Glenohumeral Cortisone Injection

Humeral Fractures Clinical Trial

Official title:

A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04216017
• Other study ID #: STUDY00007576
• Secondary ID: P30AR072572
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: May 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Humeral Fractures

Intervention

Drug:
• kenalog
Cortisone injection into shoulder
• Lidocaine
Lidocaine injection into shoulder

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analogue Scale	pain scale - high is bad - low is good 0-100	24 weeks