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Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

NCT ID: NCT02126878

Last Updated: 2021-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Bursitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Kenalog 20mg

20mg/ 2ml and local anesthetic

Group Type ACTIVE_COMPARATOR

Kenalog

Intervention Type DRUG

Kenalog 40mg

40mg/ 2ml with local anesthetic

Group Type ACTIVE_COMPARATOR

Kenalog

Intervention Type DRUG

Kenalog 80mg

80mg/ 2ml and local anesthetic

Group Type ACTIVE_COMPARATOR

Kenalog

Intervention Type DRUG

Interventions

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Kenalog

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West Virginia University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West Virginia University Hospitals

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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1401174207

Identifier Type: -

Identifier Source: org_study_id