Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

NCT ID: NCT05384093

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-25
• Study Completion Date: 2026-06-25

Brief 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.

Detailed 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 - 110 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 - 10 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

Conditions

Adhesive Capsulitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adhesive Capsulitis Study

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.

Group Type: ACTIVE_COMPARATOR

High Intensity Stretch Device

Intervention Type: DEVICE

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

Post operative Shoulder Stiffness Study

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.

Group Type: ACTIVE_COMPARATOR

High Intensity Stretch Device

Intervention Type: DEVICE

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

Secondary Surgery Study

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.

Group Type: ACTIVE_COMPARATOR

High Intensity Stretch Device

Intervention Type: DEVICE

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

Interventions

High Intensity Stretch Device

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

Intervention Type: DEVICE

Other Intervention Names

Physical Therapy

Eligibility Criteria

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

1. < 15 degrees external rotation with arm at side at 6 weeks post-op

3. Underwent a manipulation under anesthesia or a lysis of adhesions procedure

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)

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)

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ERMI, LLC

UNKNOWN

Sponsor Role: collaborator

Foundation for Orthopaedic Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Simon, PhD

Role: STUDY_DIRECTOR

Foundation for Orthopaedic Research and Education

Locations

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Deborah H Warren, RN

Role: CONTACT

dwarren@foreonline.org

8139789700 ext. 6766

Viki Sochor

Role: CONTACT

vsochor@foreonline.org

813-978-9700 ext. 6832

Facility Contacts

Deborah H Warren

Role: primary

dwarren@foreonline.org

813-978-9700 ext. 6766

References

Teytelbaum DE, Kumar NS, Dent CS, Neaville S, Warren DH, Simon P, Baker CE. Efficacy of a high-intensity home stretching device and traditional physical therapy in non-operative management of adhesive capsulitis - a prospective, randomized control trial. BMC Musculoskelet Disord. 2024 Apr 20;25(1):305. doi: 10.1186/s12891-024-07448-4.

Reference Type: DERIVED

PMID: 38643086 (View on PubMed)

Other Identifiers

FORE AC 2019

Identifier Type: -

Identifier Source: org_study_id