RECRUITING

Outcomes of Treatment Using the ERMI Shoulder Flexionater ®

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Outcomes of Treatment Using the ERMI Shoulder Flexionater®

Quick Facts

Study Start:2019-06-25
Study Completion:2026-06-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05384093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  1. * 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

Contacts and Locations

Study Contact

Deborah H Warren, RN
CONTACT
8139789700
dwarren@foreonline.org
Viki Sochor
CONTACT
813-978-9700
vsochor@foreonline.org

Principal Investigator

Peter Simon, PhD
STUDY_DIRECTOR
Foundation for Orthopaedic Research and Education

Study Locations (Sites)

Foundation for Orthopaedic Research and Education
Tampa, Florida, 33607
United States

Collaborators and Investigators

Sponsor: Foundation for Orthopaedic Research and Education

  • Peter Simon, PhD, STUDY_DIRECTOR, Foundation for Orthopaedic Research and Education

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-25
Study Completion Date2026-06-25

Study Record Updates

Study Start Date2019-06-25
Study Completion Date2026-06-25

Terms related to this study

Additional Relevant MeSH Terms

  • Adhesive Capsulitis of Shoulder