Glenohumeral Cortisone Injection
Primary Purpose
Humeral Fractures
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
kenalog
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Humeral Fractures
Eligibility Criteria
Inclusion Criteria:
1.18-90
2. Proximal Humerus Fracture
3. Decreased range of motion at 6 wk follow-up
4. Likely to be available for follow up for 26 wks
Exclusion Criteria:
- Known drug allergy to kenalog or lidocaine
- Unable to complete functional outcome
- Pregnant Women
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Controls
Cases
Arm Description
Patients receiving lidocaine
Patients receiving Kenalog
Outcomes
Primary Outcome Measures
American Shoulder Elbow Society Score
Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Secondary Outcome Measures
Visual Analogue Scale
pain scale - high is bad - low is good 0-100
Full Information
NCT ID
NCT04216017
First Posted
December 24, 2019
Last Updated
August 31, 2023
Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT04216017
Brief Title
Glenohumeral Cortisone Injection
Official Title
A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this project is to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
Detailed Description
THis is a randomized control trial to determine if giving a cortisone injection to patients with proximal humerus fractures who have stiff shoulders recover their range of motion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls
Arm Type
Placebo Comparator
Arm Description
Patients receiving lidocaine
Arm Title
Cases
Arm Type
Active Comparator
Arm Description
Patients receiving Kenalog
Intervention Type
Drug
Intervention Name(s)
kenalog
Intervention Description
Cortisone injection into shoulder
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine injection into shoulder
Primary Outcome Measure Information:
Title
American Shoulder Elbow Society Score
Description
Outcome Instrument high is good low is bad 0-100 The ASES is a condition-specific scale that is intended to measure functional limitations and pain of the shoulder.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale
Description
pain scale - high is bad - low is good 0-100
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.18-90
2. Proximal Humerus Fracture
3. Decreased range of motion at 6 wk follow-up
4. Likely to be available for follow up for 26 wks
Exclusion Criteria:
Known drug allergy to kenalog or lidocaine
Unable to complete functional outcome
Pregnant Women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonah Hebert-Davies, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Glenohumeral Cortisone Injection
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