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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032432
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Brief 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.


Condition or disease Intervention/treatment Phase
Rotator Cuff Tendinopathy Device: Dynamic Elastic Garment (DEG) brace Drug: Corticosteroid injection Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : January 5, 2020
Estimated Study Completion Date : March 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dynamic elastic garment and injection Device: Dynamic Elastic Garment (DEG) brace
Improve function of the shoulder
Other Name: posture brace

Drug: Corticosteroid injection
Injection to improve rotator cuff tendinosis pain and functional score

Active Comparator: Corticosteroid injection Drug: Corticosteroid injection
Injection to improve rotator cuff tendinosis pain and functional score




Primary Outcome Measures :
  1. Short Form-36 [ Time Frame: 12 months ]
    Short form Health questionnaire


Secondary Outcome Measures :
  1. Simple Shoulder Test [ Time Frame: 12 months ]
    12 yes or no questions on function with the involved shoulder.


Other Outcome Measures:
  1. American Shoulder and Elbow Surgeons Shoulder Assessment (ASES) [ Time Frame: 12 months ]
    Shoulder Function questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032432


Contacts
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Contact: Nirav H Amin, M.D. 909-558-2808 ext 62699 NHAmin@llu.edu
Contact: Elisabeth Clarke, CRC 909-558-5592 ext 555 eaclarke@llu.edu

Locations
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United States, California
Loma Linda University Healthcare Department of Orthopaedic Surgery Recruiting
Loma Linda, California, United States, 92354
Contact: Elisabeth Clarke, CRC    909-558-5592 ext 55592    eaclarke@llu.edu   
Contact: Igor Kokhan, PhD    909-558-2808    ikokhan@llu.edu   
Principal Investigator: Nirav H. Amin, MD         
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Nirav H Amin, MD Loma Linda University
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Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT03032432    
Other Study ID Numbers: 5160465
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries