Actively Recruiting
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Led by Foundation for Orthopaedic Research and Education · Updated on 2025-08-07
210
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
Sponsors
F
Foundation for Orthopaedic Research and Education
Lead Sponsor
E
Ermi LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Study 2 - Postoperative Shoulder Stiffness Study - 90 patients The purpose of this study is to compare treatment of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device. Study 3 - Stiffness after MUA Study - enroll all eligible patients (goal of at least 15) The purpose of this study is to compare treatment of patients who have undergone manipulation under anesthesia or lysis of adhesions between three groups: I) Physical Therapy alone; II) ERMI Shoulder Flexionater® alone; III) PT + Device.
CONDITIONS
Official Title
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Who Can Participate
Eligibility Criteria
You may qualify if you...
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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Foundation for Orthopaedic Research and Education
Tampa, Florida, United States, 33607
Actively Recruiting
Research Team
D
Deborah H Warren, RN
CONTACT
V
Viki Sochor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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