Low Back Pain Disability, Intensity and Widespread Pain and Relationship to Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- Post-Partum Depression
研究概览
简要总结
The aims of this study are to investigate whether pelvic pain and low back pain disability are associated with postpartum depression and to compare the prevalence between women without Low back pain and disability and women with Low Back Pain (LBP) and disability every trimester, and correlate postpartum Depression and some clinical and biopsychosocial variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in a cohort of Spanish women at 2 months postpartum.
详细描述
295 pregnant women will formed the cohort, during all pregnancy and two months after delivery. The Edinburgh Postnatal Depression Scale was used to evaluate depressive symptoms at 2 months postpartum. The LBP will be evaluated based on self-administrated questionnaire, and the patients with LBP will be classified in to lumbopelvic groups according to mechanical assessment of the lumbar spine, pelvic pain provocation tests, standard history, pain intensity on visual analogue scale, spread of pain through pain drawings and Oswestry index was used to evaluated the disability. Logistics regression analysis will performed to explain the predictors of depression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria were being pregnant between for 12 weeks to 16 weeks,
- •With an expected normal pregnancy (as determined by midwife),
- •Being able to understand and read Spanish.
排除标准
- •Exclusion criteria were end of pregnancy before gestational weeks 37 (delivery or abortion),
- •Serious intellectual impairment,
- •Having had a systemic disease (spondylitis, infectious, vascular, metabolic or endocrine related process), rheumatic disease, fibromyalgia, lumbopelvic pain or
- •Verified diagnosis of spinal problems in the previous 6 months, or
- •A history of fracture, neoplasm or previous spinal, pelvic or femur surgery.
- •Another exclusion criterion was a diagnosis of depression or anxiety in the previous year.
结局指标
主要结局
Post-Partum Depression
时间窗: change from baseline in postpartum depression at 2 months after delivery
Depressive Symptoms is assessed through the Edinburgh Postnatal Depression Scale (EPDS) (translation - Spanish). It´s a 10-item self-report scale specifically designed to screen for postpartum depression. The scale rates the intensity of depressive symptoms present within the previous 7 days. A cutoff score of ≥10 in the tests is to be used for screening purposes in primary care. When selecting this threshold the sensitivity for detection of major depression increased to almost 100% and the specificity to 82%. The participants filled it in at the first visit and two months postpartum.
次要结局
- Pain Scores in the visual analogue scale(Participants will be followed for the duration of pregnant up to 36 weeks)
- Low back pain disability(Participants will be followed for the duration of pregnant up to 36 weeks)
- Pain drawing area(Participants will be followed for the duration of pregnant up to 36 weeks)
研究者
Josue Fernandez Carnero
PhD, Associate Professor
Universidad Rey Juan Carlos