Clinical trial NCT02126878: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bursitis
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Intensity Measured on Visual Analog Scale and Percent Improvement
timeFrame: 3 month
Secondary outcomes:
measure: Disability Measured on Becks Disability Scale
timeFrame: Baseline, 1 month, 3 month
measure: Safety, Adverse Affects
timeFrame: 1 month,3 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University Hospitals
state: West Virginia
Study officials:
References: