Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Launched by FOUNDATION FOR ORTHOPAEDIC RESEARCH AND EDUCATION · May 17, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new device called the ERMI Shoulder Flexionater® in treating shoulder stiffness caused by adhesive capsulitis, also known as frozen shoulder. The trial has three parts: one focuses on patients with adhesive capsulitis, another on those with stiffness after shoulder surgery, and the last on patients who have had a specific procedure to loosen their shoulder joint. Each part compares three treatment options: physical therapy alone, the device alone, and a combination of both.

To be eligible for the trial, participants need to have certain symptoms, like limited shoulder movement and pain, and must not have had prior shoulder surgery or specific medical conditions. If you join the study, you'll receive treatment according to the group you're assigned to, and you'll be monitored throughout the process. This trial is important because it aims to find out if the ERMI Shoulder Flexionater® can help improve shoulder movement and reduce pain more effectively than standard physical therapy alone.

Gender

ALL

Eligibility criteria

• • For Study Group 1- Adhesive Capsulitis (AC)
• Inclusion Criteria:
• • Exhibits symptoms of adhesive capsulitis i. Shoulder pain with limited motion for more than one month ii. AND ≤ 30 degrees external rotation with arm at side iii. AND ≤ 130 degrees forward flexion d. Cortisone shot for all patients
• Exclusion Criteria:
• • a. No prior shoulder surgery b. Infection c. Rheumatoid arthritis d. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
• • For Study Group 2 - Postoperative Shoulder Stiffness Study (POS)
• Inclusion Criteria:
• • c. Is not recovering normally based on objective criteria set for screening process i. Step 1 - Follow patients -all post-op patients with indicated procedures (see # 7 for list.) ii. Step 2 - Screen Patients -does patient meets inclusion criteria at 6 weeks or 3 months of follow-up?
• • 1. \< 15 degrees external rotation with arm at side at 6 weeks post-op
• • 2. OR \< 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group
• Exclusion Criteria:
• • a. Revision surgery b. Infection c. Rheumatoid arthritis
• • 7. Procedures included
• • 1. Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
• • 2. ORIF Humerus fracture (23615)
• • For Study Group 3, Secondary Surgery Study (SAM)
• Inclusion Criteria:
• • 3. Underwent a manipulation under anesthesia or a lysis of adhesions procedure
• Exclusion Criteria:
• • a. Infection b. Rheumatoid arthritis c. Any structural or systemic disorder that could result in pain or ROM limitation i. Such as inflammatory joint disease, osteoarthritis evidenced on radiographs ii. full thickness rotator cuff tear as shown by ultrasound imaging iii. history of major trauma or surgery involving the shoulder
• • 7. Procedures included
• • 1. Manipulation under anesthesia (23700)
• • 2. Lysis of adhesions (29825)