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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04216017
Other study ID # STUDY00007576
Secondary ID P30AR072572
Status Completed
Phase Phase 2
First received
Last updated
Start date January 1, 2020
Est. completion date May 1, 2022

Study information

Verified date August 2023
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date May 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
kenalog
Cortisone injection into shoulder
Lidocaine
Lidocaine injection into shoulder

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks
Secondary Visual Analogue Scale pain scale - high is bad - low is good 0-100 24 weeks
See also
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