Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-24 @ 5:33 PM
Study NCT ID:
NCT07158957
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WOMENinMOTION An Intervention Model for Pelvic Girdle Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059388', 'term': 'Pelvic Girdle Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 592}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fear avoidance belief', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Fear avoidance beliefs questionnaire subscale that measures physical activity (FABQ-PA). Zero is equivalent to no fear avoidance and 24 indicates the highest possible fear avoidance.'}, {'measure': 'Catastrophizing thoughts', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Using- Pain Catastrophizing Scale, ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 (no catastrophizing thoughts) to 52 (highest possible catastrophizing thoughts)'}], 'primaryOutcomes': [{'measure': 'Physical activity: the Pregnancy Physical Activity Questionnaire', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'different domains of physical activity in every day life'}, {'measure': 'Health by EQ5D', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Health-related quality of life by the EuroQol 5-dimension questionnaire.'}, {'measure': 'Function, summary of sensory components of pain', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'SENSORY component of pain: Severity and disability of Pelvic Girdle Pain - measured by the Pelvic Girdle Questionnaire (PGQ).'}, {'measure': 'Function, summary of cognitive components of pain', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'COGNITIVE component of pain: Self-efficacy for carrying out physical activity - measured by the Pregnancy-Exercise Self-Efficacy Scale (P-ESES).'}, {'measure': 'Function, summary of emotional components of pain', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'EMOTIONAL component of pain: Concern about pain - a Numeric Rating Scale of 0-10.'}], 'secondaryOutcomes': [{'measure': 'Person-centered function', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': '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'}, {'measure': 'Prevalence of pelvic girdle pain', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Prevalence of Pelvic Girdle Pain measured with self-administered pelvic pain provocation tests.'}, {'measure': 'Work ability', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Work ability, measured by one question from the Work Ability Index.'}, {'measure': 'Evening pain', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Evening pain intensity at its worst, measured by a NRS where 10 = worst pain'}, {'measure': 'Pain frequency', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Pain frequency by question'}, {'measure': 'Depressive symptoms', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Symptoms of depression, measured by the Edinburgh Postnatal Depression Scale'}, {'measure': 'health economy', 'timeFrame': 'From enrollment to gestational weeks 35, 4 months, 1 and 3.5 years after birth', 'description': 'Health-economy evaluation with direct/indirect costs (days on sick leave, visits to health care providers).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy-related pelvic girdle pain', 'prevention of chronic pain', 'health-promotion', 'pain education', 'digital intervention,'], 'conditions': ['Pelvic Girdle Pain', 'Physical Activity']}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.\n\nData 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.\n\nPlan 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with or without pelvic girdle pain\n\nExclusion Criteria:\n\n* previous fracture, malignancy or surgical interventions (pelvic floor, spine, pelvis, or hip) or disease of musculoskeletal-or nervous system\n* serious intercurrent diseases such as diabetes and high blood pressure.\n* multiple pregnancy.'}, 'identificationModule': {'nctId': 'NCT07158957', 'acronym': 'WIMPGP', 'briefTitle': 'WOMENinMOTION An Intervention Model for Pelvic Girdle Pain', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vastra Gotaland Region'}, 'officialTitle': 'WOMENinMOTION An Intervention Model for Pelvic Girdle Pain to Acquire Health-promoting Habits in Pregnancy and Prevent Chronic Pain in Women', 'orgStudyIdInfo': {'id': 'Västra Götaland_WIMPGP'}, 'secondaryIdInfos': [{'id': '2022-00146', 'type': 'OTHER_GRANT', 'domain': 'FORTE'}, {'id': 'VGRINN-979977', 'type': 'OTHER_GRANT', 'domain': 'Västra Götalandsregionens Innovationsfond'}, {'id': 'VGRINN-993309', 'type': 'OTHER_GRANT', 'domain': 'Västra Götalandsregionens Innovationsfond'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))', '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', 'interventionNames': ['Other: knowledge', 'Behavioral: motivation for behavioral change']}, {'type': 'NO_INTERVENTION', 'label': 'usual maternity health care', 'description': 'usual maternity health care according to regional guidelines including general advice'}], 'interventions': [{'name': 'knowledge', 'type': 'OTHER', 'otherNames': ['individual clinical physiotherapy'], 'description': '-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.\n\nWhen women consider the digital platform insufficient, they are referred to physiotherapy at clinic for physiotherapeutically individually coached content of WIM', 'armGroupLabels': ['usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))']}, {'name': 'motivation for behavioral change', 'type': 'BEHAVIORAL', 'description': 'motivation to be physically active', 'armGroupLabels': ['usual maternity health care + digital care (+when needed-WIM at physiotherapy clinic))']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41132', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Annelie Gutke, RPT, PhD', 'role': 'CONTACT', 'email': 'annelie.gutke@gu.se', 'phone': '0768986007'}, {'name': 'Annelie Gutke, RPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Närhälsan Gibraltargatan rehabmottagning', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '41764', 'city': 'Gothenburg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Annelie Gutke, RPT, PhD', 'role': 'CONTACT', 'email': 'annelie.gutke@vgregion.se', 'phone': '0768986007'}, {'name': 'PhD student', 'role': 'CONTACT', 'email': 'bodil.halvarsson@gu.se', 'phone': '0768986007', 'phoneExt': '+46(0)73065191'}, {'name': 'Annelie Gutke, RPT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Närhälsan Eriksberg rehabmottagning', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'centralContacts': [{'name': 'Annelie Gutke, associate professor', 'role': 'CONTACT', 'email': 'annelie.gutke@gu.se', 'phone': '0766185747'}, {'name': 'Bodil Halvarsson, PhD-student', 'role': 'CONTACT', 'email': 'bodil.halvarsson@gu.se', 'phone': '+46(0)73-0651911'}], 'overallOfficials': [{'name': 'Annelie Gutke, PhD, associate professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Göteborg University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Göteborg University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}