WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

NCT07158957 | Recruiting

• 4 other identifiers: Västra Götaland_WIMPGP2022-00146VGRINN-979977VGRINN-993309
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 2

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.

Conditions

Pelvic Girdle Pain; Physical Activity

Keywords

pregnancy-related pelvic girdle pain; prevention of chronic pain; health-promotion; pain education; digital intervention,

Outcome Measures

Primary Outcomes (5)

• Physical activity: the Pregnancy Physical Activity Questionnaire

  different domains of physical activity in every day life

  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.

  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).

  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).

  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.

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

Secondary Outcomes (7)

• Person-centered function

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

• Prevalence of pelvic girdle pain

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

• Work ability

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

• Evening pain

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

• Pain frequency

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

Other Outcomes (2)

• Fear avoidance belief

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

• Catastrophizing thoughts

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

Study Arms (2)

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

Other: knowledge; Behavioral: motivation for behavioral change

usual maternity health care

NO INTERVENTION

usual maternity health care according to regional guidelines including general advice

Interventions

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

Also known as: individual clinical physiotherapy

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

motivation for behavioral change BEHAVIORAL

motivation to be physically active

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• pregnant women with or without pelvic girdle pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Göteborg University: collaborator

Study Sites (2)

Närhälsan Gibraltargatan rehabmottagning

Gothenburg, 41132, Sweden

RECRUITING

Närhälsan Eriksberg rehabmottagning

Gothenburg, 41764, Sweden

RECRUITING

MeSH Terms

Conditions

Pelvic Girdle Pain; Motor Activity

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Behavior

Study Officials

• Annelie Gutke, PhD, associate professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annelie Gutke, associate professor

CONTACT

0766185747; annelie.gutke@gu.se

Bodil Halvarsson, PhD-student

CONTACT

+46(0)73-0651911; bodil.halvarsson@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: September 8, 2025
• Study Start: September 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)