Glenohumeral Cortisone Injection
Overview
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.
Full Title of Study: “A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: April 1, 2022
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.
Interventions
- Drug: kenalog
- Cortisone injection into shoulder
- Drug: Lidocaine
- Lidocaine injection into shoulder
Arms, Groups and Cohorts
- Placebo Comparator: Controls
- Patients receiving lidocaine
- Active Comparator: Cases
- Patients receiving Kenalog
Clinical Trial Outcome Measures
Primary Measures
- American Shoulder Elbow Society Score
- Time Frame: 24 weeks
- 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 Measures
- Visual Analogue Scale
- Time Frame: 24 weeks
- pain scale – high is bad – low is good 0-100
Participating in This Clinical Trial
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:
1. Known drug allergy to kenalog or lidocaine 2. Unable to complete functional outcome 3. Pregnant Women
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of Washington
- Collaborator
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Provider of Information About this Clinical Study
- Principal Investigator: Jonah Hebert-Davies, Assistant Professor, School of Medicine: Orthopedics – University of Washington
- Overall Official(s)
- Jonah Hebert-Davies, MD, Principal Investigator, University of Washington
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.