Glenohumeral Cortisone Injection

NCT ID: NCT04216017

Last Updated: 2023-09-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Humeral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Controls

Patients receiving lidocaine

Group Type PLACEBO_COMPARATOR

Lidocaine

Intervention Type DRUG

Lidocaine injection into shoulder

Cases

Patients receiving Kenalog

Group Type ACTIVE_COMPARATOR

kenalog

Intervention Type DRUG

Cortisone injection into shoulder

Interventions

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kenalog

Cortisone injection into shoulder

Intervention Type DRUG

Lidocaine

Lidocaine injection into shoulder

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Jonah Hebert-Davies

Assistant Professor, School of Medicine: Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonah Hebert-Davies, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P30AR072572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007576

Identifier Type: -

Identifier Source: org_study_id

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