Outcomes of Treatment Using the ERMI Shoulder Flexionater®
High Intensity Stretch Device
Bursitis
+ Joint Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: June 25, 2019
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.210 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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? 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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Foundation for Orthopaedic Research and Education
Tampa, United StatesOpen Foundation for Orthopaedic Research and Education in Google Maps