Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 3:57 PM
Study NCT ID:
NCT05237869
Status:
RECRUITING
Last Update Posted:
2025-04-25
First Post:
2021-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction & Tennis Elbow Rehab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013716', 'term': 'Tennis Elbow'}], 'ancestors': [{'id': 'D000070639', 'term': 'Elbow Tendinopathy'}, {'id': 'D052256', 'term': 'Tendinopathy'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000092464', 'term': 'Elbow Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-22', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Define the effect of BFR training on pain with activity in patients with LE.', 'timeFrame': '3 weeks to 6 months', 'description': 'Measured on a 0-10 scale by VAS (Visual Analog Scale) patient reported outcome form. The VAS is scored 0-10, and a higher score indicates worse pain/worse outcomes.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Lateral Epicondylitis']}, 'descriptionModule': {'briefSummary': 'Lateral epicondylitis (LE), often referred to as "tennis elbow" is a common and debilitating overuse injury affecting 1-3% of adults annually. LE is most often defined as a syndrome of pain near the area of the lateral epicondyle of the elbow commonly effecting the origin of the extensor carpi radialis brevis with associated weakness; it most commonly effects the dominant arm. The best treatment for LE is unknown and research to support current treatment methods are insufficient. A common limitation in functional recovery experienced by this population is pain at the lateral aspect of the elbow. As such, innovative therapeutic interventions directed at quickly reducing pain may address this unmet need and allow for improved outcomes, as well as earlier return to function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages 18-65 years of age\n2. Diagnosis of lateral epicondylitis confirmed by the treating orthopaedic surgeon and ultrasound\n3. Must be able to read and write in English\n4. Able to provide own written consent\n\nExclusion Criteria:\n\n1. Patients over 65 years of age\n2. Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength or daily pain greater than 1/10\n3. History of prior injection for treatment of lateral epicondylitis\n4. Pregnancy\n5. Recent history of deep venous thrombosis (within the past 12 months)\n6. Active treatment with anticoagulants\n7. History of upper quadrant lymph node dissection\n8. History of endothelial dysfunction\n9. Patient history of easy bruising\n10. Active infection in the injured arm\n11. Cancer\n12. Uncontrolled peripheral vascular disease\n13. Uncontrolled diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT05237869', 'briefTitle': 'Blood Flow Restriction & Tennis Elbow Rehab', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Blood Flow Restricted Training to Enhance Lateral Epicondylitis Rehabilitation.', 'orgStudyIdInfo': {'id': '2070985'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Physical Therapy', 'description': 'For patients enrolled in the control group, the participants will undergo calibration of the Delfi Personalized Tourniquet System to measure limb occlusion pressure and will wear the cuff during completion of the exercises with minimal inflation (approximately 5%), to hold the cuff in place during treatment. This will act as a sham.', 'interventionNames': ['Other: Standard Physical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Blood Flow Restricted Physical Therapy', 'description': 'Physical therapy assisted by blood flow restriction per standard physical therapy protocol.', 'interventionNames': ['Device: Blood Flow Restriction Device']}], 'interventions': [{'name': 'Blood Flow Restriction Device', 'type': 'DEVICE', 'description': 'Occlusion training involves the application of a cuff to the upper arm that is designed to restrict only the low-pressure blood flow in veins. It does not prevent blood flowing from the heart to the arm.', 'armGroupLabels': ['Blood Flow Restricted Physical Therapy']}, {'name': 'Standard Physical Therapy', 'type': 'OTHER', 'description': 'Standard physical therapy protocol for lateral epicondylitis rehab without blood flow restriction.', 'armGroupLabels': ['Physical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vicki Jones, MEd, CCRP', 'role': 'CONTACT', 'email': 'jonesvicki@health.missouri.edu', 'phone': '573-882-7583'}], 'facility': 'Vicki Jones', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}], 'centralContacts': [{'name': 'Vicki Jones, MEd, CCRP', 'role': 'CONTACT', 'email': 'jonesvicki@health.missouri.edu', 'phone': '5738827583'}], 'overallOfficials': [{'name': 'Julia Nuelle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Missouri Department of Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Julie Nuelle', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Orthopaedic Surgery, Hand Surgeon', 'investigatorFullName': 'Julie Nuelle', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}