Exploring Central Sensitization in Pregnant Women

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Pelvic Girdle 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.

• Study Type: Observational
• Enrollment (Estimated): 144

Contacts and Locations

• Study Contact: Name: Annelie Gutke, associate professor; Phone Number: 0046(0)7665747; Email: annelie.gutke@gu.se
• Study Contact Backup: Name: Sonia Coelho Cristovao, PhD-student

Study Locations

• Sweden
  • Göteborg, Sweden, 43654
    • Recruiting
    • Närhälsan Gibraltargatan
    • Contact: Annelie Gutke; Phone Number: 0766-185747; Email: annelie.gutke@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

pregnant women at maternity care units and social media

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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 resulting in dysfunctional endogenous analgesia, assessed by a conditioned pain modulation (CPM)=; PressurePainThresholds (PPT)is assed by a digital algometer at symtomatic (sacrum and lumbar paravertebral muscles and 2 remote locations)+at asymptomatic regions(web thumb-index, prox 1/3 calf ); mechanism of CPM will be induced by inflating an occlusion cuff (conditioning stimulus) at the participant's left arm to a painful intensity. The occlusion cuff is inflated until 'the first sensation of pain' is reported. This cuff inflation is maintained for 30 sec. The participant is than asked to rate the pain intensity, as a result of cuff inflation at the left arm, on a NRS (0=no pain-10=worst pain). Next, the cuff inflation is increased or decreased until pain intensity at the left arm was rated as 3/10 on NRS. The PPT assessments are then repeated during maintenance of the cuff inflation and relaxation of the left arm.	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Göteborg University
• Collaborators: Vastra Gotaland Region

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Chronic Pain; Pelvic Girdle Pain
• Other Study ID Numbers: VGFOUREG-939632

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No