Back to resultsPredicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Primary Purpose
Osteoarthritis of the Glenohumeral Joint
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
intraarticular corticosteroid injections (IACSI)
corticosteroid injections
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of the Glenohumeral Joint
Eligibility Criteria
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
Sites / Locations
- UF and Shands Orthopaedics and Sports Medicine Institute
- UF Health Orthopaedics and Sports Medicine Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
symptomatic primary osteoarthritis of the shoulder
Arm Description
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
Outcomes
Primary Outcome Measures
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).
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.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03232749
Brief Title
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Official Title
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
The physician in charge is leaving the University of Florida
Study Start Date
April 18, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Glenohumeral Joint
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
symptomatic primary osteoarthritis of the shoulder
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
intraarticular corticosteroid injections (IACSI)
Intervention Description
ultrasound-guided IACSI will be administered
Intervention Type
Drug
Intervention Name(s)
corticosteroid injections
Other Intervention Name(s)
Methylprednisolone, Depo-medrol
Intervention Description
Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
ultrasound-guided IACSI
Primary Outcome Measure Information:
Title
ASES Scores at Each Time Point
Description
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
Title
Visual Analog Scale Scores at Each Time Point.
Description
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
Title
SST (Simple Shoulder Test) Scores at Each Time Point
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley Schoch, M.D.
Organizational Affiliation
Faculty
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF and Shands Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
UF Health Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Predicting Response to Intra-Articular Corticosteroid Injection in Patients With Osteoarthritis of the Glenohumeral Joint
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