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

This study is currently recruiting participants.

Verified February 2012 by Samsung Medical Center

Sponsor:

Information provided by (Responsible Party):

Woo Seog Sim, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01435707

First received: September 15, 2011

Last updated: February 8, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 15, 2011

Last Updated Date

February 8, 2012

Start Date ^ICMJE

September 2011

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 1 ] [ Designated as safety issue: No ]
before breakfast (fasting state)
fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 2 ] [ Designated as safety issue: No ]
before breakfast (fasting state)
fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 3 ] [ Designated as safety issue: No ]
fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 4 ] [ Designated as safety issue: No ]
fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 5 ] [ Designated as safety issue: No ]
fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 6 ] [ Designated as safety issue: No ]
fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 7 ] [ Designated as safety issue: No ]
fasting blood glucose [ Time Frame: at 7:00 am of postprocedure day 14 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01435707 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

post-prandial glucose level [ Time Frame: 2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14 ] [ Designated as safety issue: No ]
2 hour after dinner
visual analogue scale of subjective pain [ Time Frame: at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14 ] [ Designated as safety issue: No ]
at 7:00 am of postprocedure day 5

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Other: epidural steroid injection with Triamcinolone 40mg
epidural steroid injection with Triamcinolone 40mg
Other Names:
- Triamcinolone
- epidural steroid injection
- caudal epidural block
Other: Selective transforaminal epidural block with triamcinolone 20 mg
Selective transforaminal epidural block with triamcinolone 20 mg
Other Names:
- selective transforaminal block
- Triamcinolone
- epidural steroid injection
Other: caudal epidural steroid injection with Triamcinolone 20mg
caudal epidural steroid injection with Triamcinolone 20mg
Other Names:
- Triamcinolone
- epidural steroid injection
- caudal epidural block
Other: Selective transforaminal epidural block with triamcinolone 40 mg
Selective transforaminal epidural block with triamcinolone 40 mg
Other Names:
- selective transforaminal block
- Triamcinolone
- epidural steroid injection

Study Arm (s)

Experimental: Caudal 40 group
subjects who undergo caudal epidural block with triamcinolone 40 mg

Intervention: Other: epidural steroid injection with Triamcinolone 40mg
Experimental: STE 20 group
subjects who undergo selective transforaminal block with triamcinolone 20 mg

Intervention: Other: Selective transforaminal epidural block with triamcinolone 20 mg
Experimental: Caudal 20 mg
subjects who undergo caudal epidural block with triamcinolone 20 mg

Intervention: Other: caudal epidural steroid injection with Triamcinolone 20mg
Experimental: STE 40 group
subjects who undergo selective transforaminal block with triamcinolone 40 mg

Intervention: Other: Selective transforaminal epidural block with triamcinolone 40 mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Woo Seog Sim, M.D.,Ph.D.	82-2-3410-0356	wooseog.sim@samsung.com
Contact: Won Ho Kim, M.D.	82-2-3410-1994	bullet57@naver.com

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01435707

Other Study ID Numbers ^ICMJE

2011-08-058

Has Data Monitoring Committee

Responsible Party

Woo Seog Sim, Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Samsung Medical Center

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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