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Blood Flow Restriction Training Following Glenoid Labral Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675620
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Andrews Research & Education Foundation

Brief Summary:

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.

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.


Condition or disease Intervention/treatment Phase
Glenoid Labrum Tear Device: BFR Other: Standard Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: Investigators recording data and the patients physician will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: Effects of Blood Flow Restriction Training Compared With Standard Rehabilitation in Patients Following Glenoid Labral Repair
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Active Comparator: Standard Rehabilitation (Control Group)
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.
Other: Standard Rehabilitation
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.

Experimental: Blood Flow Restriction (BFR)
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.
Device: BFR
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.




Primary Outcome Measures :
  1. Change in Pennsylvania Shoulder Score (PENN) [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    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.


Secondary Outcome Measures :
  1. Change in Global Rating of Change (GROC) [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    Survey that assesses participants change in pain overall, since their injury, since their last physical therapy visit, and since the start of physical therapy

  2. Change in Pain Scale [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    Survey assessing current level of pain

  3. Change in Patient Acceptable Symptom State (PASS) [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    Survey utilizing a 2-item question asking participants their opinion of their current state

  4. Change in Single Assessment Numeric Evaluation (SANE) [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    Survey using a visual analog scale to rate current pain

  5. Change in Patient Centered Outcome Questionnaire [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    Survey that assesses pain, fatigue, distress, and interference with daily activities

  6. Change in Shoulder Girth [ Time Frame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery ]
    Circumference of the upper arm will be measured with a tape measure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair
  • Willing to complete their post-operative rehabilitation at Andrews Institute Physical Therapy

Exclusion Criteria:

  • Patients with prior procedures or significant injuries to the same shoulder will be excluded
  • Patients with arthroscopic debridement of labral tears alone
  • Patients with concomitant rotator cuff repair surgery
  • Patients with Workers' Compensation or automobile insurance claim will be excluded.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675620


Contacts
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Contact: Hillary Plummer, PhD 850-916-8796 hillary.plummer@andrewsref.org

Locations
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United States, Florida
Andrews Institute for Orthopaedics & Sports Medicine Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Hillary Plummer, PhD    850-916-8796    hillary.plummer@andrewsref.org   
Principal Investigator: Roger Ostrander, MD         
Sub-Investigator: Adam Anz, MD         
Sub-Investigator: Steve Jordan, MD         
Sponsors and Collaborators
Andrews Research & Education Foundation
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Responsible Party: Andrews Research & Education Foundation
ClinicalTrials.gov Identifier: NCT03675620    
Other Study ID Numbers: 1309802
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes