Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis
Primary Purpose
Bursitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trochanter bursa injections
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Bursitis
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of trochanteric bursitis
- 18 years of age or older when written informed consent is obtained
- Signed Institutional Review Board (IRB) approved informed consent form
Exclusion Criteria:
- Allergy to triamcinolone or bupivicaine
- Coagulopathy
- Active Infection
- Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Sites / Locations
- West Virginia University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Blind
Ultrasound
Arm Description
Trochanter injection
Trochanter injection
Outcomes
Primary Outcome Measures
Pain Intensity Measured on Visual Analog Scale (VAS)
Secondary Outcome Measures
Disability Measured on Becks Disability Scale
Adverse Effects
Pain Improvement
Percent improvement
Full Information
NCT ID
NCT02221817
First Posted
August 16, 2014
Last Updated
September 23, 2021
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT02221817
Brief Title
Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis
Official Title
Prospective, Randomized Trial of Ultrasound Guided and Blind Corticosteroid Injection for Trochanteric Bursitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West Virginia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Trochanteric bursitis is a common condition, effecting 20% of the population. \Most with trochanteric bursitis experience chronic intermittent or continuous hip pain at and around the greater trochanter.
The cause of trochanteric bursitis is believed to be a result of inflammation of the bursa, though this has not been confirmed. Accordingly, the use of corticosteroid injections has been shown to provide considerable relief. However, routine "blind" injections, those performed without the aid of imaging, such as fluoroscopy, have shown limited success in the appropriate needle placement. Fortunately, blind injections have yielded positive results in majority of the cases. Additionally, the use of fluoroscopy has not shown to improve clinical outcome for trochanter bursa injections.
Although the use of fluoroscopy has not shown positive benefit, other modes of imaging, such as ultrasound have not been studied and may be more useful. Fluoroscopy allows for bony-landmark based injections. Ultrasound allows for direct visualization of the soft tissue structures such as the bursa and has gained significant support for use in musculoskeletal injections. This prospective blinded study's aim is to evaluate, if any, the benefit of an ultrasound guided injection and whether ultrasound should be routinely used during trochanter bursa injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bursitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blind
Arm Type
Active Comparator
Arm Description
Trochanter injection
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Trochanter injection
Intervention Type
Procedure
Intervention Name(s)
Trochanter bursa injections
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Pain Intensity Measured on Visual Analog Scale (VAS)
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Disability Measured on Becks Disability Scale
Time Frame
Baseline, 2 weeks, 3 month
Title
Adverse Effects
Time Frame
2 weeks, 3 month
Title
Pain Improvement
Description
Percent improvement
Time Frame
2 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of trochanteric bursitis
18 years of age or older when written informed consent is obtained
Signed Institutional Review Board (IRB) approved informed consent form
Exclusion Criteria:
Allergy to triamcinolone or bupivicaine
Coagulopathy
Active Infection
Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
Facility Information:
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Ultrasound Guided Versus Blind Corticosteroid Injection for Trochanteric Bursitis
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