]
• Current fat mass (in kg) and fat-free mass (in kg) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), and Timepoint 4 (9 months postpartum)]
• Current total body water (in liter) (pregnant women) [Срок оценки: Timepoint 1 (between gestational weeks 9-16), Timepoint 2 (between gestational weeks 32-36), Timepoint 3 (6 weeks postpartum), and Timepoint 4 (9 months postpartum)]

Критерии участия

Критерии включения

• Informed consent to participate
• 18-40 years old
• Pregnant
• Singleton pregnancy (confirmed through ultrasound)
• No current PLPP
• Dutch- or English-speaking

Критерии исключения

• Pregnant for more than 16 weeks
• Currently experiencing PLPP, or having had PLPP during the index pregnancy
• History of surgery or major trauma to the spine or pelvis, major trauma or surgery to the lower limbs more than 2 years ago with current residual symptoms (e.g., pain, instability, stiffness), major trauma or surgery to the lower limbs less than 2 years ago
• Specific vestibular or balance disorders
• Use of medication that could affect balance (e.g., ototoxic or centrally-acting drugs)
• Having a medical diagnosis for, being treated by a rheumatologist for, or taking medication for a rheumatic condition
• (History of) a neurological disorder (e.g., neuropathy)
• Problems with vision that are not corrected by glasses, contact lenses or surgical eye correction
• Recent history of ankle problem (e.g., ankle sprain less than 3 weeks ago)
• Being on absolute/relative bed rest due to pregnancy complications
• (History of) inflammatory (e.g., gout, endometriosis), (auto)immune (e.g., lupus, ankylosis spondylitis, rheumatoid arthritis, psoriasis, Crohn's disease, Graves' disease, Hashimoto's thyroiditis, colitis ulcerosa, multiple sclerosis, etc.), hypothyroidism, or cancer.
• Having (had) a formal diagnosis of a psychiatric disorder (e.g., psychotic disorder).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 2 центра

• Hasselt University — Hasselt
• KU Leuven — Leuven

Идентификаторы

NCT: NCT06785909 · S69463

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗