NCT04384120

BFR Therapy in Patients With Rotator Cuff Tears

Terminated NA Results posted Last updated 5 June 2025

What this trial tests

NA trial testing Blood Flow Restriction Therapy in Blood Flow Restriction in 30 participants. Terminated before completion.

Timeline

1 June 2020

Primary endpoint
1 May 2022

1 July 2022

Quick facts

Lead sponsor	Henry Ford Health System
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	1 June 2020
Primary completion	1 May 2022
Estimated completion	1 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Blood Flow Restriction Therapy
• Traditional Therapy — full drug profile →

Conditions studied

• Blood Flow Restriction — all drugs for Blood Flow Restriction →

Sponsor

Henry Ford Health System — full company profile →

Who can join

Adults 18 to 80, any sex, with Blood Flow Restriction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Strength Primary · through study completion, an average of 12 months post-operative follow-up

Strength will be quantified through dynamometers

Group	Value	95% CI
Rotator Cuff Rehabilitation Using BFR	7.39	± 3.93
Rotator Cuff Rehabilitation Without BFR	6.05	± 3.1

Range of Motion Secondary · through study completion, an average of 12 months post-operative follow-up

Range of motion of the shoulder will be assessed using a goniometer

Group	Value	95% CI
Rotator Cuff Rehabilitation Using BFR	82.4	± 24.7
Rotator Cuff Rehabilitation Without BFR	65.1	± 18.8

Pain Score Secondary · through study completion, an average of 12 months post-operative follow-up

Pain will be assessed using a visual analogue scale (VAS), a pain scale from 0-10 where higher numbers indicate worse pain

Group	Value	95% CI
Rotator Cuff Rehabilitation Using BFR	30.3	± 4.7
Rotator Cuff Rehabilitation Without BFR	26.3	± 6.3

Patient Reported Outcomes Measurement Information System Secondary · through study completion, an average of 12 months post-operative follow-up

Patient reported outcome measurement information system (PROMIS) scores will be collected through a series of questionnaires from the PROMIS domain of physical function, upper extremity, and depression. These scores are standardized T-scores with the mean set at 50 and the standard deviation set at 10. PROMIS scores for Physical function, the higher the score the better. PROMIS score for depression, the lower the score the better. PROMIS score for Upper extremity, the higher the score the better.

PROMIS-UE

Group	Value	95% CI
Rotator Cuff Rehabilitation Using BFR	30.3	± 4.7
Rotator Cuff Rehabilitation Without BFR	26.3	± 6.3

PROMIS-PI

Group	Value	95% CI
Rotator Cuff Rehabilitation Using BFR	63	± 8.8
Rotator Cuff Rehabilitation Without BFR	63	± 6.7

PROMIS-D

Group	Value	95% CI
Rotator Cuff Rehabilitation Using BFR	47	± 9.8
Rotator Cuff Rehabilitation Without BFR	47	± 9.4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.