Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- American Shoulder and Elbow Surgeons score
研究概览
简要总结
The investigators purpose of the proposed study is to use the FDA approved Shoulder Pacemaker device in patients undergoing reverse shoulder arthroplasty and study the functional outcomes compared to a standard post-operative rehabilitation program. The investigators hypothesize that use of the Shoulder Pacemaker reduce pain and will allow for improved range of motion and function in patients undergoing RSA. The findings of this research may very well improve function in RSA patients through a novel, non-invasive approach.
详细描述
The reverse shoulder arthroplasty (RSA) has increased utility in recent years for shoulder conditions such as rotator cuff tear arthropathy, massive irreparable rotator cuff tears, severe glenohumeral arthritis, proximal humerus fracture, and failed shoulder arthroplasty. While RSA may commonly be the only surgical treatment for some of these conditions, the outcomes and adverse event profiles are significant. Specifically, RSA patients often complain of poor range of motion and function with the arm above the head. Despite many attempts at solving these shortcomings with new implant design iterations and improved implant positioning, these continue to be a source of frustration with patients and surgeons alike.
Poor scapulothoracic motion is associated with poor shoulder range of motion, especially after RSA. Past investigators have shown that in certain RSA patients, there is a near complete loss of glenohumeral motion and forward elevation and abduction is highly dependent on scapulothoracic motion. In a separate study, In addition, these investigators demonstrated that internal rotation after RSA is largely dependent on scapulothoracic motion. Several years ago, a device called the Shoulder Pacemaker (Alyve Medical, Denver, CO) was developed initially for the treatment of functional instability in the setting of scapular dyskinesis. It functions as a wearable muscle electrostimulator that allows for periscapular muscle stimulation as well as feedback on shoulder range of motion. The motion technology recognizes muscle movement and automatically sets the appropriate stimulation intensity according to the movement. This improves scapular muscle recruitment during range of motion. While the data is limited, there has been some early promising results for this pathology. As function after RSA is particularly reliant on scapulothoracic function, the current investigators may infer that use of the Shoulder Pacemaker device may function well in patients with reverse shoulder replacements. Specifically, the device would allow patients to train their periscapular musculature after RSA to improve global shoulder motion and function. To the current investigators knowledge, there is no current research on the use of the Shoulder Pacemaker after RSA.
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
- None
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
- 否
入选标准
- •Patients indicated for primary reverse shoulder arthroplasty
- •Surgery at University of Utah Facilities
- •Patients between the ages 18-80.
排除标准
- •Prior ipsilateral shoulder arthroplasty
- •Inability or unwillingness to participate in the rehabilitation protocol
- •Prior cardiac pacemaker or spinal cord stimulator
- •Age over 80
- •History of periscapular surgery
- •History of ipsilateral neurologic injury
- •Prisoners
- •Patients requiring prolonged immobilization deviating from standard protocol
- •Patients who have an implantable medical device or other electrical device.
研究组 & 干预措施
Standard of care physical therapy
Control group and will not use the shoulder pacemaker, but will participate in a standardized physical therapy protocol for 3 months.
干预措施: Standard of care physical therapy (Other)
Shoulder pacemaker with physical therapy
Include a standardized physical therapy protocol with utilization of the Shoulder Pacemaker device 3 times per week over a 3-month period starting at 6 weeks post-operatively.
干预措施: Shoulder pacemaker with physical therapy (Device)
结局指标
主要结局
American Shoulder and Elbow Surgeons score
时间窗: 1 year after surgery
Shoulder specific scoring system out of 100. A patient-reported score with visual analog scale for pain and functional subscales ranging from 0 (worse pain and function loss) to 50 (no pain and excellent function). Both scores are summed for a maximum score of 100.
次要结局
未报告次要终点
研究者
Christopher Joyce
Principle Investigator
University of Utah
