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

NCT03032432 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 5160465
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tendinopathy

Outcome Measures

Primary Outcomes (1)

• Short Form-36

  Short form Health questionnaire

  12 months

Secondary Outcomes (1)

• Simple Shoulder Test

  12 months

Other Outcomes (1)

• American Shoulder and Elbow Surgeons Shoulder Assessment (ASES)

  12 months

Study Arms (2)

Dynamic elastic garment and injection

EXPERIMENTAL

Device: Dynamic Elastic Garment (DEG) brace; Drug: Corticosteroid injection

Corticosteroid injection

ACTIVE COMPARATOR

Drug: Corticosteroid injection

Interventions

Dynamic Elastic Garment (DEG) brace DEVICE

Improve function of the shoulder

Also known as: posture brace

Dynamic elastic garment and injection

Corticosteroid injection DRUG

Injection to improve rotator cuff tendinosis pain and functional score

Corticosteroid injection; Dynamic elastic garment and injection

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Healthcare Department of Orthopaedic Surgery

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Braces; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Nirav H Amin, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 26, 2017
• Study Start: June 12, 2018
• Primary Completion: February 15, 2019
• Study Completion: February 15, 2019
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)