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Enrolling by Invitation

NCT Number: NCT06501859

Rehabilitation With the Shoulder Pacemaker

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.

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Key information

Conditions

Shoulder Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of care physical therapy

Other

Standard rehabilitation protocol for 3 months.

Shoulder pacemaker with physical therapy

Device

Standardized rehabilitation protocol with utilization of the shoulder pacemaker device 3 times per week over a 3-month period.

Primary outcomes

  1. American Shoulder and Elbow Surgeons score

    Time frame: Pre-operatively

    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.

  2. American Shoulder and Elbow Surgeons score

    Time frame: 6 weeks 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.

  3. American Shoulder and Elbow Surgeons score

    Time frame: 3 months 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.

  4. American Shoulder and Elbow Surgeons score

    Time frame: 6 months 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.

  5. American Shoulder and Elbow Surgeons score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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