Pelvic Girdle PainWIMPGPNCT07158957
WOMENinMOTION An Intervention Model for Pelvic Girdle Pain
A study testing knowledge and motivation for behavioral change in people with Pelvic Girdle Pain and Physical Activity, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain, Physical Activity
- What is being tested?
- knowledge and motivation for behavioral change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 2 sitesSweden
- Study dates
- 19 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- pregnant women with or without pelvic girdle pain
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Närhälsan Gibraltargatan rehabmottagning
Gothenburg, 41132
Annelie Gutke, RPT, PhD, 0768986007, annelie.gutke@gu.se
Annelie Gutke, RPT, PhD
- Recruiting
Närhälsan Eriksberg rehabmottagning
Gothenburg, 41764
Annelie Gutke, RPT, PhD, 0768986007, annelie.gutke@vgregion.se
PhD student, 0768986007 ext. +46(0)73065191, bodil.halvarsson@gu.se
About this study
Official title: WOMENinMOTION An Intervention Model for Pelvic Girdle Pain to Acquire Health-promoting Habits in Pregnancy and Prevent Chronic Pain in Women
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.
Read more
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.
- Conditions
- Pelvic Girdle Pain, Physical Activity
- Being tested
- knowledge, motivation for behavioral change
- Keywords
- pregnancy-related pelvic girdle pain, prevention of chronic pain, health-promotion, pain education, digital intervention,
- Medical subject headings
- Pelvic Girdle Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
knowledgeOther
Also called individual clinical physiotherapy
-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 changeBehavioural
motivation to be physically active
| Study group | Role | What they receive |
|---|---|---|
| usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic)) | Experimental | 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 Receives: Other: knowledge; Behavioral: motivation for behavioral change |
| usual maternity health care | No intervention | usual maternity health care according to regional guidelines including general advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity: the Pregnancy Physical Activity Questionnaire
different domains of physical activity in every day life
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Health by EQ5D
Health-related quality of life by the EuroQol 5-dimension questionnaire.
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
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).
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
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).
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Function, summary of emotional components of pain
EMOTIONAL component of pain: Concern about pain - a Numeric Rating Scale of 0-10.
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Secondary outcomes (7)
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
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Prevalence of pelvic girdle pain
Prevalence of Pelvic Girdle Pain measured with self-administered pelvic pain provocation tests.
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Work ability
Work ability, measured by one question from the Work Ability Index.
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Evening pain
Evening pain intensity at its worst, measured by a NRS where 10 = worst pain
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Pain frequency
Pain frequency by question
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Depressive symptoms
Symptoms of depression, measured by the Edinburgh Postnatal Depression Scale
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
health economy
Health-economy evaluation with direct/indirect costs (days on sick leave, visits to health care providers).
Measured: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start19 Sep 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
- Investigators
- Annelie Gutke, PhD, associate professor, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158957
- Sponsor's protocol ID
- Västra Götaland_WIMPGP
- Other IDs
- 2022-00146, VGRINN-979977, VGRINN-993309
- Acronym
- WIMPGP
- Status last verified
- Oct 2024
- First submitted
- 28 Mar 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WOMENinMOTION An Intervention Model for Pelvic Girdle Pain to Acquire Health-promoting Habits in Pregnancy and Prevent Chronic Pain in Women
- ClinicalTrials.gov ID
- NCT07158957
- Acronym / sponsor ID
- WIMPGP / Västra Götaland_WIMPGP
- Conditions
- Pelvic Girdle Pain, Physical Activity
- Keywords
- pregnancy-related pelvic girdle pain, prevention of chronic pain, health-promotion, pain education, digital intervention,
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 19 Sep 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic)) | Experimental | Other: knowledge, Behavioral: motivation for behavioral changepregnant 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 |
| usual maternity health care | No intervention | –usual maternity health care according to regional guidelines including general advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pregnant women with or without pelvic girdle pain
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| knowledgeAlso: individual clinical physiotherapy-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 | usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic)) |
| motivation for behavioral changemotivation to be physically active | Behavioural | usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic)) |
Primary outcome
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
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.
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).
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).
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.
7 secondary outcomes
Person-centered function
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Prevalence of pelvic girdle pain
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Work ability
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Evening pain
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Pain frequency
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Depressive symptoms
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
health economy
Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Pelvic Girdle Pain
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Recruiting
Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
Recruiting
Effects of MET With and Without Lumbopelvic Manipulation
Anterior Pelvic Tilt
Active, not recruiting
Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annelie Gutke, PhD, associate professor principal investigator
Göteborg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing knowledge and motivation for behavioral change in people with Pelvic Girdle Pain and Physical Activity, run by Vastra Gotaland Region at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annelie Gutke, associate professor (0766185747, annelie.gutke@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity: the Pregnancy Physical Activity Questionnaire (time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.