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Enrolling by invitation NCT06501859

Rehabilitation With the Shoulder Pacemaker

No phase Interventional Shoulder Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard of care physical therapy, Shoulder pacemaker with physical therapy.
Who it may be relevant to
Registry conditions: Shoulder Injuries. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty

Overview

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.

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.

Interventions

  • Other Standard of care physical therapy
    Standard rehabilitation protocol for 3 months.
  • 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.

Primary outcome measures

  • American Shoulder and Elbow Surgeons score [Time frame: Pre-operatively]
  • American Shoulder and Elbow Surgeons score [Time frame: 6 weeks after surgery]
  • American Shoulder and Elbow Surgeons score [Time frame: 3 months after surgery]
  • American Shoulder and Elbow Surgeons score [Time frame: 6 months after surgery]
  • American Shoulder and Elbow Surgeons score [Time frame: 1 year after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Utah Orthopedics — Salt Lake City

Identifiers

NCT: NCT06501859 · 163105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗