Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384093
• Other study ID #: FORE AC 2019
• Status: Recruiting
• Phase: N/A
• Start date: June 25, 2019
• Est. completion date: June 25, 2025

Study information

• Verified date: March 2024
• Source: Foundation for Orthopaedic Research and Education
• Contact: Deborah H Warren, RN
• Phone: 8139789700
• Email: dwarren[@]foreonline.org
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: June 25, 2025
• Est. primary completion date: October 25, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

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

Locations

Country	Name	City	State
United States	Foundation for Orthopaedic Research and Education	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education	ERMI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Range of Motion Improvement	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	3 months
Primary	Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	6 months
Primary	Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	12 months
Primary	Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	24 months
Primary	Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	6 weeks
Primary	Shoulder Range of Motion	Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice	baseline
Primary	VAS (Visual Analog Scale) Pain Score	Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)	3 months
Primary	VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	6 weeks
Primary	VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	6 months
Primary	VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	12 months
Primary	VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	24 months
Primary	VAS Pain Score	Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)	baseline
Primary	ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	baseline
Primary	ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	3 month
Primary	ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	6 weeks
Primary	ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	6 months
Primary	ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	12 months
Primary	ASES Score	American Shoulder and Elbow Society Score (10 activities of daily living are calculated)	24 months
Secondary	SST	Simple Shoulder Test	Baseline
Secondary	SST	Simple Shoulder Test	3 month
Secondary	SST	Simple Shoulder Test	6 weeks
Secondary	SST	Simple Shoulder Test	6 months
Secondary	SST	Simple Shoulder Test	12 months
Secondary	SST	Simple Shoulder Test	24 months
Secondary	Device Compliance Questionnaire (if applicable)	compliance with Device usage	6 weeks
Secondary	Device Compliance Questionnaire (if applicable)	compliance with Device usage	3 months
Secondary	Device Compliance Questionnaire (if applicable)	compliance with Device usage	6 months