Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-01 @ 8:31 AM
Study NCT ID:
NCT03717532
Status:
TERMINATED
Last Update Posted:
2020-05-28
First Post:
2018-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046788', 'term': 'Patellofemoral Pain Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Inadequate/low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2018-10-19', 'studyFirstSubmitQcDate': '2018-10-22', 'lastUpdatePostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in Muscle Mass Measured by Biodex', 'timeFrame': '6 Weeks', 'description': 'Biodex dynamometer is used under standard of care to measure the extensor strength of both legs and have bilateral thigh circumference measured'}, {'measure': 'Decrease in Pain measured by Visual Analog Scale (VAS)', 'timeFrame': '6 Weeks', 'description': '100-mm horizontal line anchored at one end with the words "no pain" and at the other end with the words "worst pain imaginable."'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patellofemoral Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of blood restriction therapy by comparing increase in muscle mass and strength in patients that receive blood restriction therapy to patients who receive a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA class I-II\n* Diagnosed with patellofemoral pain syndrome\n\nExclusion Criteria:\n\n* Patients with confirmed radiographic evidence explaining knee pain\n* Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)\n* Younger than 18 years of age or older than 65\n* Any patient considered a vulnerable subject\n* Patients with impaired circulation, peripheral vascular compromise, Previous revascularization of the extremity, or severe hypertension\n* Patients with Sickle cell anemia or venous thromboembolism\n* Patients with Sickle cell anemia or venous thromboembolism\n* Patients with cancer or Lymphectomies\n* Patients with increased intracranial pressure"}, 'identificationModule': {'nctId': 'NCT03717532', 'briefTitle': 'Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Blood Flow Restriction Therapy in Patellofemoral Pain Syndrome', 'orgStudyIdInfo': {'id': '18-01123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Patellopain syndrome with Cuff', 'description': 'Patient will be prescribed to 6 weeks of physical therapy with a cuff around the affected leg during exercises', 'interventionNames': ['Procedure: Personalized Tourniquet System for Blood Flow Restriction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients with Patellopain syndrome with Placebo Cuff', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'PROCEDURE', 'description': 'Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.', 'armGroupLabels': ['Patients with Patellopain syndrome with Placebo Cuff']}, {'name': 'Personalized Tourniquet System for Blood Flow Restriction', 'type': 'PROCEDURE', 'description': 'Patients will be receiving blood flow restriction therapy with a pressure cuff', 'armGroupLabels': ['Patients with Patellopain syndrome with Cuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Guillen Gonzalez-Lomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}