The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes.
The main questions it aims to answer are:
Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups?
Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device.
Participants will:
* Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously * Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3 * Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection
Adults aged 20 to 60 years.
Patients scheduled for cervical or lumbar epidural steroid injection at the pain clinic.
Patients capable of understanding and using a Continuous Glucose Monitoring (CGM) device.
Patients currently taking or administering steroid medications.
Patients with Type 1 Diabetes Mellitus.
Patients with Cushing's disease.
Patients who have received an epidural steroid injection within the last 3 months.
Patients visiting the Pain Clinic at Korea University Anam Hospital who are scheduled for cervical or lumbar epidural steroid injections due to spinal pain.
Cohort
Prospective
Epidural Steroid Injection
Procedure/SurgeryAdministration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance.
Continuous Glucose Monitoring
DeviceA sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days.
Change in Daily Mean Glucose
The difference in daily mean glucose levels (mg/dL) measured by CGM between the baseline period (Day 1-2) and the post-injection period (Day 3-15).
Change in Time in Range (TIR)
The difference in the percentage of time (%) spent within the target glucose range (70-180 mg/dL) between the baseline period and the post-injection period.
Change in Numeric Rating Scale (NRS)
The change in pain intensity scores reported by participants. The scale ranges from 0 (no pain) to 10 (worst possible pain).
Frequency of Glucose Spikes
The number of hyperglycemic events defined as glucose levels \>180 mg/dL lasting for at least 30 minutes.
Incidence of Nocturnal Hypoglycemia
The percentage of participants experiencing glucose levels \<70 mg/dL during the nighttime period (22:00 to 06:00).
Glucose Variability (Coefficient of Variation)
The coefficient of variation (%CV) of glucose levels, calculated as the standard deviation divided by the mean glucose, to assess glycemic variability.
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Korea University Anam Hospital
Lead sponsor
The Korean Pain Society
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
