Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Sample size - 90 patients Study Groups: Group I - Physical Therapy Only Group II - Flexionater® only Group III - Flexionater® and Physical Therapy 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. Prospective randomized control trial Sample size - 90 enrolled patients Study Groups: Group I - Physical Therapy only Group II - Flexionater® only Group III - Flexionater® and Physical Therapy 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. Prospective randomized control trial Sample size - 90 enrolled patients Study Groups: Group I Physical Therapy Only Group II - - Flexionater® only Group III - Flexionater® and Physical Therapy Length of study - 2-year follow-up from last enrolled patient

Official Title
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Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Conditions
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Adhesive Capsulitis of Shoulder

Intervention / Treatment
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* Device: High Intensity Stretch Device


Participation Criteria
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Eligibility Criteria
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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? < 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Adhesive Capsulitis Study<br>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<br>* High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.<br>* Other names: Physical Therapy;|
| Active Comparator: Post operative Shoulder Stiffness Study<br>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<br>* High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.<br>* Other names: Physical Therapy;|
| Active Comparator: Secondary Surgery Study<br>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<br>* High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.<br>* Other names: Physical Therapy;|

What is the study measuring?
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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 |