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.
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.
Study Type
OBSERVATIONAL
Enrollment
126
Health Sciences Centre
Winnipeg, Manitoba, Canada
RECRUITINGTime to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
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.
Time frame: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
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.
Time frame: Baseline
Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
The high-dose rapid ACTH stimulation test will be performed to determine if HPAA suppression is present.
Time frame: From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
Change in Glycosylated HbA1c (%) from Baseline to 3 months
Percent glycosylated hemoglobin (HbA1c \[%\]) will be measured by turbidimetric inhibition immunoassay.
Time frame: Baseline and 3 months
Change in Glycosylated HbA1c (%) from Baseline to 6 months
Percent glycosylated hemoglobin (HbA1c \[%\]) will be measured by turbidimetric inhibition immunoassay.
Time frame: Baseline and 6 months
Change in Systolic Blood Pressure from Baseline to 3 weeks
Time frame: Baseline and 3 weeks
Change in Systolic Blood Pressure from Baseline to 6 weeks
Time frame: Baseline and 6 weeks
Change in Systolic Blood Pressure from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Systolic Blood Pressure from Baseline to 6 months
Time frame: Baseline and 6 months
Change in Diastolic Blood Pressure from Baseline to 3 weeks
Time frame: Baseline and 3 weeks
Change in Diastolic Blood Pressure from Baseline to 6 weeks
Time frame: Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months
Time frame: Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks
Percent Change in Body Weight
Time frame: Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks
Percent Change in Body Weight
Time frame: Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months
Percent Change in Body Weight
Time frame: Baseline and 3 months
Change in Body Weight from Baseline to 6 months
Percent Change in Body Weight
Time frame: Baseline and 6 months
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