Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

August 3, 2018 updated by: Miguel Ramirez, OSF Healthcare System
The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • knee and shoulder arthritis
  • shoulder impingement
  • rotator cuff tear

Exclusion Criteria:

  • chronic pain management
  • allergy to NSAIDs or steroids
  • prior surgery
  • kidney disease that would preclude NSAID administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketorolac
Drug: Shoulder injection
intra articular or subacromial shoulder injection
Drug: knee injection
intra-articular knee injection
EXPERIMENTAL: Kenalog
Drug: Shoulder injection
intra articular or subacromial shoulder injection
Drug: knee injection
intra-articular knee injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level: VAS score
Time Frame: 0-6 months
VAS score
0-6 months
length pain relief
Time Frame: 0-6 months
length of time patient reports pain relief
0-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSF Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2018

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (ACTUAL)

August 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1209087-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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