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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05507853
Enrollment
144
Registered
2022-08-19
Start date
2023-08-15
Completion date
2025-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Pelvic Girdle Pain

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.

Interventions

None listed

Sponsors

Vastra Gotaland Region
CollaboratorOTHER_GOV
Göteborg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
central sensitization measured by Patient Pain Drawingchange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryspreading of pain
central sensitization measured by conditioned pain modulation using an algometer and a occlusion cuffchange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryMalfunctioning 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.

Secondary

MeasureTime frameDescription
Pelvic Girdle Questionnairechange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryFunctioning. Minimum score 0 maximum score 100 where high scores mean worse outcome.
Patients Specific Functioning Scalechange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryTwo by the participant, self-chosen activities rated on a numeric rating scale. Minimum score 0 maximum score 10 where high scores mean better outcome
EuroQol 5-dimension questionnaire (EQ5D)change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryHealth-related quality of life. Minimum score -0,59 and 1 maximum score where high scores mean better outcome
Pregnancy Physical Activity Questionnairechange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryPhysical 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.
Numeric Rating Scale for painchange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliverypain intensity. Minimum score 0 maximum score 10 where high scores mean worse outcome
Numeric Rating Scale for concernchange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryConcern. Minimum score 0 maximum score 10 where high scores mean worse outcome
Edinburgh Postnatal Depression Scalechange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliverySymptoms of depression. Minimum score 0 maximum score 30 where high scores mean worse outcome
Work Ability Indexchange from baseline (gestational week 20-30),at 12 months after delivery,Current work ability marked on a Numeric Rating Scale. Minimum score 0 maximum score 10 where high scores mean better outcome

Other

MeasureTime frameDescription
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 deliveryFear avoidance beliefs about physical activity. Minimum score 0 maximum score 24 where high scores mean worse outcome
General Self-Efficacy Scalechange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliverySelf-efficacy. Minimum score 10 maximum score 40 where high scores mean better outcome
subscale Catastrophizing (CSQ-CAT),from the Coping Strategies Questionnairechange from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryCatastrophizing thoughts. Minimum score 0 maximum score 52 where high scores mean worse outcome

Countries

Sweden

Contacts

Primary ContactAnnelie Gutke, associate professor
annelie.gutke@gu.se0046(0)7665747
Backup ContactSonia Coelho Cristovao, PhD-student

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026