"Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

December 11, 2017 updated by: Johns Hopkins University

Prospective Randomized-Controlled Two-Arm Study of "Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis

To compare relative efficacy of intraarticular steroid injection using anatomic landmarks vs. fluoroscopy guided technique in decreasing knee osteoarthritis pain 1 month after the procedure.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Adults with knee OA clinically deemed to qualify for steroid injection

Exclusion Criteria:

- Children Non-English Speakers Pregnant

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Blind Steroid Injection
Blind Steroid Injection for patients with OA deemed qualified for it clinically
Other: Blind Steroid Injection
Want to compare it to fluoroscopy guided, with assumption that it will be less effective in reducing pain
Active Comparator: Fluoroscopy guided steroid injection
Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better.
Other: Fluoroscopy guided steroid injection
We want to compare if there is a difference between the two arms, with the assumption that with fluoroscopy will deliver the steroid more accurately and see better outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (pain)
Time Frame: 1 month
Decrease in pain from baseline at one month
1 month

Collaborators and Investigators

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

Sponsor

Johns Hopkins University

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 (Actual)

July 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Actual)

December 12, 2017

Last Update Submitted That Met QC Criteria

December 11, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00026934

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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