Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Korean Pain Society | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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:
Epidural steroid injections (ESIs) are a widely used non-surgical treatment for radicular pain caused by spinal conditions such as herniated discs and spinal stenosis. While effective for pain relief, the systemic absorption of corticosteroids (e.g., dexamethasone) can induce temporary hyperglycemia, which poses potential risks, particularly for patients with type 2 diabetes mellitus (T2DM).
Previous studies on post-ESI hyperglycemia have largely relied on self-monitoring of blood glucose (SMBG), which captures only intermittent glucose data and may miss significant glycemic excursions, such as postprandial spikes or nocturnal hypoglycemia. This study aims to overcome these limitations by using a Continuous Glucose Monitoring (CGM) system to provide a comprehensive, time-series analysis of glycemic fluctuations.
Objectives:
To compare glycemic changes (mean glucose, Time in Range [TIR], Time Above Range [TAR]) following an epidural steroid injection with 5 mg of dexamethasone between a type 2 diabetes group and a non-diabetes control group.
To investigate the correlation between baseline HbA1c levels and the magnitude of post-injection glycemic variability.
Study Design: This is a prospective, observational, comparative study conducted at a single center (Korea University Anam Hospital). A total of 36 participants (18 in the T2DM group and 18 in the Non-DM group) will be enrolled.
Study Procedures:
Visit 1 (Day 1 - Screening & Baseline):
Visit 2 (Day 3 - Intervention):
Visit 3 (Day 15 - Follow-up & Data Collection):
Statistical Analysis: The primary endpoints (changes in mean daily glucose and TIR) will be analyzed using a Linear Mixed Model (LMM) to account for repeated measures. Fixed effects will include Group (DM vs. Non-DM), Time (Baseline vs. Post-injection), and the Group-by-Time interaction. Patient demographics (e.g., age, BMI) will be included as covariates if significant differences are observed at baseline. A p-value of <0.05 will be considered statistically significant.
This study will provide high-resolution data on the duration and severity of steroid-induced hyperglycemia, contributing to safer pain management protocols for diabetic patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D (Type 2 Diabetes) | Patients diagnosed with Type 2 Diabetes Mellitus who are scheduled for an epidural steroid injection. |
| |
| Group C (Non-Diabetes) | Patients without diabetes who are scheduled for an epidural steroid injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Steroid Injection | Procedure | Administration of 5 mg Dexamethasone via epidural route (cervical or lumbar) under fluoroscopic guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Day 1-2) and up to 12 days post-injection (Day 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. | Baseline (Day 1-2) and up to 12 days post-injection (Day 15) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Day 1) and Day 15 |
| Frequency of Glucose Spikes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients visiting the Pain Clinic at Korea University Anam Hospital who are scheduled for cervical or lumbar epidural steroid injections due to spinal pain.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sunmin Kim, M.D. | Contact | +82-2-920-5632 | k05790@korea.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Sunmin Kim, M.D. | Korea University Anam Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Seoul | Seoul | 02841 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D013130 | Spinal Stenosis |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
| Continuous Glucose Monitoring | Device | A sensor attached to the upper arm to monitor interstitial glucose levels continuously for 15 days. |
|
The number of hyperglycemic events defined as glucose levels >180 mg/dL lasting for at least 30 minutes.
| Up to 12 days post-injection (Day 15) |
| Incidence of Nocturnal Hypoglycemia | The percentage of participants experiencing glucose levels <70 mg/dL during the nighttime period (22:00 to 06:00). | Up to 12 days post-injection (Day 15) |
| 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. | Up to 12 days post-injection (Day 15) |
| D004700 | Endocrine System Diseases |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |