Back to resultsOutcomes of Treatment Using the ERMI Shoulder Flexionater ®
Primary Purpose
Adhesive Capsulitis of Shoulder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Stretch Device
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis of Shoulder
Eligibility Criteria
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)
Sites / Locations
- Foundation for Orthopaedic Research and EducationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Adhesive Capsulitis Study
Post operative Shoulder Stiffness Study
Secondary Surgery Study
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Shoulder Range of Motion Improvement
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
VAS (Visual Analog Scale) Pain Score
Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Secondary Outcome Measures
SST
Simple Shoulder Test
SST
Simple Shoulder Test
SST
Simple Shoulder Test
SST
Simple Shoulder Test
SST
Simple Shoulder Test
SST
Simple Shoulder Test
Device Compliance Questionnaire (if applicable)
compliance with Device usage
Device Compliance Questionnaire (if applicable)
compliance with Device usage
Device Compliance Questionnaire (if applicable)
compliance with Device usage
Full Information
NCT ID
NCT05384093
First Posted
May 3, 2022
Last Updated
July 13, 2022
Sponsor
Foundation for Orthopaedic Research and Education
Collaborators
ERMI, LLC
1. Study Identification
Unique Protocol Identification Number
NCT05384093
Brief Title
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
Official Title
Outcomes of Treatment Using the ERMI Shoulder Flexionater®
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2019 (Actual)
Primary Completion Date
June 25, 2024 (Anticipated)
Study Completion Date
June 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation for Orthopaedic Research and Education
Collaborators
ERMI, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adhesive Capsulitis Study
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Post operative Shoulder Stiffness Study
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Secondary Surgery Study
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Intensity Stretch Device
Other Intervention Name(s)
Physical Therapy
Intervention Description
High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
Primary Outcome Measure Information:
Title
Shoulder Range of Motion Improvement
Description
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Time Frame
3 months
Title
Shoulder Range of Motion
Description
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Time Frame
6 months
Title
Shoulder Range of Motion
Description
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Time Frame
12 months
Title
Shoulder Range of Motion
Description
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Time Frame
24 months
Title
Shoulder Range of Motion
Description
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Time Frame
6 weeks
Title
Shoulder Range of Motion
Description
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Time Frame
baseline
Title
VAS (Visual Analog Scale) Pain Score
Description
Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)
Time Frame
3 months
Title
VAS Pain Score
Description
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Time Frame
6 weeks
Title
VAS Pain Score
Description
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Time Frame
6 months
Title
VAS Pain Score
Description
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Time Frame
12 months
Title
VAS Pain Score
Description
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Time Frame
24 months
Title
VAS Pain Score
Description
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
Time Frame
baseline
Title
ASES Score
Description
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Time Frame
baseline
Title
ASES Score
Description
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Time Frame
3 month
Title
ASES Score
Description
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Time Frame
6 weeks
Title
ASES Score
Description
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Time Frame
6 months
Title
ASES Score
Description
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Time Frame
12 months
Title
ASES Score
Description
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
SST
Description
Simple Shoulder Test
Time Frame
Baseline
Title
SST
Description
Simple Shoulder Test
Time Frame
3 month
Title
SST
Description
Simple Shoulder Test
Time Frame
6 weeks
Title
SST
Description
Simple Shoulder Test
Time Frame
6 months
Title
SST
Description
Simple Shoulder Test
Time Frame
12 months
Title
SST
Description
Simple Shoulder Test
Time Frame
24 months
Title
Device Compliance Questionnaire (if applicable)
Description
compliance with Device usage
Time Frame
6 weeks
Title
Device Compliance Questionnaire (if applicable)
Description
compliance with Device usage
Time Frame
3 months
Title
Device Compliance Questionnaire (if applicable)
Description
compliance with Device usage
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah H Warren, RN
Phone
8139789700
Ext
6766
Email
dwarren@foreonline.org
First Name & Middle Initial & Last Name or Official Title & Degree
Viki Gavulova
Phone
813-978-9700
Ext
6832
Email
vgavulova@foreonline.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Simon, PhD
Organizational Affiliation
Foundation for Orthopaedic Research and Education
Official's Role
Study Director
Facility Information:
Facility Name
Foundation for Orthopaedic Research and Education
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah H Warren
Phone
813-978-9700
Ext
6766
Email
dwarren@foreonline.org
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
unknown at this time
Learn more about this trial
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
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