Rehabilitation With the Shoulder Pacemaker

Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Shoulder Injuries
• Intervention / Treatment: Other: Standard of care physical therapy; Device: Shoulder pacemaker with physical therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients indicated for primary reverse shoulder arthroplasty
• Surgery at University of Utah Facilities
• Patients between the ages 18-80.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Standard of care physical therapy; Standard rehabilitation protocol for 3 months.
Experimental: 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.	Device: Shoulder pacemaker with physical therapy; Standardized rehabilitation protocol with utilization of the shoulder pacemaker device 3 times per week over a 3-month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
American Shoulder and Elbow Surgeons score	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.	Pre-operatively
American Shoulder and Elbow Surgeons score	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.	6 weeks after surgery
American Shoulder and Elbow Surgeons score	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.	3 months after surgery
American Shoulder and Elbow Surgeons score	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.	6 months after surgery
American Shoulder and Elbow Surgeons score	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.	1 year after surgery

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Christopher Joyce, M.D., University of Utah Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Pain; Range of motion; Shoulder Pacemaker; Reverse Shoulder Arthroplasty (RSA)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Wounds and Injuries; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Shoulder Injuries; Pain; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: 163105

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No