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

NCT03232749 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: IRB201700603-AOCR18320
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis of the Glenohumeral Joint

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

symptomatic primary osteoarthritis of the shoulder

OTHER

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); Drug: corticosteroid injections; Device: Ultrasound

Interventions

intraarticular corticosteroid injections (IACSI) PROCEDURE

ultrasound-guided IACSI will be administered

symptomatic primary osteoarthritis of the shoulder

corticosteroid injections DRUG

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

Also known as: Methylprednisolone, Depo-medrol

symptomatic primary osteoarthritis of the shoulder

Ultrasound DEVICE

ultrasound-guided IACSI

symptomatic primary osteoarthritis of the shoulder

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

UF and Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

Location

UF Health Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Methylprednisolone; Methylprednisolone Acetate; Ultrasonography

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: MaryBeth Horodyski, Ed.D., ATC, LAT, FNATA
• Organization: University of Florida

horodmb@ortho.ufl.edu

352-273-7074

Study Officials

• Bradley Schoch, M.D.

  Faculty

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 28, 2017
• Study Start: April 18, 2018
• Primary Completion: June 6, 2019
• Study Completion: June 6, 2019
• Last Updated: June 14, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-06

Locations

US (2)