Exploring Central Sensitization in Pregnant Women
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorGöteborg University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
pregnant women at maternity care units and social media
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
central sensitization measured by Patient Pain Drawing
spreading of pain
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery2
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.
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliverySecondary outcomes
1
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.
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery2
Pelvic Girdle Questionnaire
Functioning. Minimum score 0 maximum score 100 where high scores mean worse outcome.
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery3
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
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery4
EuroQol 5-dimension questionnaire (EQ5D)
Health-related quality of life. Minimum score -0,59 and 1 maximum score where high scores mean better outcome
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliveryOther outcomes
1
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
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery2
subscale Catastrophizing (CSQ-CAT),from the Coping Strategies Questionnaire
Catastrophizing thoughts. Minimum score 0 maximum score 52 where high scores mean worse outcome
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after delivery3
General Self-Efficacy Scale
Self-efficacy. Minimum score 10 maximum score 40 where high scores mean better outcome
Time frame
change from baseline (gestational week 20-30) at 6 weeks, at 6 months and at 12 months after deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Göteborg University
Lead sponsor
Vastra Gotaland Region
Collaborator
Source ClinicalTrials.gov