search
Back to results

Glenohumeral Cortisone Injection

Primary Purpose

Humeral Fractures

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
kenalog
Lidocaine
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fractures

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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)
search

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

We'll reach out to this number within 24 hrs