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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03032432
Recruitment Status : Withdrawn (Principle Investigator is no longer at Loma Linda University Medical Center)
First Posted : January 26, 2017
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date March 4, 2021
Actual Study Start Date  ICMJE June 12, 2018
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Short Form-36 [ Time Frame: 12 months ]
Short form Health questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Simple Shoulder Test [ Time Frame: 12 months ]
12 yes or no questions on function with the involved shoulder.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 24, 2017)
American Shoulder and Elbow Surgeons Shoulder Assessment (ASES) [ Time Frame: 12 months ]
Shoulder Function questionnaire
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Dynamic Elastic Garment (DEG) in Patients With Rotator Cuff Tendinopathy
Official Title  ICMJE 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.
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rotator Cuff Tendinopathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Dynamic elastic garment and injection
    Interventions:
    • Device: Dynamic Elastic Garment (DEG) brace
    • Drug: Corticosteroid injection
  • Active Comparator: Corticosteroid injection
    Intervention: Drug: Corticosteroid injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 2, 2021)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
60
Actual Study Completion Date  ICMJE February 15, 2019
Actual Primary Completion Date February 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032432
Other Study ID Numbers  ICMJE 5160465
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Loma Linda University
Study Sponsor  ICMJE Loma Linda University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nirav H Amin, MD Loma Linda University
PRS Account Loma Linda University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP