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

NCT01435707 | Completed

• 1 other identifier: 2011-08-058
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

epidural steroid injection; triamcinolone; fasting blood glucose; diabetes mellitus

Outcome Measures

Primary Outcomes (8)

• fasting blood glucose level

  before breakfast (fasting state)

  at 7:00 am of postprocedure day 1

• fasting blood glucose level

  before breakfast (fasting state)

  at 7:00 am of postprocedure day 2

• fasting blood glucose level

  at 7:00 am of postprocedure day 3

• fasting blood glucose level

  at 7:00 am of postprocedure day 4

• fasting blood glucose level

  at 7:00 am of postprocedure day 5

• fasting blood glucose level

  at 7:00 am of postprocedure day 6

• fasting blood glucose level

  at 7:00 am of postprocedure day 7

• fasting blood glucose

  at 7:00 am of postprocedure day 14

Secondary Outcomes (2)

• post-prandial glucose level

  2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14

• visual analogue scale of subjective pain

  at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14

Study Arms (4)

Caudal 40 group

EXPERIMENTAL

subjects who undergo caudal epidural block with triamcinolone 40 mg

Other: epidural steroid injection with Triamcinolone 40mg

STE 20 group

EXPERIMENTAL

subjects who undergo selective transforaminal block with triamcinolone 20 mg

Other: Selective transforaminal epidural block with triamcinolone 20 mg

Caudal 20 mg

EXPERIMENTAL

subjects who undergo caudal epidural block with triamcinolone 20 mg

Other: caudal epidural steroid injection with Triamcinolone 20mg

STE 40 group

EXPERIMENTAL

subjects who undergo selective transforaminal block with triamcinolone 40 mg

Other: Selective transforaminal epidural block with triamcinolone 40 mg

Interventions

epidural steroid injection with Triamcinolone 40mg OTHER

epidural steroid injection with Triamcinolone 40mg

Also known as: Triamcinolone, epidural steroid injection, caudal epidural block

Caudal 40 group

Selective transforaminal epidural block with triamcinolone 20 mg OTHER

Selective transforaminal epidural block with triamcinolone 20 mg

Also known as: selective transforaminal block, Triamcinolone, epidural steroid injection

STE 20 group

caudal epidural steroid injection with Triamcinolone 20mg OTHER

caudal epidural steroid injection with Triamcinolone 20mg

Also known as: Triamcinolone, epidural steroid injection, caudal epidural block

Caudal 20 mg

Selective transforaminal epidural block with triamcinolone 40 mg OTHER

Selective transforaminal epidural block with triamcinolone 40 mg

Also known as: selective transforaminal block, Triamcinolone, epidural steroid injection

STE 40 group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic
• subjects older than 20 yrs.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (1)

• 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.

  PMID: 24284841 DERIVED

MeSH Terms

Conditions

Low Back Pain; Diabetes Mellitus

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (1)