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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 is a NA study that was terminated before completion, run by Henry Ford Health System. The registered enrollment target is 30 participants.
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
Interventions
- DEVICE Blood Flow Restriction Therapy
- PROCEDURE Traditional Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-06-01 |
| Est. Completion | 2022-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04384120
The ClinicalTrials.gov registry entry for NCT04384120 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry Ford Health System, which has 234 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Blood Flow Restriction Therapy is the first listed.
NCT04384120 reports 0 study locations.
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.
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