Clinical trial NCT01435707: The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids
Official title: The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: epidural steroid injection
triamcinolone
fasting blood glucose
diabetes mellitus
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-09-19
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 1
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 2
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 3
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 4
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 5
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 6
measure: fasting blood glucose level
timeFrame: at 7:00 am of postprocedure day 7
measure: fasting blood glucose
timeFrame: at 7:00 am of postprocedure day 14
Secondary outcomes:
measure: post-prandial glucose level
timeFrame: 2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14
measure: visual analogue scale of subjective pain
timeFrame: at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: 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.