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
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:
- 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.
;
Observational Model: Cohort, Time Perspective: Prospective
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