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BFR for Shoulder Labrum Tear

N/A
Waitlist Available
Led By Adam Anz, MD
Research Sponsored by Andrews Research & Education Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
Awards & highlights

Study Summary

This trial will compare the effects of blood flow restriction training with regular rehabilitation on patients' self-reported measures of progress and shoulder muscle size following glenoid labral repair surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Pennsylvania Shoulder Score (PENN)
Secondary outcome measures
Change in Global Rating of Change (GROC)
Change in Pain Scale
Change in Patient Acceptable Symptom State (PASS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Blood Flow Restriction (BFR)Experimental Treatment1 Intervention
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.
Group II: Standard Rehabilitation (Control Group)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BFR
2019
N/A
~30

Find a Location

Who is running the clinical trial?

Andrews Research & Education FoundationLead Sponsor
18 Previous Clinical Trials
879 Total Patients Enrolled
Adam Anz, MDPrincipal InvestigatorAndrews Institute for Sports Medicine and Orthopaedics
7 Previous Clinical Trials
370 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Alabama
How old are they?
18 - 65
What site did they apply to?
Andrews Institute for Orthopaedics & Sports Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Blood Flow Restriction Training Following Glenoid Labral Repair
2019. "Blood Flow Restriction Training Following Glenoid Labral Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03675620.
~0 spots leftby Apr 2025
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