In the Joints or in the Brain? Exploring Central Sensitization in Pregnant Women and Its Role in Pain, Physical Activity, Functioning and Health Following Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- central sensitization measured by Patient Pain Drawing
研究概览
简要总结
Pelvic Girdle Pain (PGP) is reported by 50% of pregnant women and up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP. Central (nervous system) sensitization that elicits pain hypersensitivity, may be one explanation.
The overall aim of this study is to explore features of central sensitization in pregnant women and its predictive ability on physical activity, functioning and health in women with PGP. Measurements of central sensitization will be done on two study groups, pregnant women with PGP and healthy controls. To identify women at risk to develop chronic pain in relation to a common pain experience ie PGP in pregnancy, may help us understand if central sensitization early in life explains why women develop chronic pain.
详细描述
Pelvic Girdle Pain (PGP) is reported by 50% (60000) of pregnant women yearly in Sweden. PGP is expected to disappear after delivery. However up to 11 years after pregnancy, 10% of women have persistent and per definition chronic PGP with large impact on their physical activity, functioning,and health. Central (nervous system) sensitization, defined as an amplification of neural signaling within the central nervous system that elicits pain hypersensitivity, may be one explanation why 10% of women develop postpartum chronic PGP and related physical inactivity.
The overall aim of this study is to explore features of central sensitization in pregnant women and its predictive ability on physical activity, functioning and health in women with PGP. Two study groups, pregnant women with PGP and healthy controls (including non-native Swedish) will be included through maternity care units and a blog. Measurements of primary outcome central sensitization will be done. To identify women at risk to develop chronic pain in relation to a common pain experience ie PGP in pregnancy, may help us understand if central sensitization early in life explains why women develop chronic pain.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant (first time pregnant or previous experience of pregnancy)
- •18 years of age or older
- •have a single foetus pregnancy
- •be in gestational weeks 20-30
- •able to read and understand Swedish or English
排除标准
- •no history of a fracture or malignant disease in the back, pelvis, pelvic floor or hips
- •no systemic disease of the musculoskeletal or the nervous system
- •no diseases such as gestational diabetes or diabetes type 1 and 2, hypertension
- •no obstetric complications
- •no contradiction for tests.
结局指标
主要结局
central sensitization measured by Patient Pain Drawing
时间窗: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
spreading of pain
central sensitization measured by conditioned pain modulation using an algometer and a occlusion cuff
时间窗: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
Malfunctioning of descending nociceptive inhibitory pathways resulting in dysfunctional endogenous analgesia, assessed by a conditioned pain modulation (CPM)= 1. PressurePainThresholds (PPT)is assed by a digital algometer at symtomatic (sacrum and lumbar paravertebral muscles and 2 remote locations)+at asymptomatic regions(web thumb-index, prox 1/3 calf ) 2. mechanism of CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the participant's left arm to a painful intensity. The occlusion cuff is inflated until 'the first sensation of pain' is reported. This cuff inflation is maintained for 30 sec. The participant is than asked to rate the pain intensity, as a result of cuff inflation at the left arm, on a NRS (0=no pain-10=worst pain). Next, the cuff inflation is increased or decreased until pain intensity at the left arm was rated as 3/10 on NRS. The PPT assessments are then repeated during maintenance of the cuff inflation and relaxation of the left arm.
次要结局
- Edinburgh Postnatal Depression Scale(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)
- Pregnancy Physical Activity Questionnaire(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)
- Numeric Rating Scale for pain(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)
- Pelvic Girdle Questionnaire(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)
- Patients Specific Functioning Scale(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)
- EuroQol 5-dimension questionnaire (EQ5D)(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)
- Work Ability Index(change from baseline (gestational week 20-30),at 12 months after delivery,)
- Numeric Rating Scale for concern(change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery)