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

Phase 4

Terminated

• Conditions: Osteoarthritis of the Glenohumeral Joint
• Interventions: Procedure: intraarticular corticosteroid injections (IACSI); Drug: corticosteroid injections; Device: Ultrasound

• Registration Number: NCT03232749
• Lead Sponsor: University of Florida

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-28
• Study Start: 2018-04-18
• Primary Completion: 2019-06-06
• Study Completion: 2019-06-06
• Results First Submitted: 2021-01-27
• Results First Submitted QC: 2021-05-14
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Results First Posted: 2021-06-09
• Last Update Posted: 2021-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
symptomatic primary osteoarthritis of the shoulder	corticosteroid injections	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
symptomatic primary osteoarthritis of the shoulder	intraarticular corticosteroid injections (IACSI)	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
symptomatic primary osteoarthritis of the shoulder	Ultrasound	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

Primary Outcome Measures

Name	Time	Method
ASES Scores at Each Time Point	Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months	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).
Visual Analog Scale Scores at Each Time Point.	Baseline, post-injection (5-10 minutes), 2 weeks, 1 month, 2 months, 3 months, 6 months	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.
SST (Simple Shoulder Test) Scores at Each Time Point	Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months	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)

Trial Locations

Locations (2)

UF Health Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States

UF and Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States