NCT05116722

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2021Sep 2028

Study Start

First participant enrolled

September 27, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

6.9 years

First QC Date

November 1, 2021

Last Update Submit

April 30, 2026

Conditions

Scapular DyskinesisPosterior Shoulder Instability

Keywords

Scapular DyskinesiaPosterior Shoulder InstabilityShoulder PacemakerTreatmentPain

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Shoulder Pacemaker Treatment

EXPERIMENTAL

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

Interventions

Shoulder PacemakerDEVICE

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

Shoulder Pacemaker Treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scapular Dyskinesis
  • Posterior Shoulder Instability

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Utah Orthopedics Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert Z Tashjian, MD

    University of Utah Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 11, 2021

Study Start

September 27, 2021

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)