Back Pain, Neck Pain
Conditions
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
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.
Interventions
None listed
Sponsors
University of Manitoba
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Normalization of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Function Following Epidural or Sacroiliac Joint Corticosteroid Injection | From date of enrollment (Baseline) until the date of HPAA normalization assessed every 3 weeks up to 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic 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 | Baseline and 3 weeks | Percent Change in Body Weight |
| Change in Body Weight from Baseline to 6 weeks | Baseline and 6 weeks | Percent Change in Body Weight |
| Change in Body Weight from Baseline to 3 months | Baseline and 3 months | Percent Change in Body Weight |
| Change in Body Weight from Baseline to 6 months | Baseline and 6 months | Percent Change in Body Weight |
| Incidence of Hypothalamic-Pituitary-Adrenal Axis (HPAA) Suppression in Patients Presenting for Corticosteroid Injection | Baseline | 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 | From date of injection until the date of HPAA normalization assessed every 3 weeks up to 6 months | 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 | Baseline and 3 months | Percent glycosylated hemoglobin (HbA1c \[%\]) will be measured by turbidimetric inhibition immunoassay. |
| Change in Glycosylated HbA1c (%) from Baseline to 6 months | Baseline and 6 months | Percent glycosylated hemoglobin (HbA1c \[%\]) will be measured by turbidimetric inhibition immunoassay. |
| Change in Systolic Blood Pressure from Baseline to 3 weeks | Baseline and 3 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Short Form (BPI-SF) Pain Severity and Interference Scores | Baseline and 3, 6, 12, and 24 weeks | 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 | Baseline and 3, 6, 12, and 24 weeks | Completed at Baseline, at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24. |
| Oswestry Disability Index (ODI) v2.0 Scores | Baseline and 3, 6, 12, and 24 weeks | 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) | Baseline and 3, 6, 12, and 24 weeks | Completed at Baseline (for patients with previous corticosteroid injections), at 3 weeks following any corticosteroid injection, and at weeks 6, 12, and 24. |
| Functional Capacity Visual Analogue Scale (FVAS) | Baseline and 3, 6, 12, and 24 weeks | 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. |
| Pain Visual Analogue Scale (PVAS) | Baseline and 3, 6, 12, and 24 weeks | 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. |
Countries
Canada
Contacts
Primary ContactRyan J Amadeo, MD
Outcome results
None listed