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Completed

NCT Number: NCT04216017

Glenohumeral Cortisone Injection

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.

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Key information

Conditions

Humeral Fractures Arm Injuries Fractures, Bone Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Washington

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1.18-90

  • Proximal Humerus Fracture
  • Decreased range of motion at 6 wk follow-up
  • 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

Treatment and study plan

kenalog

Drug

Cortisone injection into shoulder

Lidocaine

Drug

Lidocaine injection into shoulder

Primary outcomes

  1. 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 outcomes

  1. Visual Analogue Scale

    Time frame: 24 weeks

    pain scale - high is bad - low is good 0-100

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 2, 2020
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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