Clinical trial NCT05507853: Exploring Central Sensitization in Pregnant Women
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pelvic Girdle Pain
Chronic Pain
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2022-08-19
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women at maternity care units and social media

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.

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.

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.

Primary outcomes:
measure: central sensitization measured by Patient Pain Drawing
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: central sensitization measured by conditioned pain modulation using an algometer and a occlusion cuff
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
Secondary outcomes:
measure: Pregnancy Physical Activity Questionnaire
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: Pelvic Girdle Questionnaire
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: Patients Specific Functioning Scale
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: EuroQol 5-dimension questionnaire (EQ5D)
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: Work Ability Index
timeFrame: change from baseline (gestational week 20-30),at 12 months after delivery,
measure: Numeric Rating Scale for pain
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: Numeric Rating Scale for concern
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: Edinburgh Postnatal Depression Scale
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
Other outcomes:
measure: Fear-Avoidance Beliefs Questionnaire subscale on physical activity (FABQ-PA)
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: subscale Catastrophizing (CSQ-CAT),from the Coping Strategies Questionnaire
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
measure: General Self-Efficacy Scale
timeFrame: change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery
Locations:
city: Göteborg
country: Sweden
facility: Närhälsan Gibraltargatan
Study officials:
References: