Clinical trial NCT01717430: Metabolic and Endocrine Effects of Repeated Epidural and Sacroiliac Joint Corticosteroid Injections
Official title: Repeated Epidural and Sacroiliac Joint Glucocorticoid Injections and Their Effect on Hypothalamic-Pituitary-Adrenal Axis Suppression and Metabolic Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Pain
Back Pain
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
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection
timeFrame: From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months
Secondary outcomes:
measure: Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection
timeFrame: Baseline
measure: Incidence of Prolonged (≥ 3 weeks) Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression Following Corticosteroid Injection
timeFrame: From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months
measure: Change in Glycosylated HbA1c (%) from Baseline to 3 months
timeFrame: Baseline and 3 months
measure: Change in Glycosylated HbA1c (%) from Baseline to 6 months
timeFrame: Baseline and 6 months
measure: Change in Systolic Blood Pressure from Baseline to 3 weeks
timeFrame: Baseline and 3 weeks
measure: Change in Systolic Blood Pressure from Baseline to 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Systolic Blood Pressure from Baseline to 3 months
timeFrame: Baseline and 3 months
measure: Change in Systolic Blood Pressure from Baseline to 6 months
timeFrame: Baseline and 6 months
measure: Change in Diastolic Blood Pressure from Baseline to 3 weeks
timeFrame: Baseline and 3 weeks
measure: Change in Diastolic Blood Pressure from Baseline to 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Diastolic Blood Pressure from Baseline to 3 months
timeFrame: Baseline and 3 months
measure: Change in Diastolic Blood Pressure from Baseline to 6 months
timeFrame: Baseline and 6 months
measure: Change in Body Weight from Baseline to 3 weeks
timeFrame: Baseline and 3 weeks
measure: Change in Body Weight from Baseline to 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Body Weight from Baseline to 3 months
timeFrame: Baseline and 3 months
measure: Change in Body Weight from Baseline to 6 months
timeFrame: Baseline and 6 months
Other outcomes:
measure: Pain Visual Analogue Scale (PVAS)
timeFrame: Baseline and 3, 6, 12, and 24 weeks
measure: Functional Capacity Visual Analogue Scale (FVAS)
timeFrame: Baseline and 3, 6, 12, and 24 weeks
measure: Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores
timeFrame: Baseline and 3, 6, 12, and 24 weeks
measure: Medical Outcome Study Short Form 36 (SF-36) Health Survey Scores
timeFrame: Baseline and 3, 6, 12, and 24 weeks
measure: Oswestry Disability Index (ODI) v2.0 Scores
timeFrame: Baseline and 3, 6, 12, and 24 weeks
measure: North American Spine Society Patient Satisfaction Index (PSI)
timeFrame: Baseline and 3, 6, 12, and 24 weeks
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Ryan J Amadeo, MD
role: PRINCIPAL_INVESTIGATOR
References: