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

Phase 4TerminatedNCT03232749

University of Florida25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Osteoarthritis of the Glenohumeral Joint

Interventions

intraarticular corticosteroid injections (IACSI)PROCEDURE

ultrasound-guided IACSI will be administered

corticosteroid injectionsDRUG

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

UltrasoundDEVICE

ultrasound-guided IACSI

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (2)

UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, United States

Outcomes

Primary Outcomes

ASES Scores at Each Time Point

ASES (American Shoulder \& Elbow Surgeon) score. Data points a change for all pre-specified time points and is reported. ASES has 11 items scored by Pain VAS (1 question) Function (10 questions); Score: 0-100 (Higher score is better).

Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Visual Analog Scale Scores at Each Time Point.

VAS (Visual Analog Scale) pain score improvement \> 1.4 points (The number that the respondent indicates on the scale to rate their pain intensity is recorded. Scores range from 0=no pain and 10=worst pain). The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0=no pain and 10=worst pain.

Time frame: Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months

SST (Simple Shoulder Test) Scores at Each Time Point

SST (Simple Shoulder Test) score improvement \> 2.4 points. 12 items that are answered yes/no (measures functional limitations of the affected shoulder): Scored: 0-12 (Higher score is better)

Time frame: Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Data from ClinicalTrials.gov

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