Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

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.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Device: High Intensity Stretch 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

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deborah H Warren, RN; Phone Number: 6766 8139789700; Email: dwarren@foreonline.org
• Study Contact Backup: Name: Viki Sochor; Phone Number: 6832 813-978-9700; Email: vsochor@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Foundation for Orthopaedic Research and Education
      • Contact: Deborah H Warren; Phone Number: 6766 813-978-9700; Email: dwarren@foreonline.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: High Intensity Stretch Device; High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.; Other Names: Physical Therapy
Active Comparator: 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.	Device: High Intensity Stretch Device; High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.; Other Names: Physical Therapy
Active Comparator: 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.	Device: High Intensity Stretch Device; High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.; Other Names: Physical Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Range of Motion Improvement	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	3 months
Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	6 months
Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	12 months
Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	24 months
Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	6 weeks
Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	baseline
VAS (Visual Analog Scale) Pain Score	Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)	3 months
VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	6 weeks
VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	6 months
VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	12 months
VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	24 months
VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	baseline
ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	baseline
ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	3 month
ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	6 weeks
ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	6 months
ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	12 months
ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SST	Simple Shoulder Test	Baseline
SST	Simple Shoulder Test	3 month
SST	Simple Shoulder Test	6 weeks
SST	Simple Shoulder Test	6 months
SST	Simple Shoulder Test	12 months
SST	Simple Shoulder Test	24 months
Device Compliance Questionnaire (if applicable)	compliance with Device usage	6 weeks
Device Compliance Questionnaire (if applicable)	compliance with Device usage	3 months
Device Compliance Questionnaire (if applicable)	compliance with Device usage	6 months

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: ERMI, LLC
• Investigators: Study Director: Peter Simon, PhD, Foundation for Orthopaedic Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Estimated): October 25, 2025
• Study Completion (Estimated): June 25, 2026

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 17, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Bursitis
• Other Study ID Numbers: FORE AC 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: unknown at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes