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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis of the Glenohumeral Joint
• Intervention / Treatment: Procedure: intraarticular corticosteroid injections (IACSI); Drug: corticosteroid injections; Device: Ultrasound

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • UF and Shands Orthopaedics and Sports Medicine Institute
    • Gainesville, Florida, United States, 32611
      • UF Health Orthopaedics and Sports Medicine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Procedure: intraarticular corticosteroid injections (IACSI); ultrasound-guided IACSI will be administered; Drug: corticosteroid injections; Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder; Other Names: Methylprednisolone, Depo-medrol; Device: Ultrasound; ultrasound-guided IACSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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)	Baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Bradley Schoch, M.D., Faculty

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2018
• Primary Completion (Actual): June 6, 2019
• Study Completion (Actual): June 6, 2019

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 28, 2017

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Methylprednisolone Acetate; Methylprednisolone
• Other Study ID Numbers: IRB201700603-A; OCR18320 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes