WOMENinMOTION An Intervention Model for Pelvic Girdle Pain (WIMPGP)

Vastra Gotaland Region

Status: Enrolling

Conditions: Physical Activity; Pelvic Girdle Pain

Treatments: Behavioral: motivation for behavioral change; Other: knowledge

Study type: Interventional

Funder types: Other

Identifiers

NCT07158957

VGRINN-979977 (Other Grant/Funding Number)

VGRINN-993309 (Other Grant/Funding Number)

2022-00146 (Other Grant/Funding Number)

Västra Götaland_WIMPGP

Details and patient eligibility

About

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.

Enrollment: 592 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

592 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Other: knowledge

Behavioral: motivation for behavioral change

usual maternity health care

No Intervention group

Description:

usual maternity health care according to regional guidelines including general advice