Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-03 @ 4:14 AM
Study NCT ID:
NCT03675620
Status:
WITHDRAWN
Last Update Posted:
2024-02-06
First Post:
2018-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood Flow Restriction Training Following Glenoid Labral Repair
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': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigators recording data and the patients physician will be blinded to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number generator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principal Investigator left research facility.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2018-09-17', 'studyFirstSubmitQcDate': '2018-09-17', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pennsylvania Shoulder Score (PENN)', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'The Penn Shoulder Score contains a visual analog scale pain score for pain at rest, pain with everyday activities, and pain with strenuous activities. The maximum possible score is 100 points.'}], 'secondaryOutcomes': [{'measure': 'Change in Global Rating of Change (GROC)', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'Survey that assesses participants change in pain overall, since their injury, since their last physical therapy visit, and since the start of physical therapy'}, {'measure': 'Change in Pain Scale', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'Survey assessing current level of pain'}, {'measure': 'Change in Patient Acceptable Symptom State (PASS)', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'Survey utilizing a 2-item question asking participants their opinion of their current state'}, {'measure': 'Change in Single Assessment Numeric Evaluation (SANE)', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'Survey using a visual analog scale to rate current pain'}, {'measure': 'Change in Patient Centered Outcome Questionnaire', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'Survey that assesses pain, fatigue, distress, and interference with daily activities'}, {'measure': 'Change in Shoulder Girth', 'timeFrame': 'Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery', 'description': 'Circumference of the upper arm will be measured with a tape measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Glenoid Labrum Tear']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effects of BFR training on patient reported outcome measures and shoulder muscle girth in patients following glenoid labral repair. The investigators hypothesize that participants receiving BFR with rehabilitation will have greater improvements in patient reported outcome measures and shoulder muscle girth than participants who are treated without BFR.', 'detailedDescription': 'Patients between the ages of 18 and 55 who had a superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair will be screened for participation in this study. Participants will be randomized in a 1:1 ratio to receive standard physical therapy with blood flow restriction training or without blood flow restriction. Participants will receive standard of care rehabilitation for labral repair regardless of group assignment. The length of each physical therapy session will be approximately one hour. The BFR and control group will perform leg press and leg extension exercises prior to shoulder strengthening. The resistance for both groups will be set as 30% of one repetition maximum (1-RM). The goal will be for the participants to perform 4 sets of repetitions sequenced 30, 15, 15, 15 of each exercise, if this is not obtainable then the number of set/repetitions will be decreased. The lower extremity strengthening exercises for this study will be performed by all participants beginning at the first physical therapy visit post-surgery. These exercises will be performed at each physical therapy session for 6 consecutive weeks (approximately 2-3 sessions/week). Standard rehabilitation will continue at the conclusion of the 6-week intervention for all participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair\n* Willing to complete their post-operative rehabilitation at Andrews Institute Physical Therapy\n\nExclusion Criteria:\n\n* Patients with prior procedures or significant injuries to the same shoulder will be excluded\n* Patients with arthroscopic debridement of labral tears alone\n* Patients with concomitant rotator cuff repair surgery\n* Patients with Workers' Compensation or automobile insurance claim will be excluded.\n* Patients who have a medical history involving any of the following medical conditions will be excluded - uncontrolled hypertension, diabetes, autoimmune disorders, rheumatoid or psoriatic arthritis, multiple sclerosis, peripheral vascular disease, peripheral neuropathy, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, blood disorders, disorders requiring immunosuppression, cancer, an ongoing infectious disease, use of steroids, or significant cardiovascular, renal, hepatic or pulmonary disease"}, 'identificationModule': {'nctId': 'NCT03675620', 'briefTitle': 'Blood Flow Restriction Training Following Glenoid Labral Repair', 'organization': {'class': 'OTHER', 'fullName': 'Andrews Research & Education Foundation'}, 'officialTitle': 'Effects of Blood Flow Restriction Training Compared With Standard Rehabilitation in Patients Following Glenoid Labral Repair', 'orgStudyIdInfo': {'id': '1309802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Rehabilitation (Control Group)', 'description': 'All participants will perform traditional post-operative shoulder rehabilitation exercises. Participants randomized to this group will begin with lower extremity strengthening exercises (prior to shoulder strengthening) 2-3 times per week for for the first 6 weeks of post-operative care. Standard rehabilitation will continue until discharge.', 'interventionNames': ['Other: Standard Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Blood Flow Restriction (BFR)', 'description': 'All participants will perform traditional post-operative shoulder rehabilitation exercises. Participants randomized to the BFR group will begin combining BFR with lower extremity strengthening exercises (prior to shoulder strengthening) 2-3 times per week for the first 6 weeks post-operative care. Standard rehabilitation will continue until discharge.', 'interventionNames': ['Device: BFR']}], 'interventions': [{'name': 'BFR', 'type': 'DEVICE', 'description': "Delfi's Personalized Tourniquet System for Blood Flow Restriction will be used with leg extension and leg press exercises. Bilateral thigh cuffs will be applied to the participants and occlusion pressure will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each participant will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions) with resistance of 30% 1-repetition maximum. The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between exercises. Sets and repetitions will remain constant for each participant; however, resistance will be incrementally increased.", 'armGroupLabels': ['Blood Flow Restriction (BFR)']}, {'name': 'Standard Rehabilitation', 'type': 'OTHER', 'description': 'The control group will perform perform 4 sets of leg extensions and leg press (1 set of 30 repetitions followed by 3 sets of 15 repetitions) with resistance of 30% 1-repetition maximum. Sets and repetitions will remain constant for each participant; however, resistance will be incrementally increased.', 'armGroupLabels': ['Standard Rehabilitation (Control Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32561', 'city': 'Gulf Breeze', 'state': 'Florida', 'country': 'United States', 'facility': 'Andrews Institute for Orthopaedics & Sports Medicine', 'geoPoint': {'lat': 30.35714, 'lon': -87.16386}}], 'overallOfficials': [{'name': 'Adam Anz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Andrews Institute for Sports Medicine and Orthopaedics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrews Research & Education Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}