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

This study is currently recruiting participants.
Verified February 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Woo Seog Sim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01435707
First received: September 15, 2011
Last updated: February 8, 2012
Last verified: February 2012
History of Changes
  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:

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


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435707

Contacts
Contact: Woo Seog Sim, M.D.,Ph.D. 82-2-3410-0356 wooseog.sim@samsung.com
Contact: Won Ho Kim, M.D. 82-2-3410-1994 bullet57@naver.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Woo Seog Sim, M.D.,Ph.D.     82-2-3410-0356     wooseog.sim@samsung.com    
Contact: Won Ho Kim, M.D.     82-2-3410-1994     bullet57@naver.com    
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

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: February 8, 2012
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
 Therapeutic Uses
Pharmacologic Actions
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 May 19, 2013