Exploring Central Sensitization in Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pelvic Girdle Pain, Chronic Pain. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
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.
Primary outcome measures
- central sensitization measured by Patient Pain Drawing [Time frame: 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 [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Secondary outcome measures (8)
- Pregnancy Physical Activity Questionnaire [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
- Pelvic Girdle Questionnaire [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
- Patients Specific Functioning Scale [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
- EuroQol 5-dimension questionnaire (EQ5D) [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
- Work Ability Index [Time frame: change from baseline (gestational week 20-30),at 12 months after delivery,]
- Numeric Rating Scale for pain [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
- Numeric Rating Scale for concern [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
- Edinburgh Postnatal Depression Scale [Time frame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Närhälsan Gibraltargatan — Gothenburg
Identifiers
NCT: NCT05507853 · VGFOUREG-939632