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Glenohumeral Cortisone Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216017
Recruitment Status : Not yet recruiting
First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Jonah Hebert-Davies, 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.

Condition or disease Intervention/treatment Phase
Humeral Fractures Drug: kenalog Drug: Lidocaine Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Pilot Study Evaluating the Efficacy of Early Glenohumeral Cortisone Injection in Patients With Shoulder Stiffness Following Proximal Humerus Fractures
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Controls
Patients receiving lidocaine
Drug: Lidocaine
Lidocaine injection into shoulder

Active Comparator: Cases
Patients receiving Kenalog
Drug: kenalog
Cortisone injection into shoulder




Primary Outcome Measures :
  1. American Shoulder Elbow Society Score [ Time Frame: 24 weeks ]
    Outcome Instrument high is good low is bad 0-100


Secondary Outcome Measures :
  1. Visual Analogue Scale [ Time Frame: 24 weeks ]
    pain scale - high is bad - low is good 0-100



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216017


Contacts
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Contact: Julie Agel 206.744.4113 bagel@uw.edu

Sponsors and Collaborators
University of Washington
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Jonah Hebert-Davies, MD University of Washington
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Responsible Party: Jonah Hebert-Davies, Assistant Professor, School of Medicine: Orthopedics, University of Washington
ClinicalTrials.gov Identifier: NCT04216017    
Other Study ID Numbers: STUDY00007576
First Posted: January 2, 2020    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Humeral Fractures
Fractures, Bone
Wounds and Injuries
Arm Injuries
Triamcinolone Acetonide
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors