Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Adhesive Capsulitis of Shoulder Clinical Trial

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

Status Recruiting

Clinical Trial Summary

Study 1 - Adhesive Capsulitis Study - 90 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.

Clinical Trial 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 - 90 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 study - 2-year follow-up from last enrolled patient

Study 2 - Postoperative Shoulder Stiffness Study (POS)

Objective: The purpose of this study is to compare treatment efficacy of patients with post-operative stiffness indicative of secondary adhesive capsulitis between three groups: I) Patients treated with Physical Therapy alone; II) Patients treated with the ERMI Shoulder Flexionater® alone; III) Patients treated with PT + Device in the treatment.

1. Prospective randomized control trial

2. Sample size - 90 enrolled 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 study - 2-year follow-up from last enrolled patient

Study 3 - Secondary Surgery Study (SAM)

Objective: The purpose of this study is to compare recovery of patients who have undergone a manipulation under anesthesia or a lysis of adhesions 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 - 90 enrolled 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 study - 2-year follow-up from last enrolled patient ;

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

• NCT number: NCT05384093
• Study type: Interventional
• Source: Foundation for Orthopaedic Research and Education
• Contact: Deborah H Warren, RN
• Phone: 8139789700
• Email: dwarren@foreonline.org
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Completion date: June 25, 2025