Clinical Trial Radar

Name: Outcomes of Treatment Using the ERMI Shoulder Flexionater®
Creator: Foundation for Orthopaedic Research and Education
Published: 2022-05-20
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	Clinical Trial NCT05384093 for Adhesive Capsulitis of Shoulder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.

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Outcomes of Treatment Using the ERMI Shoulder Flexionater ® 210

Recruiting

Clinical Trial NCT05384093 is an interventional study for Adhesive Capsulitis of Shoulder that is recruiting. It started on June 25, 2019 with plans to enroll 210 participants. Led by Foundation for Orthopaedic Research and Education, it is expected to complete by June 25, 2026. The latest data from ClinicalTrials.gov was last updated on August 7, 2025.

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-opera...

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.

Prospective randomized control trial
Samp...

Official Title

Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Conditions

Adhesive Capsulitis of Shoulder

Publications

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;2...

Other Study IDs

FORE AC 2019

NCT ID Number

NCT05384093

Start Date (Actual)

2019-06-25

Last Update Posted

2025-08-07

Completion Date (Estimated)

2026-06-25

Enrollment (Estimated)

210

Study Type

Interventional

PHASE

N/A

Status

Recruiting

Primary Purpose

Treatment

Design Allocation

Randomized

Interventional Model

Parallel

Masking

None (Open Label)

Arms / Interventions

Participant Group/Arm	Intervention/Treatment
Active ComparatorAdhesive 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.	High Intensity Stretch Device High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
Active ComparatorPost 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.	High Intensity Stretch Device High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
Active ComparatorSecondary 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.	High Intensity Stretch Device High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.

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

Participation Assistant

Eligibility Criteria

Eligible Ages

Adult, Older Adult

Minimum Age

18 Years

Eligible Sexes

All

Accepts Healthy Volunteers

Yes

For Study Group 1- Adhesive Capsulitis (AC)

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

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?

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

Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)
ORIF Humerus fracture (23615)

For Study Group 3, Secondary Surgery Study (SAM)

Inclusion Criteria:
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

Manipulation under anesthesia (23700)
Lysis of adhesions (29825)

Foundation for Orthopaedic Research and Education

Ermi LLC

Study Central Contact

Contact: Deborah H Warren, RN, 8139789700, [email protected]

Contact: Viki Sochor, 813-978-9700, [email protected]

1 Study Locations in 1 Countries

United States

Florida

Foundation for Orthopaedic Research and Education, Tampa, Florida, 33607, United States

Deborah H Warren, Contact, 813-978-9700, [email protected]

Recruiting