A Dynamic Elastic Garment (DEG) in Patients With Rotator Cuff Tendinopathy

• Status: Withdrawn
• Trial end date: 2019-02-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if patients with shoulder pain and MRI-confirmed rotator cuff tendinosis, will have their pain and function improved when treated with daily use of a dynamic elastic garment along with a corticosteroid injection, when compared to those patients who receive a corticosteroid injection alone. To our knowledge this is the first study to evaluate the use of a dynamic elastic garment on shoulders.

• Group A: Control group, will receive and ultrasound-guided corticosteroid injection alone.

• Group B: Intervention, ultrasound-guided corticosteroid injection and scheduled use of a dynamic elastic garment, by IntelliSkin.

• Group C: Intervention corticosteroid injection and scheduled use of a Dynamic elastic garment, by AlignMed Posture Shirt 2.0.

Up to 60 patients will participate and be randomized in this study, both male and female between the ages of 18 to 89 years of age. Subjects will complete a few forms; SF-36, ASES, Simple Shoulder test, these will take place at the initial visit and Then again at your 4 week and 6 week visit.

This is a single center study, investigator initiated. 60 subjects will participate in the study at Loma Linda University.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loma Linda University

Criteria

Inclusion Criteria:

• Patient over 18 to 89 years of age with MRI-confirmed tendinosis of the rotator cuff (supraspinatus, infraspinatus, subscapularis, or teres minor tendons) with pain on clinical examination

• Symptomatic, nontraumatic rotator cuff tears as confirmed on MRI

Exclusion Criteria:

• Traumatic onset of shoulder symptoms

• Evidence of symptomatic glenohumeral osteoarthritis (osteophytes on plain films with pain or stiffness on examination)

• Partial or complete rotator cuff tears

• Previous surgery on the affected shoulder

• History of rheumatoid arthritis or other systemic inflammatory disorder

• Use of immunosuppressive therapies in the last 6 months

• Inability to comply with or properly document use of dynamic elastic garment for prescribed time.