Shoulder Pacemaker for Scapular Dyskinesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shoulder Pacemaker.
- Who it may be relevant to
- Registry conditions: Scapular Dyskinesis, Posterior Shoulder Instability. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Shoulder Pacemaker for the Treatment of Scapular Dyskinesia
Overview
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.
Interventions
- Device Shoulder Pacemaker
Shoulder pacemaker treatment for 15 - 30 minutes at 3-months, 6-months and 12-months during physical therapy.
Primary outcome measures
- Visual Analog Scale (VAS) pain [Time frame: Beginning of the study prior to initiating use of the pacemaker]
- Visual Analog Scale (VAS) pain [Time frame: 3-months]
- Visual Analog Scale (VAS) pain [Time frame: 6-months]
- Visual Analog Scale (VAS) pain [Time frame: 12-months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Of Utah Orthopedics Center — Salt Lake City
Identifiers
NCT: NCT05116722 · 144053