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临床试验/NCT02126878
NCT02126878已完成不适用

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

West Virginia University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Pain Intensity Measured on Visual Analog Scale and Percent Improvement

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Kenalog 20mg

Active Comparator

20mg/ 2ml and local anesthetic

干预措施: Kenalog (Drug)

Kenalog 40mg

Active Comparator

40mg/ 2ml with local anesthetic

干预措施: Kenalog (Drug)

Kenalog 80mg

Active Comparator

80mg/ 2ml and local anesthetic

干预措施: Kenalog (Drug)

结局指标

主要结局

Pain Intensity Measured on Visual Analog Scale and Percent Improvement

时间窗: 3 month

次要结局

  • Disability Measured on Becks Disability Scale(Baseline, 1 month, 3 month)
  • Safety, Adverse Affects(1 month,3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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