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

Neck Pain Clinical Trial

Official title:

Repeated Epidural and Sacroiliac Joint Glucocorticoid Injections and Their Effect on Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Status

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01717430
• Other study ID #: B2012:062
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2012
• Last updated: December 10, 2014
• Start date: October 2012
• Est. completion date: December 2016

Study information

• Verified date: December 2014
• Source: University of Manitoba
• Contact: Ryan J Amadeo, MD
• Phone: 204-787-1414
• Email: ramadeo[@]shaw.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Locations

Country	Name	City	State
Canada	Health Sciences Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Glycosylated HbA1c (%) from Baseline to 3 months	Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.	Baseline and 3 months	No
Secondary	Change in Glycosylated HbA1c (%) from Baseline to 6 months	Percent glycosylated hemoglobin (HbA1c [%]) will be measured by turbidimetric inhibition immunoassay.	Baseline and 6 months	No
Secondary	Change in Systolic Blood Pressure from Baseline to 3 weeks		Baseline and 3 weeks	No
Secondary	Change in Systolic Blood Pressure from Baseline to 6 weeks		Baseline and 6 weeks	No
Secondary	Change in Systolic Blood Pressure from Baseline to 3 months		Baseline and 3 months	No
Secondary	Change in Systolic Blood Pressure from Baseline to 6 months		Baseline and 6 months	No
Secondary	Change in Diastolic Blood Pressure from Baseline to 3 weeks		Baseline and 3 weeks	No
Secondary	Change in Diastolic Blood Pressure from Baseline to 6 weeks		Baseline and 6 weeks	No
Secondary	Change in Diastolic Blood Pressure from Baseline to 3 months		Baseline and 3 months	No
Secondary	Change in Diastolic Blood Pressure from Baseline to 6 months		Baseline and 6 months	No
Secondary	Change in Body Weight from Baseline to 3 weeks	Percent Change in Body Weight	Baseline and 3 weeks	No
Secondary	Change in Body Weight from Baseline to 6 weeks	Percent Change in Body Weight	Baseline and 6 weeks	No
Secondary	Change in Body Weight from Baseline to 3 months	Percent Change in Body Weight	Baseline and 3 months	No
Secondary	Change in Body Weight from Baseline to 6 months	Percent Change in Body Weight	Baseline and 6 months	No