Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-11 @ 6:00 PM
Study NCT ID:
NCT06470620
Status:
RECRUITING
Last Update Posted:
2025-04-29
First Post:
2024-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-27', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Consultation on Incontinence Questionnaire', 'timeFrame': 'baseline', 'description': 'evaluating the frequency, severity and impact on quality of life of urinary incontinence. The score ranges from 0-21, with a higher score indicating greater severity'}, {'measure': 'pelvic floor muscle function assessed as correct movement of the urinary bladder', 'timeFrame': 'baseline', 'description': 'upward or downward displacement of urinary bladder will be measured via diagnostic ultrasound. Upward movement is considered the correct direction describing good function of pelvic floor muscles'}, {'measure': 'urinary bladder displacement in millimeters', 'timeFrame': 'baseline', 'description': 'bladder displacement will be measured via diagnostic ultrasound using the on screen caliper tool'}, {'measure': 'pelvic floor muscles endurance of contraction in seconds', 'timeFrame': 'baseline', 'description': 'The participant is instructed to contract pelvic floor muscle and hold the contraction as long as possible. bladder status on ultrasound is assessed. When the bladder starts to move downward from its position the examination ends. (measured in sec).'}], 'secondaryOutcomes': [{'measure': 'muscle strength', 'timeFrame': 'baseline', 'description': 'hip muscle abduction sill be measure via hand held dynamometer'}, {'measure': 'hip function assessment', 'timeFrame': 'baseline', 'description': 'International Hip Outcome Tool 12 questionnaire. range 0-100, with a high score indicates a high quality of life'}, {'measure': 'self-reporting of fear and anxiety of hip pain regarding quality of life', 'timeFrame': 'baseline', 'description': 'Hospital Anxiety \\& Depression Scale'}, {'measure': 'hip range of motion', 'timeFrame': 'baseline', 'description': 'range of motion will be assessed with goniometer'}, {'measure': 'function assesment', 'timeFrame': 'baseline', 'description': 'single leg squat'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pelvic floor', 'women health', 'ultrasound', 'incontinence'], 'conditions': ['Incontinence Stress', 'Incontinence', 'Hip Pain Chronic']}, 'referencesModule': {'references': [{'pmid': '36141380', 'type': 'BACKGROUND', 'citation': 'Dar G, Saban TS. The Perception of Pelvic Floor Muscle Function amongst Exercising Women Who Are Repeatedly Instructed to Contract Their Pelvic Floor Muscles. Healthcare (Basel). 2022 Sep 14;10(9):1768. doi: 10.3390/healthcare10091768.'}]}, 'descriptionModule': {'briefSummary': 'This study examines the relationship between pelvic floor muscle (PFM) function and self-perception of PFM contraction with hip pain, their severity, and hip muscle strength.\n\nIn addition, it will examines the association between PFM function, and anxiety.', 'detailedDescription': 'This cross-sectional study will include women with symptoms of hip-related pain persisting \\> three months(research group), and women without hip pain (control group). A single session will include various assessments as follows: abdominal ultrasound examination to evaluate PFM function and endurance, in addition, each participant will evaluate her ability to perform correct contraction of PFM, hand-held dynamometer testing for hip rotator muscle strength, the International Consultation on Incontinence Questionnaire (ICIQ) for evaluating symptoms and impact of urinary incontinence, the International Hip Outcome Tool 12 for assessing hip function and pain, the Hospital Anxiety \\& Depression Scale (HADS), and a functional performance task involving the hip muscles - a single-leg squat.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'women with and without hip related pain', 'genderDescription': 'the study examine pelvic floor muscle function among women', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Research Group:\n\n* complaints of hip related pain,\n* Visual Analog Scale (VAS) \\>3 for three months,\n* with one or more of the symptoms relevant to the syndrome - (1) hip or groin pain produced by a certain movement or position, stiffness and limitation of movement or clicks from the hip joint, (2) examination A positive FADIR performed by the researcher before conducting the study\n\nExclusion criteria:\n\n* the presence of additional diagnoses of the slipped capital femoral epiphysis,\n* Perthes disease,\n* avascular necrosis, and osteoarthritis-Calve-Legg,\n* neurological or Metabolism,\n* surgery/fracture in the hip joint of which the woman complains,\n* pregnancy or childbirth in the last year,\n* Treatment of the pelvic floor in the last year.\n\ncontrol group - health women without any pain or symptoms in the spine and lower extremities'}, 'identificationModule': {'nctId': 'NCT06470620', 'briefTitle': 'The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Haifa'}, 'officialTitle': 'The Relationship Between Pelvic Floor Muscle Function and Hip Pain Among Women', 'orgStudyIdInfo': {'id': '122/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'research group', 'description': 'women with hip-related pain', 'interventionNames': ['Diagnostic Test: pelvic floor muscle assessment']}, {'label': 'control group', 'description': 'healthy women without hip pain', 'interventionNames': ['Diagnostic Test: pelvic floor muscle assessment']}], 'interventions': [{'name': 'pelvic floor muscle assessment', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['abdominal ultrasound'], 'description': 'no intervention will be performed - several diagnostic assessments tools', 'armGroupLabels': ['control group', 'research group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31905', 'city': 'Haifa', 'state': 'Haifa District', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Haifa University, Department of PHysical Therapy', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Gali Dar, Prof', 'role': 'CONTACT', 'email': 'galidar@yahoo.com', 'phone': '0505662054'}], 'overallOfficials': [{'name': 'Gali Dar, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Haifa'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': '6 months following end of study', 'ipdSharing': 'YES', 'description': 'following study completion, a paper will be submitted to international professional journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Haifa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PHD, Prof.', 'investigatorFullName': 'Gali Dar', 'investigatorAffiliation': 'University of Haifa'}}}}