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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Shoulder Pacemaker to determine if it aids recovery after reverse shoulder arthroplasty, a type of shoulder surgery. Researchers aim to discover whether using this device with physical therapy reduces pain and improves shoulder movement more effectively than physical therapy alone. The trial seeks participants scheduled for this specific shoulder surgery at University of Utah Facilities. Participants should not have had prior shoulder surgery on the same side and must be willing to follow the rehabilitation plan. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance recovery outcomes for future patients.

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.

What prior data suggests that the Shoulder Pacemaker is safe for patients undergoing reverse shoulder arthroplasty?

Research shows that the Shoulder Pacemaker is safe for aiding shoulder recovery. Earlier studies reported no serious issues such as wires moving out of place, blood pooling under the skin, or wound complications. This indicates that patients generally tolerate the device well. The FDA has also approved the Shoulder Pacemaker, providing additional assurance of its safety. Overall, evidence suggests that this device is a safe option for enhancing shoulder movement after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Shoulder Pacemaker is unique because it introduces a device-based approach to enhance recovery from shoulder injuries, unlike traditional methods that mainly rely on physical therapy alone. This innovative device is used alongside a physical therapy routine and is designed to stimulate shoulder muscles, potentially speeding up recovery and improving shoulder function more efficiently. Researchers are excited about the potential of the Shoulder Pacemaker to offer a more proactive and mechanical support to rehabilitation, which might lead to better outcomes for patients compared to standard physical therapy.

What evidence suggests that the Shoulder Pacemaker is effective for shoulder injuries?

Research shows that the Shoulder Pacemaker device can greatly improve shoulder movement and reduce pain. In this trial, participants in one arm will use the Shoulder Pacemaker alongside physical therapy, which studies have shown leads to quick improvements lasting over two years. When combined with physical therapy, this device aids recovery, resulting in better shoulder movement and less pain. Early results also suggest that the device complements traditional therapy, speeding up and enhancing recovery. Overall, the Shoulder Pacemaker appears promising for improving recovery from shoulder injuries. ^{1 2 6 7 8}

Who Is on the Research Team?

Christopher Joyce, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

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

Prior cardiac pacemaker or spinal cord stimulator

I am unable or unwilling to follow the rehab program.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11642471/

Efficacy of Shoulder Rehabilitation Post-Cardiac ... Conclusions: Shoulder rehabilitation therapy with successive education after CIED implantation significantly improved pain and shoulder function ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7364790/

Shoulder-Pacemaker Treatment Concept for Posterior ... The shoulder-pacemaker therapy concept is an effective treatment with rapid improvement and sustained outcome over the course of 2 years.

3. shoulderpacemaker.com shoulderpacemaker.com/sp/en/

NCS – Shoulder Pacemaker™ FAST SESSIONS. The Shoulder Pacemaker™ | Neuralign System S is efficient with an average of 30 to 50 minutes per session to augment and complement traditional ...

4. academic.oup.com academic.oup.com/ptj/article/104/1/pzad145/7327094

Neuromuscular Electrical Stimulation–Enhanced Physical ... ... results after physical therapy showed a significant improvement further underlining the effectiveness of the shoulder pacemaker treatment ...

5. isakos.com isakos.com/2023/Abstract/15783

2023 Congress in Boston, USA : Abstract Shoulder ... Shoulder Pacemaker-enhanced physiotherapy leads to significant and clinically relevant improvement of outcomes in the treatment of functional posterior shoulder ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/pace.14465

Efficacy and safety of different exercises in preventing ... showed that upper arm PEs are safe and effective in reducing the incidence of ROM reduction (from 40.4% to 16.8% for flexion and from 32.3% to ...

7. withpower.com withpower.com/trial/phase-shoulder-injuries-7-2023-74df1

Shoulder Pacemaker for Shoulder Injuries Trial Overview The study is testing whether using an FDA-approved device called the Shoulder Pacemaker, along with standard physical therapy, improves recovery ...

8. alyvemedical.com alyvemedical.com/news/alyve-medical-announces-publication-of-clinical-trial-on-neuralign-s-in-the-treatment-of-posterior-shoulder-instability/

Alyve Medical Announces Publication of Clinical Trial on ... The trial enrolled 49 patients with functional posterior shoulder instability across five high volume shoulder centers who were randomized to ...