BFR Therapy in Patients With Rotator Cuff Tears

NCT04384120 | Terminated Results DMC FDA Device

• 1 other identifier: 13130
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Strength

  Strength will be quantified through dynamometers

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

Secondary Outcomes (3)

• Range of Motion

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

• Pain Score

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

• Patient Reported Outcomes Measurement Information System

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

Study Arms (2)

Rotator Cuff Rehabilitation Using BFR

EXPERIMENTAL

Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation using blood flow restriction cuffs. 1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs. 2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.

Device: Blood Flow Restriction Therapy

Rotator Cuff Rehabilitation Without BFR

ACTIVE COMPARATOR

Patients with rotator cuff tears who plan for either nonoperative treatment with physical therapy or operative treatment with arthroscopic rotator cuff repair (RCR) surgery will be randomized to undergo rehabilitation without using blood flow restriction cuffs. 1. Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs. 2. Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.

Procedure: Traditional Therapy

Interventions

Blood Flow Restriction Therapy DEVICE

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.

Rotator Cuff Rehabilitation Using BFR

Traditional Therapy PROCEDURE

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

Rotator Cuff Rehabilitation Without BFR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-80 who suffered a rotator cuff tear
• Patients undergoing arthroscopic rotator cuff repair
• Patients undergoing nonoperative treatment with physical therapy

You may not qualify if:

• Subjects will be excluded if they are undergoing revision rotator cuff repair, history of DVT, neurovascular injury, unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Related Publications (10)

• Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.

  PMID: 21917016 BACKGROUND

• Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.

  PMID: 26446893 BACKGROUND

• Hamano N, Yamamoto A, Shitara H, Ichinose T, Shimoyama D, Sasaki T, Kobayashi T, Kakuta Y, Osawa T, Takagishi K. Does successful rotator cuff repair improve muscle atrophy and fatty infiltration of the rotator cuff? A retrospective magnetic resonance imaging study performed shortly after surgery as a reference. J Shoulder Elbow Surg. 2017 Jun;26(6):967-974. doi: 10.1016/j.jse.2016.10.016. Epub 2017 Feb 15.

  PMID: 28214172 BACKGROUND

• Kuzel BR, Grindel S, Papandrea R, Ziegler D. Fatty infiltration and rotator cuff atrophy. J Am Acad Orthop Surg. 2013 Oct;21(10):613-23. doi: 10.5435/JAAOS-21-10-613.

  PMID: 24084435 BACKGROUND

• Madarame H, Sasaki K, Ishii N. Endocrine responses to upper- and lower-limb resistance exercises with blood flow restriction. Acta Physiol Hung. 2010 Jun;97(2):192-200. doi: 10.1556/APhysiol.97.2010.2.5.

  PMID: 20511128 BACKGROUND

• Melis B, DeFranco MJ, Chuinard C, Walch G. Natural history of fatty infiltration and atrophy of the supraspinatus muscle in rotator cuff tears. Clin Orthop Relat Res. 2010 Jun;468(6):1498-505. doi: 10.1007/s11999-009-1207-x.

  PMID: 20094853 BACKGROUND

• Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.

  PMID: 19952261 BACKGROUND

• Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.

  PMID: 12635796 BACKGROUND

• Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.

  PMID: 11128848 BACKGROUND

• Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.

  PMID: 18466185 BACKGROUND

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Joseph Tramer
• Organization: Henry Ford Health

jtramer1@hfhs.org

2165362904

Study Officials

• Lafi S Khalil, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 12, 2020
• Study Start: June 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-06

Locations

US (1)