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.
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
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
< 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
Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
Parallel
High Intensity Stretch Device
DeviceHigh Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
Shoulder Range of Motion Improvement
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
SST
Simple Shoulder Test
SST
Simple Shoulder Test
SST
Simple Shoulder Test
SST
Simple Shoulder Test
Click on the lead sponsor to view all of their trials.
Foundation for Orthopaedic Research and Education
Lead sponsor
Ermi LLC
Collaborator
