跳至主要内容
临床试验/NCT06501859
NCT06501859Enrolling By Invitation不适用

Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty

University of Utah2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月2日最近更新:
适应症
干预措施

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

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

Active Comparator

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Joyce

Principle Investigator

University of Utah

研究点 (2)

Loading locations...

相似试验