Glenohumeral Cortisone Injection

Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT04216017
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
12
1
2
28
0.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel 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
Actual Study Start Date :
Jan 1, 2020
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. American Shoulder Elbow Society Score [24 weeks]

    Outcome Instrument high is good low is bad 0-100

Secondary Outcome Measures

  1. Visual Analogue Scale [24 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

1.18-90

  1. Proximal Humerus Fracture

  2. Decreased range of motion at 6 wk follow-up

  3. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Washington Seattle Washington United States 98104

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jonah Hebert-Davies, MD, University of Washington

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonah Hebert-Davies, Assistant Professor, School of Medicine: Orthopedics, University of Washington
ClinicalTrials.gov Identifier:
NCT04216017
Other Study ID Numbers:
  • STUDY00007576
  • P30AR072572
First Posted:
Jan 2, 2020
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022