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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05384093
Other study ID # FORE AC 2019
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 25, 2019
Est. completion date June 25, 2025

Study information

Verified date March 2024
Source Foundation for Orthopaedic Research and Education
Contact Deborah H Warren, RN
Phone 8139789700
Email dwarren@foreonline.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 - 90 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 - 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


Recruitment information / eligibility

Status Recruiting
Enrollment 270
Est. completion date June 25, 2025
Est. primary completion date October 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
High Intensity Stretch Device
High Intensity Stretch and Physical Therapy are used either together or alone to treat study arm.

Locations

Country Name City State
United States Foundation for Orthopaedic Research and Education Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Foundation for Orthopaedic Research and Education ERMI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Shoulder Range of Motion Improvement Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice 3 months
Primary Shoulder Range of Motion Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice 6 months
Primary Shoulder Range of Motion Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice 12 months
Primary Shoulder Range of Motion Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice 24 months
Primary Shoulder Range of Motion Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice 6 weeks
Primary Shoulder Range of Motion Measuring Shoulder External Rotation and Forward Flexion using a goniometer according to standard practice baseline
Primary VAS (Visual Analog Scale) Pain Score Visual Analog Scale Pain Score 0 (no pain) - 10 (pain as bad as it can be) 3 months
Primary VAS Pain Score Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be) 6 weeks
Primary VAS Pain Score Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be) 6 months
Primary VAS Pain Score Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be) 12 months
Primary VAS Pain Score Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be) 24 months
Primary VAS Pain Score Visual Analog Scale Pain Score: 0 (no pain) - 10 (pain as bad as it can be) baseline
Primary ASES Score American Shoulder and Elbow Society Score (10 activities of daily living are calculated) baseline
Primary ASES Score American Shoulder and Elbow Society Score (10 activities of daily living are calculated) 3 month
Primary ASES Score American Shoulder and Elbow Society Score (10 activities of daily living are calculated) 6 weeks
Primary ASES Score American Shoulder and Elbow Society Score (10 activities of daily living are calculated) 6 months
Primary ASES Score American Shoulder and Elbow Society Score (10 activities of daily living are calculated) 12 months
Primary ASES Score American Shoulder and Elbow Society Score (10 activities of daily living are calculated) 24 months
Secondary SST Simple Shoulder Test Baseline
Secondary SST Simple Shoulder Test 3 month
Secondary SST Simple Shoulder Test 6 weeks
Secondary SST Simple Shoulder Test 6 months
Secondary SST Simple Shoulder Test 12 months
Secondary SST Simple Shoulder Test 24 months
Secondary Device Compliance Questionnaire (if applicable) compliance with Device usage 6 weeks
Secondary Device Compliance Questionnaire (if applicable) compliance with Device usage 3 months
Secondary Device Compliance Questionnaire (if applicable) compliance with Device usage 6 months
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