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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: caudal epidural steroid injection with Triamcinolone 20mg; Other: Selective transforaminal epidural block with triamcinolone 40 mg; Other: epidural steroid injection with Triamcinolone 40mg; Other: Selective transforaminal epidural block with triamcinolone 20 mg

• Registration Number: NCT01435707
• Lead Sponsor: Samsung Medical Center

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 Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-24
• Last Update Posted: 2013-12-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal 20 mg	caudal epidural steroid injection with Triamcinolone 20mg	subjects who undergo caudal epidural block with triamcinolone 20 mg
STE 40 group	Selective transforaminal epidural block with triamcinolone 40 mg	subjects who undergo selective transforaminal block with triamcinolone 40 mg
Caudal 40 group	epidural steroid injection with Triamcinolone 40mg	subjects who undergo caudal epidural block with triamcinolone 40 mg
STE 20 group	Selective transforaminal epidural block with triamcinolone 20 mg	subjects who undergo selective transforaminal block with triamcinolone 20 mg

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of