Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

Not Applicable

Completed

• Conditions: Bursitis
• Interventions: Drug: Kenalog

• Registration Number: NCT02126878
• Lead Sponsor: West Virginia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-26
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-30
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2020-12-22
• Results First Submitted QC: 2020-12-22
• Results First Posted: 2021-01-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kenalog 80mg	Kenalog	80mg/ 2ml and local anesthetic
Kenalog 20mg	Kenalog	20mg/ 2ml and local anesthetic
Kenalog 40mg	Kenalog	40mg/ 2ml with local anesthetic

Primary Outcome Measures

Name	Time	Method
Pain Intensity Measured on Visual Analog Scale and Percent Improvement	3 month

Secondary Outcome Measures

Name	Time	Method
Disability Measured on Becks Disability Scale	Baseline, 1 month, 3 month
Safety, Adverse Affects	1 month,3 months

Trial Locations

Locations (1)

West Virginia University Hospitals; 🇺🇸 Morgantown, West Virginia, United States