Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections

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.

Study Overview

• Status: Unknown
• Conditions: Back Pain; Neck Pain

Detailed Description

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 (Anticipated): 126

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3Y 1X1
      • Recruiting
      • Health Sciences Centre
      • Contact: Maria Loureiro; Phone Number: 204-787-2404; Email: healthtrials@hsc.mb.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time 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.	From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and 3 months
Change in Glycosylated HbA1c (%) from Baseline to 6 months	Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.	Baseline and 6 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 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 Diastolic Blood Pressure from Baseline to 6 weeks		Baseline and 6 weeks
Change in Diastolic Blood Pressure from Baseline to 3 months		Baseline and 3 months
Change in Diastolic Blood Pressure from Baseline to 6 months		Baseline and 6 months
Change in Body Weight from Baseline to 3 weeks	Percent Change in Body Weight	Baseline and 3 weeks
Change in Body Weight from Baseline to 6 weeks	Percent Change in Body Weight	Baseline and 6 weeks
Change in Body Weight from Baseline to 3 months	Percent Change in Body Weight	Baseline and 3 months
Change in Body Weight from Baseline to 6 months	Percent Change in Body Weight	Baseline and 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Visual Analogue Scale (PVAS)	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.	Baseline and 3, 6, 12, and 24 weeks
Functional Capacity Visual Analogue Scale (FVAS)	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.	Baseline and 3, 6, 12, and 24 weeks
Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores	Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.	Baseline and 3, 6, 12, and 24 weeks
Medical Outcome Study Short Form 36 (SF-36) Health Survey Scores	Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.	Baseline and 3, 6, 12, and 24 weeks
Oswestry Disability Index (ODI) v2.0 Scores	Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.	Baseline and 3, 6, 12, and 24 weeks
North American Spine Society Patient Satisfaction Index (PSI)	Completed at Baseline (for patients with previous corticosteroid injections), at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.	Baseline and 3, 6, 12, and 24 weeks

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Ryan J Amadeo, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: October 8, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 30, 2012

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 10, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Sciatica; Low back pain; Back pain; Chronic pain; Dexamethasone; Neck pain; Corticosteroids; Adrenocorticotropic hormone; Sacroiliac joint; Adrenal insufficiency; Injections, intra-articular; Injections, epidural; Hemoglobin A, glycosylated
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Neck Pain
• Other Study ID Numbers: B2012:062