- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02104726
"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Withdrawn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
|
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.
|
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
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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