NCT05384093 · Foundation for Orthopaedic Research and Education
Outcomes of Treatment Using the ERMI Shoulder Flexionater ®
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
High Intensity Stretch Device
High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.
Primary outcome measures
Shoulder Range of Motion Improvement
Time frame: 3 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 6 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 12 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 24 months
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: 6 weeks
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
Shoulder Range of Motion
Time frame: baseline
Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice
VAS (Visual Analog Scale) Pain Score
Time frame: 3 months
Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 6 weeks
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 6 months
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 12 months
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: 24 months
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
VAS Pain Score
Time frame: baseline
Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be)
ASES Score
Time frame: baseline
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 3 month
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 6 weeks
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 6 months
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 12 months
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
ASES Score
Time frame: 24 months
American Shoulder and Elbow Society Score (10 activities of daily living are calculated)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Tampa, Florida
Collaborators
Ermi LLC
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 7, 2025 · Source of record for eligibility and locations