"Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluoroscopy guided steroid injection
Blind Steroid Injection
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Adults with knee OA clinically deemed to qualify for steroid injection
Exclusion Criteria:
- Children Non-English Speakers Pregnant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Blind Steroid Injection
Fluoroscopy guided steroid injection
Arm Description
Blind Steroid Injection for patients with OA deemed qualified for it clinically
Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better.
Outcomes
Primary Outcome Measures
Numerical Rating Scale (pain)
Decrease in pain from baseline at one month
Secondary Outcome Measures
Full Information
NCT ID
NCT02104726
First Posted
April 2, 2014
Last Updated
December 11, 2017
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT02104726
Brief Title
"Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis
Official Title
Prospective Randomized-Controlled Two-Arm Study of "Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Withdrawn
Study Start Date
July 2014 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blind Steroid Injection
Arm Type
Active Comparator
Arm Description
Blind Steroid Injection for patients with OA deemed qualified for it clinically
Arm Title
Fluoroscopy guided steroid injection
Arm Type
Active Comparator
Arm Description
Fluoroscopy guided Steroid Injection for patients with OA deemed qualified for it clinically. We want to see which one is better.
Intervention Type
Other
Intervention Name(s)
Fluoroscopy guided steroid injection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blind Steroid Injection
Intervention Description
Want to compare it to fluoroscopy guided, with assumption that it will be less effective in reducing pain
Primary Outcome Measure Information:
Title
Numerical Rating Scale (pain)
Description
Decrease in pain from baseline at one month
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Adults with knee OA clinically deemed to qualify for steroid injection
Exclusion Criteria:
- Children Non-English Speakers Pregnant
12. IPD Sharing Statement
Learn more about this trial
"Blind" vs. Fluoroscopy-Guided Steroid Injections for Knee Osteoarthritis
We'll reach out to this number within 24 hrs