BFR Therapy in Patients With Rotator Cuff Tears

Summary

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy in patients treated both non operatively and operatively for rotator cuff tears (RCT). BFR has been proposed to work by restricting arterial inflow leading to an oxygen depleted environment and the ability to induce muscle adaption at lower maximum repetition via reactive hyperemia. Muscle atrophy occurs following rotator cuff tear. Thus, physical therapy is used to regain strength with the ultimate goal of returning to activity.

The goal of this investigation is to determine if using BFR during therapy for non-operatively managed and operatively managed rotator cuff tears would lead to increased and expedited strength gains. Additionally the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration often seen in the setting of rotator cuff tear, as it is known that cuff tears can subject the muscles to degenerative changes and these patients are at risk for poorer clinical outcomes. The investigators will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding rotator cuff tear after both nonoperative treatment with therapy and operative treatment with surgical repair and peri-operative rehabilitation.

The investigators hypothesize that the BFR group will have significantly greater strength gains at all time points. Previous studies have shown that BFR has potential in increasing muscle torque generation and cross sectional area in the first six months following anterior cruciate ligament (ACL) reconstruction. While there have not been as many studies investigating the use of BFR following upper extremity surgery, previous research has demonstrate that BFR can be useful both proximal and distal to the targeted muscle groups in the upper extremity. In addition to the paucity of research on post-operative BFR following rotator cuff repair (RCR), there is no evidence on pre-operative use as well. The investigators believe that the use of BFR in the perioperative period surrounding rotator cuff tear and repair has the potential to significantly decrease muscle atrophy and lead to faster, more substantial strength gains and less muscle atrophy and fatty infiltration.

Conditions

• Blood Flow Restriction

Interventions

DEVICE

Blood Flow Restriction Therapy

Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.

PROCEDURE

Traditional Therapy

Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.

Sponsors & Collaborators

• Henry Ford Health System

  lead OTHER

Principal Investigators

• Lafi S Khalil, MD · Henry Ford Health System

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-06-01

Primary Completion

2022-05-01

Completion

2022-07-01

FDA Device

Yes

Countries

• United States

Study Locations