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NCT Number: NCT05507853

Exploring Central Sensitization in Pregnant Women

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.

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Key information

Conditions

Pelvic Girdle Pain Chronic Pain Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Närhälsan Gibraltargatan

Gothenburg, 43654, Sweden

Location status: Recruiting

Location contact

Annelie Gutke

CONTACT

[email protected]

0766-185747

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. central sensitization measured by Patient Pain Drawing

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

    spreading of pain

  2. central sensitization measured by conditioned pain modulation using an algometer and a occlusion cuff

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

    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.

Secondary outcomes

  1. Pregnancy Physical Activity Questionnaire

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

    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.

  2. Pelvic Girdle Questionnaire

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

    Functioning. Minimum score 0 maximum score 100 where high scores mean worse outcome.

  3. Patients Specific Functioning Scale

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

    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

  4. EuroQol 5-dimension questionnaire (EQ5D)

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

    Health-related quality of life. Minimum score -0,59 and 1 maximum score where high scores mean better outcome

  5. Work Ability Index

    Time frame: change 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

  6. Numeric Rating Scale for pain

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

    pain intensity. Minimum score 0 maximum score 10 where high scores mean worse outcome

  7. Numeric Rating Scale for concern

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

    Concern. Minimum score 0 maximum score 10 where high scores mean worse outcome

  8. Edinburgh Postnatal Depression Scale

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

    Symptoms of depression. Minimum score 0 maximum score 30 where high scores mean worse outcome

Other outcomes

  1. Fear-Avoidance Beliefs Questionnaire subscale on physical activity (FABQ-PA)

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

    Fear avoidance beliefs about physical activity. Minimum score 0 maximum score 24 where high scores mean worse outcome

  2. subscale Catastrophizing (CSQ-CAT),from the Coping Strategies Questionnaire

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

    Catastrophizing thoughts. Minimum score 0 maximum score 52 where high scores mean worse outcome

  3. General Self-Efficacy Scale

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

    Self-efficacy. Minimum score 10 maximum score 40 where high scores mean better outcome

Study contacts

Contact information is provided by the study sponsor or research team.

Annelie Gutke, associate professor

CONTACT

[email protected]

0046(0)7665747

Sonia Coelho Cristovao, PhD-student

CONTACT

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Collaborators

  • Vastra Gotaland Region

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2022
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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