Glenohumeral Cortisone Injection

Phase 2

Completed

• Conditions: Humeral Fractures
• Interventions: Drug: Lidocaine; Drug: kenalog

• Registration Number: NCT04216017
• Lead Sponsor: University of Washington

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.

Study Timeline

• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-31
• Study Start: 2020-01-01
• Study First Posted: 2020-01-02
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-01
• Results First Submitted: 2023-02-02
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Results First Posted: 2023-09-26
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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Exclusion Criteria

1. Known drug allergy to kenalog or lidocaine
2. Unable to complete functional outcome
3. Pregnant Women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	Lidocaine	Patients receiving lidocaine
Cases	kenalog	Patients receiving Kenalog

Primary Outcome Measures

Name	Time	Method
American Shoulder Elbow Society Score	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 Outcome Measures

Name	Time	Method
Visual Analogue Scale	24 weeks	pain scale - high is bad - low is good 0-100

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States