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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan J Amadeo, MD | Contact | 204-787-1414 | ramadeo@shaw.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ryan J Amadeo, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Recruiting | Winnipeg | Manitoba | R3Y 1X1 | Canada |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| D017116 | Low Back Pain |
| D012585 | Sciatica |
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
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 |
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |