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

Официальное название

The Role of Lumbar Proprioceptive Deficits, Psychosocial Factors and Inflammation in Pregnancy-related Pelvic Girdle Pain: a Follow-up Study in Multiparous Pregnant Women

Обзор

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.

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. 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

Первичные конечные точки

• Pregnancy-related low back and/or pelvic girdle pain (PPGP) during third gestational trimester (multiparous women) [Срок оценки: Timepoint 2 (between gestational weeks 32-38)]
• Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six weeks postpartum (multiparous women) [Срок оценки: Timepoint 3 (6 weeks postpartum)]
• Pregnancy-related low back and/or pelvic girdle pain (PPGP) at six months postpartum (multiparous women) [Срок оценки: Timepoint 4 (6 months postpartum)]
• Postural control during first gestational trimester (multiparous women) [Срок оценки: Timepoint 1 (before gestational week 16)]
• Postural control during third gestational trimester (multiparous women) [Срок оценки: Timepoint 2 (between gestational weeks 32-38)]
• Postural control (nulliparous women) [Срок оценки: Timepoint 1 (within 2 weeks after inclusion), (Timepoint 2 (1 - 2 weeks after Timepoint 1))]

Вторичные конечные точки (12)

• Disability due to PPGP with the Modified Low Back Pain Disability Questionnaire (MDQ) (multiparous women) [Срок оценки: 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) [Срок оценки: Timepoint 1 (within 2 weeks after inclusion)]
• Disability due to PPGP with the Quebec Back Pain Disability Scale (QBPDS) (multiparous women) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Timepoint 2 (between gestational weeks 32-38), Timepoint 3 (6 weeks postpartum) and Timepoint 4 (6 months postpartum)]
• Current body weight (multiparous women) [Срок оценки: 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) [Срок оценки: Timepoint 1 (within 2 weeks after inclusion)]
• Current body composition (multiparous women) [Срок оценки: 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) [Срок оценки: Timepoint 1 (before gestational week 16), Timepoint 2 (between gestational weeks 32-38)]
• Proprioceptive use during postural control (nulliparous women) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Timepoint 1 (within 2 weeks after inclusion), Timepoint 2 (1-2 weeks after Timepoint 1)]

Критерии участия

Inclusion Criteria 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

Exclusion Criteria 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

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Бельгия · 1 центр

• Hasselt University — Hasselt

Идентификаторы

NCT: NCT04226716 · CME ZOL - CTU2019085

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗