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

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Low Back Pain

Intervention: 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 (Other)

Phase: N/A

Status: Completed

Sponsored by: Samsung Medical Center

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome:

fasting blood glucose level

fasting blood glucose level

fasting blood glucose level

fasting blood glucose level

fasting blood glucose level

fasting blood glucose level

fasting blood glucose level

fasting blood glucose

Secondary outcome:

post-prandial glucose level

visual analogue scale of subjective pain

Detailed description: 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.

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Samsung Medical Center, Seoul 135-710, Korea, Republic of
Additional Information

Starting date: September 2011
Last updated: December 24, 2013

Page last updated: August 23, 2015

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