Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
Primary Purpose
Bursitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kenalog
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 approved informed consent form
Exclusion Criteria:
- Meets any contraindication for treatment
- Allergy to triamcinolone, lidocaine
- Previous surgery to bursa
- 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 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Kenalog 20mg
Kenalog 40mg
Kenalog 80mg
Arm Description
20mg/ 2ml and local anesthetic
40mg/ 2ml with local anesthetic
80mg/ 2ml and local anesthetic
Outcomes
Primary Outcome Measures
Pain Intensity Measured on Visual Analog Scale and Percent Improvement
Secondary Outcome Measures
Disability Measured on Becks Disability Scale
Safety, Adverse Affects
Full Information
NCT ID
NCT02126878
First Posted
April 26, 2014
Last Updated
September 23, 2021
Sponsor
West Virginia University
1. Study Identification
Unique Protocol Identification Number
NCT02126878
Brief Title
Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
Official Title
Prospective, Randomized, Double-blinded Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 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
Inflammation of the trochanteric bursa is a common cause of hip pain. A bursa is a closed fluid filled sac or sac-like cavity found between tissues that function as a gliding surface to reduce friction. Bursitis is the inflammation of the bursa. Inflammation between the trochanteric process of the femur and gluteus medius tendon/ iliotibial tract is the cause of trochanteric bursitis. Several treatments exist for trochanteric bursitis, including a local steroid injection. The injection consists of a mixture of local anesthetic and steroid medications. The steroid is routinely mixed with a local anesthetic. The anesthetic acts to diluent the steroid as well as act as a pain reliever. Various steroid preparations have been used, at varying doses, for trochanteric bursitis. The steroid preparation, triamcinolone is commonly used for various reasons. Besides the procedure associated and injection site risks, risks associated with the use of steroids, though rare, exist. Short term, the steroid can raise blood sugar levels and should be used with caution and be appropriately monitored in diabetics. Additionally, the steroid can suppress the immune system. Long-term risks are related to the dose and frequency of use. These risks include thinning of the skin, easy bruising, weight gain, elevated blood pressure, cataract formation, thinning of bones and joints. Studies have shown the effectiveness of local steroid injections for trochanteric bursitis. Unfortunately, there is limited data on the ideal dose of the steroid preparation. Triamcinolone of 40mg/ mL is commonly used, but, studies have shown effectiveness at various doses, ranging 20 to 160 mg/mL. The aim of this study is to evaluate and compare the effectiveness of local steroid injections of various steroid dosages for the treatment of trochanteric bursitis.
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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Kenalog 20mg
Arm Type
Active Comparator
Arm Description
20mg/ 2ml and local anesthetic
Arm Title
Kenalog 40mg
Arm Type
Active Comparator
Arm Description
40mg/ 2ml with local anesthetic
Arm Title
Kenalog 80mg
Arm Type
Active Comparator
Arm Description
80mg/ 2ml and local anesthetic
Intervention Type
Drug
Intervention Name(s)
Kenalog
Primary Outcome Measure Information:
Title
Pain Intensity Measured on Visual Analog Scale and Percent Improvement
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Disability Measured on Becks Disability Scale
Time Frame
Baseline, 1 month, 3 month
Title
Safety, Adverse Affects
Time Frame
1 month,3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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 approved informed consent form
Exclusion Criteria:
Meets any contraindication for treatment
Allergy to triamcinolone, lidocaine
Previous surgery to bursa
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 Steroid Dosages on the Efficacy of Trochanteric Bursa Injection
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