Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT07292051
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Blood Flow Restriction Technique on Postpartum Pelvic Girdle Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pelvic girdle pain intensity ( pain index )', 'timeFrame': 'Baseline , 8 weeks and 16 weeks', 'description': 'In this study, pain severity will be measured using the mean of three 11-point NRS questionnaires for least, usual, and current pain over the previous 2 weeks.'}], 'secondaryOutcomes': [{'measure': 'pelvic girdle-related disability', 'timeFrame': 'Baseline , 8 weeks and 16 weeks', 'description': 'pelvic girdle-related disability, measured by pelvic girdle questionnaire (PGQ)'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Baseline , 8 weeks and 16 weeks', 'description': 'Health-related quality of life, measured by the Arabic version of European quality of life-Five-Dimension Five-Level Instrument (EQ-5d-5L)'}, {'measure': 'Kinesiophobia', 'timeFrame': 'Baseline , 8 weeks and 16 weeks', 'description': 'Kinesiophobia measured by an Arabic Tampa scale'}, {'measure': 'Global improvement', 'timeFrame': 'Baseline , 8 weeks and 16 weeks', 'description': 'Global improvement measured by global rating of change (GROC) scale'}, {'measure': 'Active straight leg raises repositioning error (ASLR-RE)', 'timeFrame': 'Baseline , 8 weeks and 16 weeks', 'description': 'ASLR-RE angle, measured by Image J'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Pelvic Girdle Pain']}, 'descriptionModule': {'briefSummary': 'Purpose of the study :\n\nThe purpose of the current study is investigating the effect of Blood Flow Restriction Training technique on postpartum pelvic girdle pain.', 'detailedDescription': 'This study is a randomized controlled trial. To fulfill its purpose, we have two groups; control group (A) and experimental group (B) are two matched postpartum pelvic girdle pain groups. While group (A) will receive a core stability exercise program, group (B) will receive core stability exercise program with blood flow restriction technique.\n\nThe primary outcome measure will be pelvic girdle pain intensity, while the secondary outcomes will include pelvic girdle-related disability, health-related quality of life, Kinesiophobia , global improvement and ASLR-RE angle.\n\nTreatment duration will be eight weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients will be eligible for the study if they met all the following criteria:\n\n 1. Are between 3 and 12 months postpartum.\n 2. Are aged between 20 and 35 years.\n 3. Have a body mass index (BMI) \\< 30 kg/m².\n 4. Reported experiencing pelvic girdle pain-defined as pain localized between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints-that either began during pregnancy or persisted after delivery .\n 5. Presented with a positive Active Straight Leg Raise (ASLR) test.\n 6. Showed positive findings in at least two of the following six pelvic pain provocation tests:\n\n * Posterior Pelvic Pain Provocation (P4/Thigh Thrust) Test\n * Patrick's (FABER) Test\n * Long Dorsal Sacral Ligament Test\n * Pelvic Compression Test\n * Pelvic Distraction (Separation) Test\n * Sacral Thrust Test\n\nExclusion Criteria:\n\n* -Patients will be excluded if they have any of the following:\n\n 1. If they were Pregnant\n 2. Known causes of pelvic girdle pain, such as fractures and rheumatism\n 3. Undergone lumbar or pelvic surgery in the past\n 4. Current neurological symptoms and signs in lower extremities such as lumbar radiculopathy and myelopathy\n 5. Cancer\n 6. Cardiovascular disease\n 7. Experience with structured and supervised core or trunk exercise training programs"}, 'identificationModule': {'nctId': 'NCT07292051', 'briefTitle': 'Effect of Blood Flow Restriction Technique on Postpartum Pelvic Girdle Pain', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of Blood Flow Restriction Technique on Postpartum Pelvic Girdle Pain', 'orgStudyIdInfo': {'id': 'KFSIRB200-813'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group (A)', 'description': 'Group (A) will receive a core stability exercise program.', 'interventionNames': ['Other: Core Stability Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Group (B)', 'description': 'Group (B) will receive core stability exercise program with blood flow restriction technique.', 'interventionNames': ['Other: Core Stability Exercise', 'Other: Blood Flow Restriction Technique']}], 'interventions': [{'name': 'Core Stability Exercise', 'type': 'OTHER', 'description': 'Patients will receive specific core stabilizing exercises, focusing on Pelvic floor muscles ,Gluteus maximus, Gluteus Medius, specific abdominal muscles , the lumbar multifidus, and Erector spinae.', 'armGroupLabels': ['Group (A)', 'Group (B)']}, {'name': 'Blood Flow Restriction Technique', 'type': 'OTHER', 'description': 'Patients will receive the same core stability exercise added to Blood Flow Restriction Technique', 'armGroupLabels': ['Group (B)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'jilan Adel, lecturer', 'role': 'CONTACT', 'email': 'gelan_youssif@pt.kfs.edu.eg', 'phone': '01007519909', 'phoneExt': '+20'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Nour Abdelaty Attia El-desouky', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}