The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids

Study Overview
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Brief Summary
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There has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. Previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. Therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

Detailed Description
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It is well known that blood glucose level is elevated in diabetes patients more than non-diabetes patients who underwent the epidural steroid injection. However, there has been no reports of the effect of various kinds of steroid or various dose of steroid which are commonly used in the clinical setting. Previous studies have simply shown that the blood glucose level is elevated in diabetes patients and did not show or suggest the adequate strategy of epidural steroid injection in diabetes patients regarding steroid type, dosage or injection interval. Therefore, the investigators tried to evaluate the effect of different dosage of triamcinolone, which is a commonly used steroid in epidural steroid injection, on the blood glucose level.

Official Title
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The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: epidural steroid injection with Triamcinolone 40mg
* Other: Selective transforaminal epidural block with triamcinolone 20 mg
* Other: caudal epidural steroid injection with Triamcinolone 20mg
* Other: Selective transforaminal epidural block with triamcinolone 40 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic subjects older than 20 yrs. Exclusion Criteria: ASA (American society of Anesthesiologists class) III or more severe cardiopulmonary disease or brain disorder Subjects diagnosed uncontrolled diabetes with complications subjects undergoing hormone therapy subjects with active infection subjects with pregnancy subjects with recent stress condition such as surgery or trauma subjects with active neurologic disorder those with anticoagulation therapy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caudal 40 group<br>subjects who undergo caudal epidural block with triamcinolone 40 mg | Other: epidural steroid injection with Triamcinolone 40mg<br>* epidural steroid injection with Triamcinolone 40mg<br>* Other names: caudal epidural block;|
| Experimental: STE 20 group<br>subjects who undergo selective transforaminal block with triamcinolone 20 mg | Other: Selective transforaminal epidural block with triamcinolone 20 mg<br>* Selective transforaminal epidural block with triamcinolone 20 mg<br>* Other names: epidural steroid injection;|
| Experimental: Caudal 20 mg<br>subjects who undergo caudal epidural block with triamcinolone 20 mg | Other: caudal epidural steroid injection with Triamcinolone 20mg<br>* caudal epidural steroid injection with Triamcinolone 20mg<br>* Other names: caudal epidural block;|
| Experimental: STE 40 group<br>subjects who undergo selective transforaminal block with triamcinolone 40 mg | Other: Selective transforaminal epidural block with triamcinolone 40 mg<br>* Selective transforaminal epidural block with triamcinolone 40 mg<br>* Other names: epidural steroid injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose level | before breakfast (fasting state) | at 7:00 am of postprocedure day 1 | 
| fasting blood glucose level | before breakfast (fasting state) | at 7:00 am of postprocedure day 2 | 
| fasting blood glucose level |  | at 7:00 am of postprocedure day 3 | 
| fasting blood glucose level |  | at 7:00 am of postprocedure day 4 | 
| fasting blood glucose level |  | at 7:00 am of postprocedure day 5 | 
| fasting blood glucose level |  | at 7:00 am of postprocedure day 6 | 
| fasting blood glucose level |  | at 7:00 am of postprocedure day 7 | 
| fasting blood glucose |  | at 7:00 am of postprocedure day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-prandial glucose level | 2 hour after dinner | 2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14 | 
| visual analogue scale of subjective pain | at 7:00 am of postprocedure day 5 | at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural steroid injection, triamcinolone, fasting blood glucose, diabetes mellitus