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

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ClinicalTrials.gov Identifier: NCT01435707
Recruitment Status : Completed
First Posted : September 19, 2011
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
Woo Seog Sim, Samsung Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids
Study Start Date : September 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 1 ]
    before breakfast (fasting state)

  2. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 2 ]
    before breakfast (fasting state)

  3. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 3 ]
  4. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 4 ]
  5. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 5 ]
  6. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 6 ]
  7. fasting blood glucose level [ Time Frame: at 7:00 am of postprocedure day 7 ]
  8. fasting blood glucose [ Time Frame: at 7:00 am of postprocedure day 14 ]

Secondary Outcome Measures :
  1. post-prandial glucose level [ Time Frame: 2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14 ]
    2 hour after dinner

  2. visual analogue scale of subjective pain [ Time Frame: at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14 ]
    at 7:00 am of postprocedure day 5


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435707


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Woo Seog Sim, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01435707    
Other Study ID Numbers: 2011-08-058
First Posted: September 19, 2011    Key Record Dates
Last Update Posted: December 25, 2013
Last Verified: December 2013
Keywords provided by Woo Seog Sim, Samsung Medical Center:
epidural steroid injection
triamcinolone
fasting blood glucose
diabetes mellitus
Additional relevant MeSH terms:
Layout table for MeSH terms
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
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