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NCT04384120 · ClinicalTrials.gov registry record · NA

BFR Therapy in Patients With Rotator Cuff Tears

A NA study, sponsored by Henry Ford Health System.

Terminated
Registry status
NA
Development phase
30
Enrollment target

NCT04384120: Clinical Trial NA study, sponsored by Henry Ford Health System.

NCT04384120 is a NA study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 30 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04384120, a NA study, was terminated before completion, sponsored by Henry Ford Health System.

TERMINATED
Registry status
NA
Development phase
30 participants
Enrollment target

Study 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 rotato

Primary Outcome

Strength will be quantified through dynamometers

Interventions

  • DEVICE Blood Flow Restriction Therapy
  • PROCEDURE Traditional Therapy

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-06-01
Est. Completion 2022-07-01
Phase NA
Henry Ford Health System

234 total trials

Why NCT04384120 stopped before completion

NCT04384120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Blood Flow Restriction Therapy is the first listed.

NCT04384120 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04384120 about?

NCT04384120 is a clinical study titled "BFR Therapy in Patients With Rotator Cuff Tears". 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 a...

What is the current status of trial NCT04384120?

This trial is currently terminated. It is a NA study. The enrollment target is 30 participants. The study started on 2020-06-01. Estimated completion is 2022-07-01.

What interventions are being tested in trial NCT04384120?

The interventions under investigation include: Blood Flow Restriction Therapy (DEVICE), Traditional Therapy (PROCEDURE).

Who is sponsoring clinical trial NCT04384120?

This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04384120's enrollment target sits among peer trials

30 1593rd of 2000 higher than 299 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04384120, the US trial registry maintained by the National Library of Medicine. NCT04384120 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.