Outcomes of Treatment Using the ERMI Shoulder Flexionater®
Foundation for Orthopaedic Research and Education
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) 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.
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 groups: 1) Patients treated with Physical Therapy alone; 2) Patients treated with the ERMI Shoulder Flexionater® alone; 3) Patients treated with PT + Device in the treatment. 1. Prospective randomized control trial 2. Sample size - 110 patients 3. Study Groups: 1. Group I - Physical Therapy Only 2. Group II - Flexionater® only 3. Group III - Flexionater® and Physical Therapy 4. Length of s…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DeviceHigh Intensity Stretch Device
High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
Location
- Foundation for Orthopaedic Research and EducationTampa, Florida