Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Not Applicable

Recruiting

• Conditions: Adhesive Capsulitis of Shoulder
• Interventions: Device: High Intensity Stretch Device

• Registration Number: NCT05384093
• Lead Sponsor: Foundation for Orthopaedic Research and Education

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

Study Timeline

• Study Start: 2019-06-25
• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-17
• Study First Posted: 2022-05-20
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-10-25
• Study Completion: 2026-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Read More

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

8. Shoulder arthroscopic procedures (29827, 29828, 29823,29824, 29826)

9. ORIF Humerus fracture (23615)

   For Study Group 3, Secondary Surgery Study (SAM)

   Inclusion Criteria:

10. 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

8. Manipulation under anesthesia (23700)

9. Lysis of adhesions (29825)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adhesive Capsulitis Study	High Intensity Stretch Device	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.
Secondary Surgery Study	High Intensity Stretch Device	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.
Post operative Shoulder Stiffness Study	High Intensity Stretch Device	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
SST	24 months	Simple Shoulder Test
Device Compliance Questionnaire (if applicable)	6 months	compliance with Device usage

Trial Locations

Locations (1)

Foundation for Orthopaedic Research and Education; 🇺🇸 Tampa, Florida, United States