Blood Flow Restriction Clinical Trial
Official title:
Use of Blood Flow Restriction (BFR) Therapy in Patients With Rotator Cuff Tears Treated Nonoperatively or Operatively: a Randomized Controlled Trial
NCT number | NCT04384120 |
Other study ID # | 13130 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | July 2022 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Henry Ford Health Systems | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Henry Ford Health System |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Strength | Strength will be quantified through dynamometers | through study completion, an average of 12 months post-operative follow-up | |
Secondary | Range of Motion | Range of motion of the shoulder will be assessed using a goniometer | through study completion, an average of 12 months post-operative follow-up | |
Secondary | Pain Score | Pain will be assessed using a visual analogue scale (VAS), a pain scale from 0-10 where higher numbers indicate worse pain | through study completion, an average of 12 months post-operative follow-up | |
Secondary | Patient reported outcomes measurement information system | 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. | through study completion, an average of 12 months post-operative follow-up | |
Secondary | Rotator Cuff Integrity | Fatty infiltration and muscle atrophy of the rotator cuff will be measured by ultrasound and compared to preoperative imaging | through study completion, an average of 12 months post-operative follow-up | |
Secondary | ASES Outcome Score | 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. | through study completion, an average of 12 months post-operative follow-up |
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