Rehabilitation With the Shoulder Pacemaker

NCT06501859 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 163105
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Injuries

Keywords

Reverse Shoulder Arthroplasty (RSA); Shoulder Pacemaker; Rehabilitation; Range of motion; Pain

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Standard of care physical therapy

ACTIVE COMPARATOR

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

Shoulder pacemaker with physical therapy

EXPERIMENTAL

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

Interventions

Standard of care physical therapy OTHER

Standard rehabilitation protocol for 3 months.

Standard of care physical therapy

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.

Shoulder pacemaker with physical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Orthopedics

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Shoulder Injuries; Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Christopher Joyce, M.D.

  University of Utah Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 2, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 29, 2025

Record last verified: 2025-10

Locations

US (1)