Repeated Epidural and Sacroiliac Joint Glucocorticoid Injections and Their Effect on Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Status
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
研究概览
简要总结
Corticosteroid injections into the epidural space or sacroiliac joint are increasingly used for the treatment of chronic neck, low back, and leg pain. These injections may have several side effects, including suppression of the body's adrenal glands to produce steroids (adrenal suppression) and negative effects on metabolism (weight gain, increased blood pressure, and high blood sugar levels).
The purpose of this study is to determine the time course and predictors of adrenal suppression and the metabolic effects of corticosteroid injections for chronic pain.
The investigators hypothesize normalization of adrenal function to occur within three weeks of injection in most individuals. An increased frequency of injections is predicted to lead to prolonged adrenal suppression. Corticosteroid injections are also hypothesized to lead to increases in body weight, blood pressure, and blood sugar levels, particularly in diabetic individuals.
详细描述
Interventional pain procedures using corticosteroid injections (CIs), such as epidural steroid injections (ESIs) and sacroiliac joint injections (SIJIs), may have adverse metabolic and endocrine effects, including suppression of the hypothalamic-pituitary-adrenal axis (HPAA), hypertension, weight gain, and hyperglycemia. Based on sparse data on these adverse effects following repeated, long-term CIs, current guidelines suggest a maximum frequency of four to six injections annually, even though patients may benefit from more frequent treatments.
This prospective cohort study will follow first-time or repeat ESI or SIJI patients receiving injections with 0.5 mL bupivacaine 0.25% and 15 mg dexamethasone sodium phosphate at a maximum frequency of once every six weeks in order to:
- determine the frequency and duration of HPAA suppression;
- determine the incidence and predictors of prolonged (≥ 3 weeks) HPAA suppression;
- determine the baseline incidence and predictors of HPAA suppression in chronic pain patients presenting for their first CI; and
- determine the effect of CIs on body weight, resting blood pressure, and glycemic control over a six-month period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients receiving SI joint or epidural corticosteroid injections
- •At least 18 years of age
排除标准
- •Contraindication to corticosteroid injection (infection; pregnancy; uncontrolled diabetes mellitus [per patient's report]; active congestive heart failure; coagulopathy; medical conditions that prohibit holding anticoagulant or antiplatelet therapy, with the exception of aspirin, for at least two weeks prior to injection; and allergy to iodinated contrast dye, corticosteroids, or amide local anesthetics)
- •Known disorder of the hypothalamic-pituitary-adrenal axis
- •Corticosteroid injection within 6 weeks of study enrollment
结局指标
主要结局
Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
时间窗: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
The high-dose rapid adrenocorticotropic hormone (ACTH) stimulation test will be performed to determine if HPAA suppression is present. Serum cortisol will be measured by electrochemiluminescence immunoassay immediately prior to and at 30 and 60 min following injection of 250 mcg cosyntropin IV. A serum cortisol level \<550 nmol/L (\<20 mcg/dL) at either time point following cosyntropin administration will designate HPAA suppression.
次要结局
- Change in Diastolic Blood Pressure from Baseline to 6 weeks(Baseline and 6 weeks)
- Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection(From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months)
- Change in Diastolic Blood Pressure from Baseline to 3 months(Baseline and 3 months)
- Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection(Baseline)
- Change in Glycosylated HbA1c (%) from Baseline to 3 months(Baseline and 3 months)
- Change in Systolic Blood Pressure from Baseline to 3 weeks(Baseline and 3 weeks)
- Change in Systolic Blood Pressure from Baseline to 6 weeks(Baseline and 6 weeks)
- Change in Glycosylated HbA1c (%) from Baseline to 6 months(Baseline and 6 months)
- Change in Diastolic Blood Pressure from Baseline to 6 months(Baseline and 6 months)
- Change in Systolic Blood Pressure from Baseline to 3 months(Baseline and 3 months)
- Change in Systolic Blood Pressure from Baseline to 6 months(Baseline and 6 months)
- Change in Diastolic Blood Pressure from Baseline to 3 weeks(Baseline and 3 weeks)
- Change in Body Weight from Baseline to 3 weeks(Baseline and 3 weeks)
- Change in Body Weight from Baseline to 6 weeks(Baseline and 6 weeks)
- Change in Body Weight from Baseline to 3 months(Baseline and 3 months)
- Change in Body Weight from Baseline to 6 months(Baseline and 6 months)
研究者
Dr. Ryan Amadeo
Assistant Professor
University of Manitoba