Exploring Central Sensitization in Pregnant Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Pelvic Girdle Pain, Chronic Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central sensitization measured by Patient Pain Drawing | spreading of pain | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| central sensitization measured by conditioned pain modulation using an algometer and a occlusion cuff | malfunctioning of descending nociceptive inhibitory pathways | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Physical Activity Questionnaire | Physical activity and exercise are measured by this self-administered questionnaire which provides assessment of four domains of physical activity; ''Sports and Exercises', ''Household and Caregiving'', 'Transportation''and ''Occupation'. Since it measures the frequency and the duration of the activities, (an intensity value assigned to each activity), the minimum values are 0 but here are no maximum values. The activities can be analyzed by type, by intensity or for the total energy expenditure. | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| Pelvic Girdle Questionnaire | Functioning. Minimum score 0 maximum score 100 where high scores mean worse outcome. | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| Patients Specific Functioning Scale | Two by the participant, self-chosen activities rated on a numeric rating scale. Minimum score 0 maximum score 10 where high scores mean better outcome | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| EuroQol 5-dimension questionnaire (EQ5D) | Health-related quality of life. Minimum score -0,59 and 1 maximum score where high scores mean better outcome | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| Work Ability Index | Current work ability marked on a Numeric Rating Scale. Minimum score 0 maximum score 10 where high scores mean better outcome | change from baseline (gestational week 20-30),at 12 months after delivery, | 
| Numeric Rating Scale for pain | pain intensity. Minimum score 0 maximum score 10 where high scores mean worse outcome | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| Numeric Rating Scale for concern | Concern. Minimum score 0 maximum score 10 where high scores mean worse outcome | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery | 
| Edinburgh Postnatal Depression Scale | Symptoms of depression. Minimum score 0 maximum score 30 where high scores mean worse outcome | change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery |