Exploring Central Sensitization in Pregnant Women

NCT05507853 | Recruiting

• 1 other identifier: VGFOUREG-939632
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Girdle Pain; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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)= 1. 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 ) 2. 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 Outcomes (8)

• Pregnancy Physical Activity Questionnaire

  change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

• Pelvic Girdle Questionnaire

  change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

• Patients Specific Functioning Scale

  change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

• EuroQol 5-dimension questionnaire (EQ5D)

  change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

• Work Ability Index

  change from baseline (gestational week 20-30),at 12 months after delivery,

Other Outcomes (3)

• 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

• 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

• General Self-Efficacy Scale

  change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women at maternity care units and social media

You may qualify if:

• pregnant (first time pregnant or previous experience of pregnancy)
• years of age or older
• have a single foetus pregnancy
• be in gestational weeks 20-30
• able to read and understand Swedish or English

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead
• Vastra Gotaland Region: collaborator

Study Sites (1)

Närhälsan Gibraltargatan

Gothenburg, 43654, Sweden

RECRUITING

MeSH Terms

Conditions

Pelvic Girdle Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Central Study Contacts

Annelie Gutke, associate professor

CONTACT

0046(0)7665747; annelie.gutke@gu.se

Sonia Coelho Cristovao, PhD-student

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: August 19, 2022
• Study Start: August 15, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

SE (1)