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BFR Therapy in Patients With Rotator Cuff Tears

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ClinicalTrials.gov Identifier: NCT04384120
Recruitment Status : Not yet recruiting
First Posted : May 12, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Lafi Khalil, Henry Ford Health System

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.


Condition or disease Intervention/treatment Phase
Blood Flow Restriction Device: Blood Flow Restriction Therapy Procedure: Traditional Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Blood Flow Restriction (BFR) Therapy in Patients With Rotator Cuff Tears Treated Nonoperatively or Operatively: a Randomized Controlled Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Rotator Cuff Rehabilitation Using BFR

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
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.

Active Comparator: Rotator Cuff Rehabilitation Without BFR

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




Primary Outcome Measures :
  1. Strength [ Time Frame: through study completion, an average of 12 months post-operative follow-up ]
    Strength will be quantified through dynamometers


Secondary Outcome Measures :
  1. Range of Motion [ Time Frame: through study completion, an average of 12 months post-operative follow-up ]
    Range of motion of the shoulder will be assessed using a goniometer

  2. Pain Score [ Time Frame: 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

  3. Patient reported outcomes measurement information system [ Time Frame: 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.

  4. Rotator Cuff Integrity [ Time Frame: through study completion, an average of 12 months post-operative follow-up ]
    Fatty infiltration and muscle atrophy of the rotator cuff will be measured by ultrasound and compared to preoperative imaging

  5. ASES Outcome Score [ Time Frame: through study completion, an average of 12 months post-operative follow-up ]
    American shoulder and elbow surgeons standardized shoulder assessment form is a 100-point scale that consists of a pain scale worth 50 points and ten activities of daily living worth 50 points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • o 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384120


Contacts
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Contact: Lafi S Khalil, MD 313-932-5657 lkhalil2@hfhs.org
Contact: Joseph S Tramer, MD 216-536-2904 jtramer1@hfhs.org

Locations
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United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Lafi S Khalil, MD Henry Ford Health System
Publications:

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Responsible Party: Lafi Khalil, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT04384120    
Other Study ID Numbers: 13130
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: per request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries