Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections
2014年12月10日 更新者：Dr. Ryan Amadeo、University of Manitoba
Repeated Epidural and Sacroiliac Joint Glucocorticoid Injections and Their Effect on Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Status
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
126
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R3Y 1X1
- 招聘中
- Health Sciences Centre
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接触：
- Maria Loureiro
- 电话号码：204-787-2404
- 邮箱：healthtrials@hsc.mb.ca
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients receiving initial or repeated sacroiliac (SI) joint injections or single- or multi-level epidural injections with corticosteroids as part of their management plan for chronic SI joint, neck, back, or radicular pain.
描述
Inclusion Criteria:
- Patients receiving SI joint or epidural corticosteroid injections
- At least 18 years of age
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Corticosteroid injection
Consecutive patients receiving initial or repeated sacroiliac joint or single or multi-level epidural corticosteroid injections as part of their management plan for SI joint, neck, back, or radicular pain.
Injections will be performed using 0.5 mL bupivacaine 0.25% and 15 mg dexamethasone sodium phosphate.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
大体时间：From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
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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.
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From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
大体时间：Baseline
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The high-dose rapid ACTH stimulation test will be performed at Baseline to determine if HPAA suppression is present in patients presenting for corticosteroid injection.
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Baseline
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Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
大体时间：From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
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The high-dose rapid ACTH stimulation test will be performed to determine if HPAA suppression is present.
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From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
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Change in Glycosylated HbA1c (%) from Baseline to 3 months
大体时间：Baseline and 3 months
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Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
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Baseline and 3 months
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Change in Glycosylated HbA1c (%) from Baseline to 6 months
大体时间：Baseline and 6 months
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Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.
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Baseline and 6 months
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Change in Systolic Blood Pressure from Baseline to 3 weeks
大体时间：Baseline and 3 weeks
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Baseline and 3 weeks
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Change in Systolic Blood Pressure from Baseline to 6 weeks
大体时间：Baseline and 6 weeks
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Baseline and 6 weeks
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Change in Systolic Blood Pressure from Baseline to 3 months
大体时间：Baseline and 3 months
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Baseline and 3 months
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Change in Systolic Blood Pressure from Baseline to 6 months
大体时间：Baseline and 6 months
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Baseline and 6 months
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Change in Diastolic Blood Pressure from Baseline to 3 weeks
大体时间：Baseline and 3 weeks
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Baseline and 3 weeks
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Change in Diastolic Blood Pressure from Baseline to 6 weeks
大体时间：Baseline and 6 weeks
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Baseline and 6 weeks
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Change in Diastolic Blood Pressure from Baseline to 3 months
大体时间：Baseline and 3 months
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Baseline and 3 months
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Change in Diastolic Blood Pressure from Baseline to 6 months
大体时间：Baseline and 6 months
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Baseline and 6 months
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Change in Body Weight from Baseline to 3 weeks
大体时间：Baseline and 3 weeks
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Percent Change in Body Weight
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Baseline and 3 weeks
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Change in Body Weight from Baseline to 6 weeks
大体时间：Baseline and 6 weeks
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Percent Change in Body Weight
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Baseline and 6 weeks
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Change in Body Weight from Baseline to 3 months
大体时间：Baseline and 3 months
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Percent Change in Body Weight
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Baseline and 3 months
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Change in Body Weight from Baseline to 6 months
大体时间：Baseline and 6 months
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Percent Change in Body Weight
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Baseline and 6 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Pain Visual Analogue Scale (PVAS)
大体时间：Baseline and 3, 6, 12, and 24 weeks
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11-point scale for average pain intensity over the preceding week.
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Functional Capacity Visual Analogue Scale (FVAS)
大体时间：Baseline and 3, 6, 12, and 24 weeks
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11-point scale for average functional impairment over the preceding week.
Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores
大体时间：Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Medical Outcome Study Short Form 36 (SF-36) Health Survey Scores
大体时间：Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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Oswestry Disability Index (ODI) v2.0 Scores
大体时间：Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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North American Spine Society Patient Satisfaction Index (PSI)
大体时间：Baseline and 3, 6, 12, and 24 weeks
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Completed at Baseline (for patients with previous corticosteroid injections), at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.
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Baseline and 3, 6, 12, and 24 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ryan J Amadeo, MD、University of Manitoba
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年10月1日
初级完成 (预期的)
2016年6月1日
研究完成 (预期的)
2016年12月1日
研究注册日期
首次提交
2012年10月8日
首先提交符合 QC 标准的
2012年10月25日
首次发布 (估计)
2012年10月30日
研究记录更新
最后更新发布 (估计)
2014年12月12日
上次提交的符合 QC 标准的更新
2014年12月10日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.