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

NCT ID: NCT01435707

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-03-31

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.

Conditions

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Low Back Pain

Keywords

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epidural steroid injection triamcinolone fasting blood glucose diabetes mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Caudal 40 group

subjects who undergo caudal epidural block with triamcinolone 40 mg

Group Type EXPERIMENTAL

epidural steroid injection with Triamcinolone 40mg

Intervention Type OTHER

epidural steroid injection with Triamcinolone 40mg

STE 20 group

subjects who undergo selective transforaminal block with triamcinolone 20 mg

Group Type EXPERIMENTAL

Selective transforaminal epidural block with triamcinolone 20 mg

Intervention Type OTHER

Selective transforaminal epidural block with triamcinolone 20 mg

Caudal 20 mg

subjects who undergo caudal epidural block with triamcinolone 20 mg

Group Type EXPERIMENTAL

caudal epidural steroid injection with Triamcinolone 20mg

Intervention Type OTHER

caudal epidural steroid injection with Triamcinolone 20mg

STE 40 group

subjects who undergo selective transforaminal block with triamcinolone 40 mg

Group Type EXPERIMENTAL

Selective transforaminal epidural block with triamcinolone 40 mg

Intervention Type OTHER

Selective transforaminal epidural block with triamcinolone 40 mg

Interventions

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epidural steroid injection with Triamcinolone 40mg

epidural steroid injection with Triamcinolone 40mg

Intervention Type OTHER

Selective transforaminal epidural block with triamcinolone 20 mg

Selective transforaminal epidural block with triamcinolone 20 mg

Intervention Type OTHER

caudal epidural steroid injection with Triamcinolone 20mg

caudal epidural steroid injection with Triamcinolone 20mg

Intervention Type OTHER

Selective transforaminal epidural block with triamcinolone 40 mg

Selective transforaminal epidural block with triamcinolone 40 mg

Intervention Type OTHER

Other Intervention Names

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Triamcinolone epidural steroid injection caudal epidural block selective transforaminal block Triamcinolone epidural steroid injection Triamcinolone epidural steroid injection caudal epidural block selective transforaminal block Triamcinolone epidural steroid injection

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Woo Seog Sim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim WH, Sim WS, Shin BS, Lee CJ, Jin HS, Lee JY, Roe HJ, Kim CS, Lee SM. Effects of two different doses of epidural steroid on blood glucose levels and pain control in patients with diabetes mellitus. Pain Physician. 2013 Nov-Dec;16(6):557-68.

Reference Type DERIVED
PMID: 24284841 (View on PubMed)

Other Identifiers

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2011-08-058

Identifier Type: -

Identifier Source: org_study_id