Shoulder Pacemaker for Shoulder Injuries

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Prior shoulder arthroplasty, Cardiac pacemaker, Neurologic injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research Team

Christopher Joyce, M.D.

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

This trial is for individuals who have had a reverse shoulder arthroplasty (RSA) and are undergoing rehabilitation. Participants should be suitable for post-operative rehab but cannot join if they have conditions that would interfere with the use of the Shoulder Pacemaker or adherence to physical therapy protocols.

Inclusion Criteria

Surgery at University of Utah Facilities

I am recommended to have surgery to replace my shoulder joint.

Exclusion Criteria

I have had shoulder replacement surgery on the same side before.

Prior cardiac pacemaker or spinal cord stimulator

I am unable or unwilling to follow the rehab program.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Post-operative Recovery

Participants undergo initial recovery after reverse shoulder arthroplasty before starting rehabilitation

6 weeks

Rehabilitation

Participants receive physical therapy with or without the Shoulder Pacemaker device

12 weeks

3 visits per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Shoulder Pacemaker

Trial Overview The study is testing whether using an FDA-approved device called the Shoulder Pacemaker, along with standard physical therapy, improves recovery after RSA compared to just standard physical therapy. The focus is on pain reduction and better movement and function.

Participant Groups

Group I: Shoulder pacemaker with physical therapy Experimental Treatment 1 Intervention

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.

Group II: Standard of care physical therapy Active Control 1 Intervention

Control group and will not use the shoulder pacemaker, but will participate in a standardized physical therapy protocol for 3 months.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+