Shoulder Pacemaker for Scapular Dyskinesia

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Scapular Dyskinesis; Posterior Shoulder Instability
• Intervention / Treatment: Device: 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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University Of Utah Orthopedics Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shoulder Pacemaker Treatment; 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; Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Robert Z Tashjian, MD, University of Utah Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Pain; Scapular Dyskinesia; Posterior Shoulder Instability; Shoulder Pacemaker
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias
• Other Study ID Numbers: 144053

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes