WOMENinMOTION An Intervention Model for Pelvic Girdle Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorVastra Gotaland Region
About this trial
The overall aim is to educate women to handle common pregnancy-related pain experiences to facilitate healthy life-long physical activity habits and prevent chronic pain.
Our developed WOMENinMOTION model with person-centred preventions and interventions focused on management of pain components added to usual care, will be evaluated in a randomized control study against usual care.
Data and method The model WOMENinMOTION is built on pain education and management of the sensory, emotional, and cognitive components of pain. Through pain management and motivation, pregnant women are guided to choose personal tools for health-promoting physical activity and adaptation of daily activities. Instructive films of exercises, pelvic belt application, and knowledge to meet worries are provided digitally. When the digital content is insufficient, the model is supported by physiotherapist.
Plan for project realisation WOMENinMOTION developed in collaboration with women with PGP, will be pilot tested including analysis of focus groups interviews 2024. The model is evaluated by self-reported questionnaires in a multicenter randomised controlled trial 2025-27 with primary outcomes: physical activity, function and health in gestational week 35, 4 months, 1 and 2 years after birth. Secondary outcomes is PGP prevalence, satisfaction with care, and health economy.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
pregnant women with or without pelvic girdle pain
Disqualifiers
previous fracture, malignancy or surgical interventions (pelvic floor, spine, pelvis, or hip) or disease of musculoskeletal-or nervous system
serious intercurrent diseases such as diabetes and high blood pressure.
multiple pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
knowledge
Other intervention-knowledge on pain in general and specifically pelvic girdle pain Pregnant women who in addition to usual care get our model WOMENinMOTION on a digital platform with self-directed content areas modules and linked tasks to promote physical activity and function by reducing concerns, pain, and building confidence for physical activity and realistic expectations. When women consider the digital platform insufficient, they are referred to physiotherapy at clinic for physiotherapeutically individually coached content of WIM
motivation for behavioral change
Behavioralmotivation to be physically active
Treatment groups
592 Participants
are divided into 2 treatment groupsGroup A: usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))Experimental treatment 2 interventions
Group B: usual maternity health careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Physical activity: the Pregnancy Physical Activity Questionnaire
different domains of physical activity in every day life
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth2
Health by EQ5D
Health-related quality of life by the EuroQol 5-dimension questionnaire.
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth3
Function, summary of sensory components of pain
SENSORY component of pain: Severity and disability of Pelvic Girdle Pain - measured by the Pelvic Girdle Questionnaire (PGQ).
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth4
Function, summary of cognitive components of pain
COGNITIVE component of pain: Self-efficacy for carrying out physical activity - measured by the Pregnancy-Exercise Self-Efficacy Scale (P-ESES).
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthSecondary outcomes
1
Person-centered function
Person-centered function, assessed by the Patients Specific Function Scale (PSFS). Two, by the participant, self-chosen activities rated on a numeric rating scale of 0-10; 10 = have full function
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth2
Prevalence of pelvic girdle pain
Prevalence of Pelvic Girdle Pain measured with self-administered pelvic pain provocation tests.
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth3
Work ability
Work ability, measured by one question from the Work Ability Index.
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth4
Evening pain
Evening pain intensity at its worst, measured by a NRS where 10 = worst pain
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthOther outcomes
1
Fear avoidance belief
Fear avoidance beliefs questionnaire subscale that measures physical activity (FABQ-PA). Zero is equivalent to no fear avoidance and 24 indicates the highest possible fear avoidance.
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth2
Catastrophizing thoughts
Using- Pain Catastrophizing Scale, ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 (no catastrophizing thoughts) to 52 (highest possible catastrophizing thoughts)
Time frame
From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Vastra Gotaland Region
Lead sponsor
Göteborg University
Collaborator
Source ClinicalTrials.gov