Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint

NCT ID: NCT03232749

Last Updated: 2021-06-14

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-18

Study Completion Date

2019-06-06

Brief Summary

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This study will examine the effectiveness of a single cortisone injection in patients with shoulder osteoarthritis over a 6-month period, and identify clinical and radiographic factors to help predict how a patient with shoulder osteoarthritis will respond to a cortisone injection utilizing ultrasound guidance.

Detailed Description

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The purpose of this study is to assess the effectiveness of intraarticular corticosteroid injections (IACSI) for glenohumeral arthritis by 1) through patient-reported outcomes and 2) identifying clinical and radiographic predictors of IACSI success.

Conditions

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Osteoarthritis of the Glenohumeral Joint

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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symptomatic primary osteoarthritis of the shoulder

Subjects enrolled into the study will be those who have failed previous treatment including over-the-counter analgesics and activity modification, and have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder

Group Type OTHER

intraarticular corticosteroid injections (IACSI)

Intervention Type PROCEDURE

ultrasound-guided IACSI will be administered

corticosteroid injections

Intervention Type DRUG

Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder

Ultrasound

Intervention Type DEVICE

ultrasound-guided IACSI

Interventions

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intraarticular corticosteroid injections (IACSI)

ultrasound-guided IACSI will be administered

Intervention Type PROCEDURE

corticosteroid injections

Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder

Intervention Type DRUG

Ultrasound

ultrasound-guided IACSI

Intervention Type DEVICE

Other Intervention Names

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Methylprednisolone, Depo-medrol

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of symptomatic primary osteoarthritis of the shoulder will be recruited from the patient population seeking treatment at the Orthopaedics Sports Medicine Institute.
* those who have failed previous treatment including over-the-counter analgesics and activity modification
* have elected to receive a medically-indicated, ultrasound-guided IACSI in the shoulder.

Exclusion Criteria

* Patients will be excluded from the study for any of the following reasons:
* Post traumatic osteoarthritis
* Inflammatory osteoarthritis
* Imaging confirmed rotator cuff tear
* Prior ipsilateral shoulder surgery
* Memory loss or inability to complete study measures
* History of allergy to injection medications
* Diabetic patients with patient-reported fasting blood glucose \>200
* Prior injection in the ipsilateral shoulder within three months
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradley Schoch, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty

Locations

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UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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OCR18320

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201700603-A

Identifier Type: -

Identifier Source: org_study_id

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