Shoulder InjuriesNCT06501859
Rehabilitation With the Shoulder Pacemaker
A study testing Shoulder pacemaker with physical therapy in people with Shoulder Injuries, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Injuries
- What is being tested?
- Shoulder pacemaker with physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients indicated for primary reverse shoulder arthroplasty
- Surgery at University of Utah Facilities
- Patients between the ages 18-80.
Who cannot join
- 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
Show all 9Show fewer
- Prisoners
- Patients requiring prolonged immobilization deviating from standard protocol
- Patients who have an implantable medical device or other electrical device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Utah Orthopedics
Salt Lake City, Utah, 84108
About this study
Official title: Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty
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.
Read the 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.
- Conditions
- Shoulder Injuries
- Being tested
- Standard of care physical therapy, Shoulder pacemaker with physical therapy
- Keywords
- Reverse Shoulder Arthroplasty (RSA), Shoulder Pacemaker, Rehabilitation, Range of motion, Pain
- Medical subject headings
- Shoulder Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care physical therapyOther
Standard rehabilitation protocol for 3 months.
Shoulder pacemaker with physical therapyDevice
Standardized rehabilitation protocol with utilization of the shoulder pacemaker device 3 times per week over a 3-month period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Shoulder pacemaker with physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start2 Aug 2023
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Joyce, University of Utah
- Investigators
- Christopher Joyce, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501859
- Sponsor's protocol ID
- 163105
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation With the Shoulder Pacemaker After Reverse Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06501859
- Acronym / sponsor ID
- 163105
- Conditions
- Shoulder Injuries
- Keywords
- Reverse Shoulder Arthroplasty (RSA), Shoulder Pacemaker, Rehabilitation, Range of motion, Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care physical therapy | Active comparator | Other: Standard of care physical therapyControl group and will not use the shoulder pacemaker, but will participate in a standardized physical therapy protocol for 3 months. |
| Shoulder pacemaker with physical therapy | Experimental | Device: Shoulder pacemaker with physical therapyInclude 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients indicated for primary reverse shoulder arthroplasty
- Surgery at University of Utah Facilities
- Patients between the ages 18-80.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care physical therapyStandard rehabilitation protocol for 3 months. | Other | Standard of care physical therapy |
| Shoulder pacemaker with physical therapyStandardized rehabilitation protocol with utilization of the shoulder pacemaker device 3 times per week over a 3-month period. | Device | Shoulder pacemaker with physical therapy |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Joyce, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shoulder pacemaker with physical therapy in people with Shoulder Injuries, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Shoulder and Elbow Surgeons score (time frame: Pre-operatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.