Status:
RECRUITING
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Lead Sponsor:
Foundation for Orthopaedic Research and Education
Collaborating Sponsors:
ERMI, LLC
Conditions:
Adhesive Capsulitis of Shoulder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study 1 - Adhesive Capsulitis Study - 110 patients The purpose of this study is to compare treatment of patients with symptoms of adhesive capsulitis, primary and secondary, between three groups: I) P...
Detailed Description
Study 1 - Adhesive Capsulitis Study (AC) Objective: The purpose of this study is to compare treatment efficacy of patients with symptoms of primary and secondary adhesive capsulitis between three gro...
Eligibility Criteria
Inclusion
- For Study Group 1- Adhesive Capsulitis (AC)
- 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
- 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?
- \< 15 degrees external rotation with arm at side at 6 weeks post-op
- OR \< 90 degrees forward flexion at 3 months post-op iii. Step 3 - Enroll patients that meet inclusion criteria and assign group
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 25 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05384093
Start Date
June 25 2019
End Date
June 25 2026
Last Update
August 7 2025
Active Locations (1)
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1
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States, 33607