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

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 Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: 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

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: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caudal 40 group; subjects who undergo caudal epidural block with triamcinolone 40 mg	Other: epidural steroid injection with Triamcinolone 40mg; epidural steroid injection with Triamcinolone 40mg; Other Names: Triamcinolone; epidural steroid injection; caudal epidural block
Experimental: STE 20 group; subjects who undergo selective transforaminal block with triamcinolone 20 mg	Other: Selective transforaminal epidural block with triamcinolone 20 mg; Selective transforaminal epidural block with triamcinolone 20 mg; Other Names: Triamcinolone; epidural steroid injection; selective transforaminal block
Experimental: Caudal 20 mg; subjects who undergo caudal epidural block with triamcinolone 20 mg	Other: caudal epidural steroid injection with Triamcinolone 20mg; caudal epidural steroid injection with Triamcinolone 20mg; Other Names: Triamcinolone; epidural steroid injection; caudal epidural block
Experimental: STE 40 group; subjects who undergo selective transforaminal block with triamcinolone 40 mg	Other: Selective transforaminal epidural block with triamcinolone 40 mg; Selective transforaminal epidural block with triamcinolone 40 mg; Other Names: Triamcinolone; epidural steroid injection; selective transforaminal block

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 25, 2013
• Last Update Submitted That Met QC Criteria: December 24, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: triamcinolone; diabetes mellitus; epidural steroid injection; fasting blood glucose
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 2011-08-058