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

NCT03032432 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-03-04

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tendinopathy

Interventions

DEVICE

Dynamic Elastic Garment (DEG) brace

Improve function of the shoulder

DRUG

Corticosteroid injection

Injection to improve rotator cuff tendinosis pain and functional score

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Nirav H Amin, MD · Loma Linda University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-12
Primary Completion
2019-02-15
Completion
2019-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03032432 on ClinicalTrials.gov