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RECRUITING

NCT05384093

Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Sponsor: Foundation for Orthopaedic Research and Education

View on ClinicalTrials.gov

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.

Official title: Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2019-06-25

Completion Date

2026-06-25

Last Updated

2025-08-07

Healthy Volunteers

Yes

Conditions

Adhesive Capsulitis of Shoulder

Interventions

DEVICE

High Intensity Stretch Device

High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.

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)

Locations (1)

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States