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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
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bursitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Clinical diagnosis of trochanteric bursitis
  2. 18 years of age or older when written informed consent is obtained
  3. Signed institutional review board approved informed consent form

Exclusion Criteria:

  1. Meets any contraindication for treatment
  2. Allergy to triamcinolone, lidocaine
  3. Previous surgery to bursa
  4. Coagulopathy
  5. Active Infection
  6. 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

First Posted
April 26, 2014
Last Updated
September 23, 2021
Sponsor
West Virginia University
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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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