Exploring Central Sensitization in Pregnant Women

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05507853
• Other study ID #: VGFOUREG-939632
• Status: Not yet recruiting
• Start date: October 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pelvic Girdle Pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fear-Avoidance Beliefs Questionnaire subscale on physical activity (FABQ-PA)	Fear avoidance beliefs about physical activity. Minimum score 0 maximum score 24 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
Other	subscale Catastrophizing (CSQ-CAT),from the Coping Strategies Questionnaire	Catastrophizing thoughts. Minimum score 0 maximum score 52 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
Other	General Self-Efficacy Scale	Self-efficacy. Minimum score 10 maximum score 40 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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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,
Secondary	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
Secondary	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
Secondary	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