Exploring Central Sensitization in Pregnant Women
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- central sensitization measured by Patient Pain Drawing [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 [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
Secondary Outcome Measures
- Pregnancy Physical Activity Questionnaire [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
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.
- Pelvic Girdle Questionnaire [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Functioning. Minimum score 0 maximum score 100 where high scores mean worse outcome.
- Patients Specific Functioning Scale [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
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
- EuroQol 5-dimension questionnaire (EQ5D) [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Health-related quality of life. Minimum score -0,59 and 1 maximum score where high scores mean better outcome
- Work Ability Index [change from baseline (gestational week 20-30),at 12 months after delivery,]
Current work ability marked on a Numeric Rating Scale. Minimum score 0 maximum score 10 where high scores mean better outcome
- Numeric Rating Scale for pain [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
pain intensity. Minimum score 0 maximum score 10 where high scores mean worse outcome
- Numeric Rating Scale for concern [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Concern. Minimum score 0 maximum score 10 where high scores mean worse outcome
- Edinburgh Postnatal Depression Scale [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Symptoms of depression. Minimum score 0 maximum score 30 where high scores mean worse outcome
Other Outcome Measures
- Fear-Avoidance Beliefs Questionnaire subscale on physical activity (FABQ-PA) [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Fear avoidance beliefs about physical activity. Minimum score 0 maximum score 24 where high scores mean worse outcome
- subscale Catastrophizing (CSQ-CAT),from the Coping Strategies Questionnaire [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Catastrophizing thoughts. Minimum score 0 maximum score 52 where high scores mean worse outcome
- General Self-Efficacy Scale [change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Self-efficacy. Minimum score 10 maximum score 40 where high scores mean better outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
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pregnant (first time pregnant or previous experience of pregnancy)
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18 years of age or older
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have a single foetus pregnancy
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be in gestational weeks 20-30
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able to read and understand Swedish or English
Exclusion Criteria:
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no history of a fracture or malignant disease in the back, pelvis, pelvic floor or hips
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no systemic disease of the musculoskeletal or the nervous system
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no diseases such as gestational diabetes or diabetes type 1 and 2, hypertension
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no obstetric complications
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no contradiction for tests.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Göteborg University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VGFOUREG-939632