Glenohumeral Cortisone Injection
A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
2 other identifiers
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedResults Posted
Study results publicly available
September 26, 2023
CompletedSeptember 26, 2023
August 1, 2023
2.2 years
December 24, 2019
February 2, 2023
August 31, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
24 weeks
Secondary Outcomes (1)
Visual Analogue Scale
24 weeks
Study Arms (2)
Controls
PLACEBO COMPARATORPatients receiving lidocaine
Cases
ACTIVE COMPARATORPatients receiving Kenalog
Interventions
Eligibility Criteria
You may qualify if:
- \. Proximal Humerus Fracture
- \. Decreased range of motion at 6 wk follow-up
- \. Likely to be available for follow up for 26 wks
You may not qualify if:
- Known drug allergy to kenalog or lidocaine
- Unable to complete functional outcome
- Pregnant Women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jonah Hebert-Davies
- Organization
- University of Washington
Study Officials
- PRINCIPAL INVESTIGATOR
Jonah Hebert-Davies, MD
University of Washington
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, School of Medicine: Orthopedics
Study Record Dates
First Submitted
December 24, 2019
First Posted
January 2, 2020
Study Start
January 1, 2020
Primary Completion
April 1, 2022
Study Completion
May 1, 2022
Last Updated
September 26, 2023
Results First Posted
September 26, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share