NCT03232749

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

Terminated Phase 4 Results posted Last updated 14 June 2021

What this trial tests

Phase 4 trial testing intraarticular corticosteroid injections (IACSI) in Osteoarthritis of the Glenohumeral Joint in 25 participants. Terminated before completion.

Timeline

18 April 2018

Primary endpoint
6 June 2019

6 June 2019

Quick facts

Lead sponsor	University of Florida
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	18 April 2018
Primary completion	6 June 2019
Estimated completion	6 June 2019
Sites	2 locations across United States

Drugs / interventions tested

• intraarticular corticosteroid injections (IACSI)
• corticosteroid injections — full drug profile →
• Ultrasound

Conditions studied

• Osteoarthritis of the Glenohumeral Joint — all drugs for Osteoarthritis of the Glenohumeral Joint →

Sponsor

University of Florida

Who can join

Adults 18 to 100, any sex, with Osteoarthritis of the Glenohumeral Joint. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

ASES Scores at Each Time Point Primary · 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).

Baseline ASES score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	48.52	± 13.18

2 Week ASES score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	79.72	± 23.32

1 Month ASES scrore

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	73.86	± 28.24

2 Month ASES score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	28.60	± 28.57

3 Month ASES score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	71.78	± 22.34

6 Month ASES score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	61.48	± 25.78

Visual Analog Scale Scores at Each Time Point. Primary · 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.

Baseline VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	4.54	± 2.62

Post-injection VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	1.86	± 1.80

2 Weeks VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	1.18	± 1.59

1 Month VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	2.05	± 2.06

2 Month VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	2.56	± 2.97

3 Month VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	2.50	± 2.38

6 Month VAS score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	2.44	± 3.05

SST (Simple Shoulder Test) Scores at Each Time Point Primary · 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)

Baseline SST Score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	5.29	± 2.46

2 Week SST Score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	8.40	± 2.36

1 Month SST Score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	7.32	± 3.82

2 Month SST Score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	5.92	± 3.43

3 Month SST Score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	6.73	± 3.32

6 Month SST Score

Group	Value	95% CI
Symptomatic Primary Osteoarthritis of the Shoulder	7.00	± 2.73

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.