Clinical trial NCT05116722: Shoulder Pacemaker for Scapular Dyskinesia
Official title: Shoulder Pacemaker for the Treatment of Scapular Dyskinesia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Scapular Dyskinesis
Posterior Shoulder Instability
Keywords: Scapular Dyskinesia
Posterior Shoulder Instability
Shoulder Pacemaker
Treatment
Pain
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analog Scale (VAS) pain
timeFrame: Beginning of the study prior to initiating use of the pacemaker
measure: Visual Analog Scale (VAS) pain
timeFrame: 3-months
measure: Visual Analog Scale (VAS) pain
timeFrame: 6-months
measure: Visual Analog Scale (VAS) pain
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University Of Utah Orthopedics Center
state: Utah
Study officials:
affiliation: University of Utah Orthopaedics
name: Robert Z Tashjian, MD
role: PRINCIPAL_INVESTIGATOR
References: