Shoulder Pacemaker for Scapular Dyskinesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Shoulder Pacemaker for the Treatment of Scapular Dyskinesia

Conditions
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Scapular Dyskinesis, Posterior Shoulder Instability

Intervention / Treatment
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* Device: Shoulder Pacemaker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scapular Dyskinesis Posterior Shoulder Instability Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shoulder Pacemaker Treatment<br>The patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy. | Device: Shoulder Pacemaker<br>* Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | 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) | 3-months | 
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | 6-months | 
| Visual Analog Scale (VAS) pain | VAS pain score (0 no pain - 10 severe pain) | 12-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scapular Dyskinesia, Posterior Shoulder Instability, Shoulder Pacemaker, Treatment, Pain