Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT05116722

Shoulder Pacemaker for 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Utah Orthopedics Center

Salt Lake City, Utah, 84108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shoulder Pacemaker

Device

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

Primary outcomes

  1. Visual Analog Scale (VAS) pain

    Time frame: Beginning of the study prior to initiating use of the pacemaker

    VAS pain score (0 no pain - 10 severe pain)

  2. Visual Analog Scale (VAS) pain

    Time frame: 3-months

    VAS pain score (0 no pain - 10 severe pain)

  3. Visual Analog Scale (VAS) pain

    Time frame: 6-months

    VAS pain score (0 no pain - 10 severe pain)

  4. Visual Analog Scale (VAS) pain

    Time frame: 12-months

    VAS pain score (0 no pain - 10 severe pain)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Shoulder Pacemaker for the Treatment of Scapular Dyskinesia

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Nov 11, 2021
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.