RecruitingNot ApplicableNCT05384093

Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Sponsor

Foundation for Orthopaedic Research and Education

Enrollment

210 participants

Start Date

Jun 25, 2019

Study Type

INTERVENTIONAL

Conditions

Adhesive capsulitis of shoulder

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks outcomes in patients using the ERMI Shoulder Flexionater, a device designed to help restore shoulder movement in three different groups: (1) people with adhesive capsulitis (frozen shoulder), (2) people with stiffness after shoulder surgery, and (3) people who had a secondary procedure (like manipulation under anesthesia) to treat shoulder stiffness. You may be eligible if (Adhesive Capsulitis group): - You are 18 or older - You have shoulder pain and limited motion for more than a month - Your shoulder external rotation is 30 degrees or less, or forward flexion is 130 degrees or less - You have received a cortisone injection You may be eligible if (Post-surgery group): - You had certain shoulder surgeries and your motion is not recovering as expected at 6 weeks or 3 months post-op You may be eligible if (Secondary surgery group): - You had a manipulation under anesthesia or lysis of adhesions procedure for shoulder stiffness You may NOT be eligible if: - You have had prior shoulder surgery (for frozen shoulder group only) - You have a joint infection - You have rheumatoid arthritis - You have a full-thickness rotator cuff tear - You have a history of major trauma or other structural shoulder disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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