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临床试验/NCT01799408
NCT01799408已完成不适用

The Effect of Intra-articular Injection of Betamethasone Acetate/Betamethasone Sodium Phosphate at the Knee Joint on the Hypothalamic-pituitary-adrenal Axis: a Case Controlled Study

The Nazareth Hospital, Israel0 个研究点目标入组 40 人开始时间: 2012年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
主要终点
Adrenal Suppression

研究概览

简要总结

To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients with osteoarthritis of the knee

详细描述

Consecutive patients attending the rheumatology or orthopedic clinic with osteoarthritic knee pain, not responding satisfactorily to medical or physical therapy were allocated to group-1 after consent and given IACI of 6 mg of betamethasone acetate/betamethasone sodium phosphate. Following completion of this part, consecutive age- and sex-matched patients were allocated to group-2 and given intra-articular injection of 60 mg of sodium hyaluronate. Just prior to the knee injection and 1, 2, 3, 4 and 8 weeks later, patients had 1 µg adrenocorticotropin hormone (ACTH) stimulation test. Secondary adrenal insufficiency (SAI) was defined as levels of less than 18 ng/ml or a rise of < than 7 ng/ml of serum cortisol, 30 minutes following the ACTH stimulation test.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Osteoarthritis of the knee

排除标准

  • Had steroids in the last 3 months. Allergic to steroids

结局指标

主要结局

Adrenal Suppression

时间窗: 2 months

Adrenal gland suupresion and inability to adequately secrete cortisol in response to stress

次要结局

  • favorable clinical response(2 months)
  • Favorable clinical response(2 months following the steroid injection)

研究者

发起方
The Nazareth Hospital, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

George Habib

Head rheunatology clinic

The Nazareth Hospital, Israel

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