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



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 89
Updated:3/3/2019
Start Date:June 12, 2018
End Date:March 4, 2020
Contact:Nirav H Amin, M.D.
Email:NHAmin@llu.edu
Phone:909-558-2808

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A Single-blinded Randomized Controlled Trial Comparing Patients Who Receive a Corticosteroid Injection for Nontraumatic Degenerative Rotator Cuff Tears or Tendinopathy and Scheduled Use of a Dynamic Elastic Garment to Patients Who Receive a Corticosteroid Injection Alone.

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.

Shoulder pain is a common complaint with a reported prevalence of 7-26% in the general
population(1). The most common etiology of shoulder pain in the primary care setting is
rotator cuff disease (2-4), a term which encompasses several separate diagnoses. In an
orthopaedic practice, rotator cuff disease includes tendinosis or tendinitis of the
supraspinatus, infraspinatus, subscapularis, or teres minor tendons, subacromial impingement
with or without bursitis, bicipital tendinitis, or a partial or complete rotator cuff tear.
This study will specifically include patients with tendinosis or tendinitis of the rotator
cuff, for which we will use the term rotator cuff tendinopathy.

There are myriad treatment options for rotator cuff tendinopathy; from conservative measures
such as NSAIDs, corticosteroid injections, and physiotherapy to more invasive measures
including arthroscopic decompression for subacromial impingement syndrome. While most
orthopaedic surgeons will employ some combination of physiotherapy, NSAIDs, and
corticosteroid injections for pain relief, the evidence supporting their efficacy in
providing long-term pain relief and functional improvement is limited. Thus, there is
clinical equipoise that exists when treating rotator cuff tendinopathy has led physicians to
pursue other less traditional modalities. Some of these that have gained notoriety are
hyperthermia, extracorporeal shock-wave treatment, electrotherapy modalities and more
recently, non-elastic taping and elastic kinesiology taping.

Dynamic elastic garments are relatively new products which are being used to improve posture
and provide shoulder and lumbar support. Abnormal scapular motion, particularly scapular
protraction, has been shown to reduce the subacromial width and place undue strain on the
rotator cuff. These garments utilize elastic bands placed in specific locations to provide
postural support and proprioceptive feedback to the patient. This may help to restore normal
shoulder kinematics and subsequently provide relief of shoulder symptoms.

Patients with MRI-confirmed tendinosis or tendinopathy of the rotator cuff will have improved
shoulder pain relief and outcome scores when treated with scheduled use of a dynamic- elastic
garment and a corticosteroid injection compared to those patients who receive a
corticosteroid injection alone.

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.
We found this trial at
1
site
11234 Anderson Street
Loma Linda, California 92354
Principal Investigator: Nirav H. Amin, MD
Phone: 909-558-5592
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mi
from
Loma Linda, CA
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