Blood Flow Restriction Training Following Glenoid Labral Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effects of Blood Flow Restriction Training Compared With Standard Rehabilitation in Patients Following Glenoid Labral Repair

Conditions
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Glenoid Labrum Tear

Intervention / Treatment
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* Device: BFR
* Other: Standard Rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Rehabilitation (Control Group)<br>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<br>* 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.<br>|
| Experimental: Blood Flow Restriction (BFR)<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Global Rating of Change (GROC) | Survey that assesses participants change in pain overall, since their injury, since their last physical therapy visit, and since the start of physical therapy | Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery | 
| Change in Pain Scale | Survey assessing current level of pain | Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery | 
| Change in Patient Acceptable Symptom State (PASS) | Survey utilizing a 2-item question asking participants their opinion of their current state | Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery | 
| Change in Single Assessment Numeric Evaluation (SANE) | Survey using a visual analog scale to rate current pain | Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery | 
| Change in Patient Centered Outcome Questionnaire | Survey that assesses pain, fatigue, distress, and interference with daily activities | Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery | 
| Change in Shoulder Girth | Circumference of the upper arm will be measured with a tape measure | Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery |