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NCT03032432: DEG

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

Withdrawn Phase 4 Last updated 4 March 2021
What this trial tests

Phase 4 trial testing Dynamic Elastic Garment (DEG) brace in Rotator Cuff Tendinopathy. Withdrawn.

Timeline
12 June 2018
Primary endpoint
15 February 2019
15 February 2019

Quick facts

Lead sponsorLoma Linda University
PhasePhase 4
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Start date12 June 2018
Primary completion15 February 2019
Estimated completion15 February 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Loma Linda University

Who can join

Adults 18 to 89, any sex, with Rotator Cuff Tendinopathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. An Evaluation of the Rotator Cuff Repair Research Pipeline.
    Checketts JX, Scott J, Gordon J, Jones J, et al · · 2018 · cited 9× · PMID 30480012 · DOI 10.1177/2325967118805731

Verify or expand the search:

Other recruiting trials for Rotator Cuff Tendinopathy

Currently open trials in the same condition.

Other Loma Linda University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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