WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

NCT ID: NCT07158957

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-19

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Pelvic Girdle Pain Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))

pregnant women who in addition to usual care get our model WOMENinMOTION (WIM) on a digital platform. When needed, referred to physiotherapy at clinic for WIM

Group Type EXPERIMENTAL

knowledge

Intervention Type 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

motivation for behavioral change

Intervention Type BEHAVIORAL

motivation to be physically active

usual maternity health care

usual maternity health care according to regional guidelines including general advice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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knowledge

-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

Intervention Type OTHER

motivation for behavioral change

motivation to be physically active

Intervention Type BEHAVIORAL

Other Intervention Names

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individual clinical physiotherapy

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Annelie Gutke, PhD, associate professor

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Närhälsan Gibraltargatan rehabmottagning

Gothenburg, , Sweden

Site Status RECRUITING

Närhälsan Eriksberg rehabmottagning

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Annelie Gutke, associate professor

Role: CONTACT

0766185747

Bodil Halvarsson, PhD-student

Role: CONTACT

+46(0)73-0651911

Facility Contacts

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Annelie Gutke, RPT, PhD

Role: primary

0768986007

Annelie Gutke, RPT, PhD

Role: primary

0768986007

PhD student

Role: backup

0768986007 ext. +46(0)73065191

Other Identifiers

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2022-00146

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VGRINN-979977

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

VGRINN-993309

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Västra Götaland_WIMPGP

Identifier Type: -

Identifier Source: org_study_id

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