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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Woo Seog Sim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01435707
First received: September 15, 2011
Last updated: December 24, 2013
Last verified: December 2013

September 15, 2011
December 24, 2013
September 2011
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01435707 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Low Back Pain
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01435707
2011-08-058
No
Woo Seog Sim, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
December 2013

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