Scapular DyskinesisNCT05116722
Shoulder Pacemaker for Scapular Dyskinesia
A study testing Shoulder Pacemaker in people with Scapular Dyskinesis and Posterior Shoulder Instability, run by University of Utah at 1 site in United States.
Trial summary
The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Scapular Dyskinesis, Posterior Shoulder Instability
- What is being tested?
- Shoulder Pacemaker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2021to Sep 2028
- 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
- Scapular Dyskinesis
- Posterior Shoulder Instability
Who cannot join
- Rotator Cuff Tearing
- Shoulder Arthritis
- Patients with implantable electrical/electronic devices
- If participants are using wearable electrical medical devices, such as glucose sensors or infusion pumps, these devices will be turned off or the participants will be excluded from the study.
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 Center
Salt Lake City, Utah, 84108
About this study
Official title: Shoulder Pacemaker for the Treatment of Scapular Dyskinesia
The investigators purpose of this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker.
Read the detailed description
The scapula plays a key role in nearly every aspect of normal shoulder function. Shoulder dyskinesia or scapula winging effects patients as a result of nerve injury or muscle detachment or abnormal muscle recruitment. Patients with abnormal muscle recruitment often are helped the most by therapy but restoring normal firing can be difficult. Abnormal muscle recruitment is due to pain or weakness or instability of the glenohumeral joint and the muscles around the scapula attempt to compensate for the lack of normal firing patterns. In many patients, physical therapy and surgery have proven to be unsuccessful treatment options.
The Shoulder Pacemaker is a device that specifically aims at resolving functional issues that surgery and physical therapy are unable. It's a wearable electro stimulator created for patients suffering from unbalanced muscle activation in the shoulder, such as Scapular Dyskinesis. The Shoulder Pacemaker delivers "smart stimulation" through a dynamic interaction between the patient and the device. The motion technology recognizes muscle movement and automatically sets the appropriate stimulation intensity according to the movement. This process helps to restore normal muscle activation patterns and equilibrium. The pacemaker will hopefully assist in restoring normal muscle recruitment.
- Being tested
- Shoulder Pacemaker
- Keywords
- Scapular Dyskinesia, Posterior Shoulder Instability, Shoulder Pacemaker, Treatment, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoulder PacemakerDevice
Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Shoulder Pacemaker Treatment | Experimental | The patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy. Receives: Device: Shoulder Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Beginning of the study prior to initiating use of the pacemaker
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 3-months
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 6-months
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start27 Sep 2021
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scapular DyskinesisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Tashjian, University of Utah
- Investigators
- Robert Z Tashjian, MD, Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116722
- Sponsor's protocol ID
- 144053
- Status last verified
- Apr 2026
- First submitted
- 1 Nov 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shoulder Pacemaker for the Treatment of Scapular Dyskinesia
- ClinicalTrials.gov ID
- NCT05116722
- Acronym / sponsor ID
- 144053
- Keywords
- Scapular Dyskinesia, Posterior Shoulder Instability, Shoulder Pacemaker, Treatment, Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 11 Nov 2021 (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 this study is to determine patients-reported outcomes (VAS pain scores) in patients with Scapular Dyskinesis or Posterior Shoulder Instability who undergo rehabilitation with a shoulder pacemaker.
Detailed description
The scapula plays a key role in nearly every aspect of normal shoulder function. Shoulder dyskinesia or scapula winging effects patients as a result of nerve injury or muscle detachment or abnormal muscle recruitment. Patients with abnormal muscle recruitment often are helped the most by therapy but restoring normal firing can be difficult. Abnormal muscle recruitment is due to pain or weakness or instability of the glenohumeral joint and the muscles around the scapula attempt to compensate for the lack of normal firing patterns. In many patients, physical therapy and surgery have proven to be unsuccessful treatment options.
The Shoulder Pacemaker is a device that specifically aims at resolving functional issues that surgery and physical therapy are unable. It's a wearable electro stimulator created for patients suffering from unbalanced muscle activation in the shoulder, such as Scapular Dyskinesis. The Shoulder Pacemaker delivers "smart stimulation" through a dynamic interaction between the patient and the device. The motion technology recognizes muscle movement and automatically sets the appropriate stimulation intensity according to the movement. This process helps to restore normal muscle activation patterns and equilibrium. The pacemaker will hopefully assist in restoring normal muscle recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder Pacemaker Treatment | Experimental | Device: Shoulder PacemakerThe patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scapular Dyskinesis
- Posterior Shoulder Instability
Key exclusion criteria (4 listed)
- Rotator Cuff Tearing
- Shoulder Arthritis
- Patients with implantable electrical/electronic devices
- If participants are using wearable electrical medical devices, such as glucose sensors or infusion pumps, these devices will be turned off or the participants will be excluded from the study.
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 |
|---|---|---|
| Shoulder PacemakerShoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy. | Device | Shoulder Pacemaker Treatment |
Primary outcome
Visual Analog Scale (VAS) pain
Time frame: Beginning of the study prior to initiating use of the pacemaker
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 3-months
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 6-months
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 12-months
VAS pain score (0 no pain - 10 severe pain)
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 May 2026.
- Individual participant dataSharing planned: No
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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.
Robert Z Tashjian, MD 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 in people with Scapular Dyskinesis and Posterior Shoulder Instability, 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 2 inclusion and 4 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 May 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?
Visual Analog Scale (VAS) pain (time frame: Beginning of the study prior to initiating use of the pacemaker). The study lists 4 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 May 2026.