Use of Blood Flow Restriction (BFR) Therapy in Patients With Rotator Cuff Tears Treated Nonoperatively or Operatively: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Strength
研究概览
简要总结
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.
详细描述
Patients who are seen in clinic for rotator cuff pathology will undergo treatment for their rotator cuff based on a shared-decision making process with the orthopedic surgeon, irrespective of this study. Once a treatment plan is in place, the patient will be introduced to this study and presented with the opportunity to participate. If the patient agrees, a formal consent process will take place in clinic and the patient will undergo initial, baseline testing of strength, range of motion, pain scores, and patient reported outcome scores.
Therefore patients will be either in the nonoperative arm or the operative arm of this study. Within each arm, patients will be randomized via computer to be placed in either the blood flow restriction (BFR) cohort or the traditional (non-BFR cohort). Patients will prospectively undergo rotator cuff rehabilitation using BFR or conventional therapy by physical therapists with extensive experience in rotator cuff rehabilitation who will undergo training on use of BFR.
The nonoperative group will be given identical rehabilitation protocols, with the only difference being the use of a BFR cuff during rehabilitation for the BFR cohort. Similarly, the operative group will be given identical rehabilitation protocols, with the only difference being the use of a BFR cuff during rehabilitation for the BFR cohort.
Patients undergoing operative rotator cuff repair (RCR) will undergo preoperative rehabilitation prior to surgery for two weeks. Due to limitations of health insurance coverage of physical therapy sessions, the two weeks of preoperative "prehab" will consist of a structured home exercise program that is taught to the patient by a physical therapist during one session and recorded on a physical therapy (PT) diary by the patient during the two weeks leading up to surgery. Patients will be provided video instruction and training on how to conduct the exercises and this will also be done with and without the use of BFR depending on group allocation (via randomization). Additionally, warning signs for BFR cuff intolerance such as increased pain, swelling, numbness/tingling of the arm will be communicated to the patient. Following surgery patients will immediately be started in a formal physical therapy regimen as an outpatient. Therapy will consist of a structured program progressing from range of motion, to strength training and then functional tests. Patients will remain in their allocated BFR or non-BFR group.
Protocol as follows, both groups will use the same protocol with the only difference being use of BFR:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged 18-80 who suffered a rotator cuff tear
- •Patients undergoing arthroscopic rotator cuff repair
- •Patients undergoing nonoperative treatment with physical therapy
排除标准
- •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
研究组 & 干预措施
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.
- Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy using blood flow restriction cuffs.
- Patients who elect for RCR will undergo preoperative and postoperative traditional therapy using blood flow restriction cuffs.
干预措施: Blood Flow Restriction Therapy (Device)
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.
- Patients who elect for nonoperative treatment of their rotator cuff tear will undergo traditional therapy without using blood flow restriction cuffs.
- Patients who elect for RCR will undergo preoperative and postoperative traditional therapy without using blood flow restriction cuffs.
干预措施: Traditional Therapy (Procedure)
结局指标
主要结局
Strength
时间窗: through study completion, an average of 12 months post-operative follow-up
Strength will be quantified through dynamometers
次要结局
- 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)
研究者
Vasilios Moutzouros
Orthopedic Surgeon
Henry Ford Health System