Recruiting

Corticosteroid Injections

Sponsor:

University of Manitoba

Code:

NCT01717430

Conditions

Neck Pain

Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Neck Pain

Back Pain

Study ID

NCT01717430

Start date

Oct, 2012

Status verified date

Dec, 2014

Completion date

Dec, 2016

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

126 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ryan J Amadeo, MD

204-787-1414ramadeo@shaw.ca

Locations

Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3Y 1X1

Contacts

Maria Loureiro

204-787-2404healthtrials@hsc.mb.ca

More Information

Sponsor

University of Manitoba

Last update posted

Dec 12, 2014

Last verified

Dec, 2014

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2014-12-12.