Shoulder Pacemaker for Scapular Dyskinesia

Scapular Dyskinesis Clinical Trial

Official title:

Shoulder Pacemaker for the Treatment of Scapular Dyskinesia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05116722
• Other study ID #: 144053
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: September 2027

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyskinesias
• Scapular Dyskinesis

Intervention

Device:
• Shoulder Pacemaker
Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.

Locations

Country	Name	City	State
United States	University Of Utah Orthopedics Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	3-months
Primary	Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	6-months
Primary	Visual Analog Scale (VAS) pain	VAS pain score (0 no pain - 10 severe pain)	12-months