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

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