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Recruiting NCT07158957

WOMENinMOTION An Intervention Model for Pelvic Girdle Pain

No phase Interventional Pelvic Girdle Pain Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: knowledge, motivation for behavioral change.
Who it may be relevant to
Registry conditions: Pelvic Girdle Pain, Physical Activity. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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 individual
  • Behavioral motivation for behavioral change
    motivation to be physically active

Primary outcome measures

  • Physical activity: the Pregnancy Physical Activity Questionnaire [Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
  • Health by EQ5D [Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
  • Function, summary of sensory components of pain [Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
  • Function, summary of cognitive components of pain [Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
  • Function, summary of emotional components of pain [Time frame: From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Sweden · 2 centers
  • Närhälsan Gibraltargatan rehabmottagning — Gothenburg
  • Närhälsan Eriksberg rehabmottagning — Gothenburg

Identifiers

NCT: NCT07158957 · Västra Götaland_WIMPGP · 2022-00146 · VGRINN-979977 · VGRINN-993309

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗