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NCT Number: NCT07158957

WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

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.

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Key information

Conditions

Pelvic Girdle Pain Behavior Motor Activity Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Physical Activity Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Närhälsan Eriksberg rehabmottagning, Gothenburg, Sweden

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Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Knowledge

Other

-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

Other names: individual clinical physiotherapy

motivation for behavioral change

Behavioral

motivation to be physically active

Primary outcomes

  1. Physical activity: the Pregnancy Physical Activity Questionnaire

    Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth

    different domains of physical activity in every day life

  2. Health by EQ5D

    Time frame: 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.

  3. Function, summary of sensory components of pain

    Time frame: 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).

  4. Function, summary of cognitive components of pain

    Time frame: 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).

  5. Function, summary of emotional components of pain

    Time frame: 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 outcomes

  1. Person-centered function

    Time frame: 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

  2. Prevalence of pelvic girdle pain

    Time frame: 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.

  3. Work ability

    Time frame: 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.

  4. Evening pain

    Time frame: 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

  5. Pain frequency

    Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth

    Pain frequency by question

  6. Depressive symptoms

    Time frame: 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

  7. health economy

    Time frame: 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).

Other outcomes

  1. Fear avoidance belief

    Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth

    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.

  2. Catastrophizing thoughts

    Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth

    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)

Study contacts

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

Annelie Gutke, associate professor

CONTACT

[email protected]

0766185747

Bodil Halvarsson, PhD-student

CONTACT

[email protected]

+46(0)73-0651911

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Göteborg University

Registry information

Official study title

WOMENinMOTION An Intervention Model for Pelvic Girdle Pain to Acquire Health-promoting Habits in Pregnancy and Prevent Chronic Pain in Women

Acronym: WIMPGP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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