Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections

This study is currently recruiting participants.
Verified October 2012 by University of Manitoba
Sponsor:
Information provided by (Responsible Party):
Dr. Ryan Amadeo, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01717430
First received: October 8, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition
Neck Pain
Back Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Consequences in Patients Receiving Repeated Epidural and Sacroiliac Joint Corticosteroid Injections

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection [ Time Frame: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection [ Time Frame: From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months ] [ Designated as safety issue: No ]
    The high-dose rapid ACTH stimulation test will be performed to determine if HPAA suppression is present.

  • Change in Glycosylated HbA1c (%) from Baseline to 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.

  • Change in Glycosylated HbA1c (%) from Baseline to 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.

  • Change in Systolic Blood Pressure from Baseline to 3 weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure from Baseline to 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure from Baseline to 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in Systolic Blood Pressure from Baseline to 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure from Baseline to 3 weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure from Baseline to 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure from Baseline to 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure from Baseline to 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Body Weight from Baseline to 3 weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    Percent Change in Body Weight

  • Change in Body Weight from Baseline to 6 weeks [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    Percent Change in Body Weight

  • Change in Body Weight from Baseline to 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]
    Percent Change in Body Weight

  • Change in Body Weight from Baseline to 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    Percent Change in Body Weight


Other Outcome Measures:
  • Pain Visual Analogue Scale (PVAS) [ Time Frame: Baseline and 3, 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Functional Capacity Visual Analogue Scale (FVAS) [ Time Frame: Baseline and 3, 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
    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.

  • Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores [ Time Frame: Baseline and 3, 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
    Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.

  • Medical Outcome Study Short Form 36 (SF-36) Health Survey Scores [ Time Frame: Baseline and 3, 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
    Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.

  • Oswestry Disability Index (ODI) v2.0 Scores [ Time Frame: Baseline and 3, 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
    Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.

  • North American Spine Society Patient Satisfaction Index (PSI) [ Time Frame: Baseline and 3, 6, 12, and 24 weeks ] [ Designated as safety issue: No ]
    Completed at Baseline (for patients with previous corticosteroid injections), at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24.


Estimated Enrollment: 126
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717430

Contacts
Contact: Ryan J Amadeo, MD 204-787-1414 ramadeo@shaw.ca

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3Y 1X1
Contact: Maria Loureiro    204-787-2404    healthtrials@hsc.mb.ca   
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Ryan J Amadeo, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Ryan Amadeo, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT01717430     History of Changes
Other Study ID Numbers: B2012:062
Study First Received: October 8, 2012
Last Updated: October 25, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
Injections, epidural
Injections, intra-articular
Chronic pain
Neck pain
Back pain
Low back pain
Sciatica
Sacroiliac joint
Corticosteroids
Dexamethasone
Adrenocorticotropic hormone
Adrenal insufficiency
Hemoglobin A, glycosylated

Additional relevant MeSH terms:
Back Pain
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Adrenocorticotropic Hormone
Dexamethasone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 15, 2014