Blood Flow Restriction Training Following Glenoid Labral Repair

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Glenoid Labrum Tear
• Intervention / Treatment: Other: Standard Rehabilitation; Device: BFR

Detailed Description

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hillary Plummer, PhD; Phone Number: 850-916-8796; Email: hillary.plummer@andrewsref.org

Study Locations

• United States
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews Institute for Orthopaedics & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Andrews Research & Education Foundation
• Investigators: Principal Investigator: Adam Anz, MD, Andrews Institute for Sports Medicine and Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): December 7, 2022
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1309802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes