Shoulder Pacemaker for Scapular Dyskinesia
Primary Purpose
Scapular Dyskinesis, Posterior Shoulder Instability
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoulder Pacemaker
Sponsored by
About this trial
This is an interventional treatment trial for Scapular Dyskinesis focused on measuring Scapular Dyskinesia, Posterior Shoulder Instability, Shoulder Pacemaker, Treatment, Pain
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.
Sites / Locations
- University Of Utah Orthopedics Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Shoulder Pacemaker Treatment
Arm Description
The patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.
Outcomes
Primary Outcome Measures
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Secondary Outcome Measures
Full Information
NCT ID
NCT05116722
First Posted
November 1, 2021
Last Updated
September 29, 2023
Sponsor
University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT05116722
Brief Title
Shoulder Pacemaker for Scapular Dyskinesia
Official Title
Shoulder Pacemaker for the Treatment of Scapular Dyskinesia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scapular Dyskinesis, Posterior Shoulder Instability
Keywords
Scapular Dyskinesia, Posterior Shoulder Instability, Shoulder Pacemaker, Treatment, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shoulder Pacemaker Treatment
Arm Type
Experimental
Arm Description
The patients will be treated using the pacemaker for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.
Intervention Type
Device
Intervention Name(s)
Shoulder Pacemaker
Intervention Description
Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
Beginning of the study prior to initiating use of the pacemaker
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
3-months
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
6-months
Title
Visual Analog Scale (VAS) pain
Description
VAS pain score (0 no pain - 10 severe pain)
Time Frame
12-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Z Tashjian, MD
Organizational Affiliation
University of Utah Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Utah Orthopedics Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shoulder Pacemaker for Scapular Dyskinesia
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