Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

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.

NCT Number	NCT05384093
Lead Sponsor	Foundation for Orthopaedic Research and Education Collaborators: Ermi LLC
Conditions	Adhesive Capsulitis of Shoulder
Enrollment	210 participants
Start Date	2019-06-25
Primary Completion	2025-10-25 (estimated)
Study Completion	2026-06-25 (estimated)
Updated on ClinicalTrials.gov	2025-08-07