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Completed

NCT Number: NCT01435707

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural steroid injection with Triamcinolone 40mg

Other

epidural steroid injection with Triamcinolone 40mg

Other names: Triamcinolone, epidural steroid injection, caudal epidural block

Selective transforaminal epidural block with triamcinolone 20 mg

Other

Selective transforaminal epidural block with triamcinolone 20 mg

Other names: selective transforaminal block, Triamcinolone, epidural steroid injection

caudal epidural steroid injection with Triamcinolone 20mg

Other

caudal epidural steroid injection with Triamcinolone 20mg

Other names: Triamcinolone, epidural steroid injection, caudal epidural block

Selective transforaminal epidural block with triamcinolone 40 mg

Other

Selective transforaminal epidural block with triamcinolone 40 mg

Other names: selective transforaminal block, Triamcinolone, epidural steroid injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2011
Registry last updated
Dec 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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