Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

Bursitis Clinical Trial

Official title:

Prospective, Randomized, Double-blinded Comparison of Steroid Dosages on the Efficacy of Trochanteric Bursa Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126878
• Other study ID #: 1401174207
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 2015

Study information

• Verified date: September 2021
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis

Intervention

Drug:
• Kenalog

Locations

Country	Name	City	State
United States	West Virginia University Hospitals	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Measured on Visual Analog Scale and Percent Improvement		3 month
Secondary	Disability Measured on Becks Disability Scale		Baseline, 1 month, 3 month
Secondary	Safety, Adverse Affects		1 month,3 months