WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

Not Applicable

Recruiting

• Conditions: Physical Activity; Pelvic Girdle Pain

• Registration Number: NCT07158957
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-19
• Status Verified: 2024-10
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 592

Inclusion Criteria

• pregnant women with or without pelvic girdle pain

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical activity: the Pregnancy Physical Activity Questionnaire	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	different domains of physical activity in every day life
Health by EQ5D	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Health-related quality of life by the EuroQol 5-dimension questionnaire.
Function, summary of sensory components of pain	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	SENSORY component of pain: Severity and disability of Pelvic Girdle Pain - measured by the Pelvic Girdle Questionnaire (PGQ).
Function, summary of cognitive components of pain	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	COGNITIVE component of pain: Self-efficacy for carrying out physical activity - measured by the Pregnancy-Exercise Self-Efficacy Scale (P-ESES).
Function, summary of emotional components of pain	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	EMOTIONAL component of pain: Concern about pain - a Numeric Rating Scale of 0-10.

Secondary Outcome Measures

Name	Time	Method
Evening pain	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Evening pain intensity at its worst, measured by a NRS where 10 = worst pain
Pain frequency	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Pain frequency by question
Depressive symptoms	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Symptoms of depression, measured by the Edinburgh Postnatal Depression Scale
Person-centered function	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	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
Prevalence of pelvic girdle pain	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Prevalence of Pelvic Girdle Pain measured with self-administered pelvic pain provocation tests.
Work ability	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Work ability, measured by one question from the Work Ability Index.
health economy	From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth	Health-economy evaluation with direct/indirect costs (days on sick leave, visits to health care providers).

Trial Locations

Locations (2)

Närhälsan Gibraltargatan rehabmottagning; 🇸🇪 Gothenburg, Sweden

Närhälsan Eriksberg rehabmottagning; 🇸🇪 Gothenburg, Sweden