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

Purpose

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.

Condition	Intervention
Low Back Pain	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


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject)
Official Title:	The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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


Enrollment:	125
Study Start Date:	September 2011
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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: selective transforaminal block Triamcinolone epidural steroid injection
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: selective transforaminal block Triamcinolone epidural steroid injection

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


Ages Eligible for Study:	20 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435707

Locations


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

Sponsors and Collaborators

Samsung Medical Center

More Information


Responsible Party:	Woo Seog Sim, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01435707 History of Changes
Other Study ID Numbers:	2011-08-058
Study First Received:	September 15, 2011
Last Updated:	December 24, 2013
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:


epidural steroid injection triamcinolone fasting blood glucose diabetes mellitus

Additional relevant MeSH terms:


Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate	Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016