Comparing treatments for shoulder stiffness using a special device

Outcomes of Treatment Using the ERMI Shoulder Flexionater®

This study is testing a special device called the ERMI Shoulder Flexionater® to see if it helps people with shoulder stiffness feel better compared to regular physical therapy or a mix of both treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Foundation for Orthopaedic Research and Education (Academic / other)
• Locations: 1 site (Tampa, Florida)
• Trial ID: NCT05384093 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of the ERMI Shoulder Flexionater® in treating adhesive capsulitis of the shoulder by comparing it with traditional physical therapy and a combination of both. It consists of three separate studies focusing on different patient groups: those with primary and secondary adhesive capsulitis, patients experiencing postoperative stiffness, and individuals recovering from manipulation under anesthesia. Each group will be randomly assigned to one of three treatment options: physical therapy alone, the Flexionater® alone, or a combination of both, with a follow-up period of two years. The goal is to determine which treatment approach yields the best outcomes for shoulder mobility and pain relief.

Who should consider this trial

Good fit: Ideal candidates include individuals experiencing symptoms of adhesive capsulitis or postoperative stiffness in the shoulder.

Not a fit: Patients with prior shoulder surgery, infections, or other structural disorders affecting shoulder mobility may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with more effective treatment options for shoulder stiffness and improve their recovery outcomes.

How similar studies have performed: While the use of devices for shoulder rehabilitation is common, the specific application of the ERMI Shoulder Flexionater® in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

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)

Where this trial is running

Tampa, Florida

• Foundation for Orthopaedic Research and Education — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Deborah H Warren, RN

Conditions Adhesive Capsulitis of Shoulder