Analysis of Changes in Blood Glucose Spinal Epidural Nerve Block with Steroids in Patients with Low Back Pain

February 7, 2025 updated by: Sung Hyun Lee

Analysis of Changes in Blood Glucose Using a Continuous Blood Glucose Monitoring After Spinal Epidural Nerve Block with Steroids in Patients with Low Back Pain

This study aims to investigate the effect of different doses of dexamethasone used in epidural nerve block procedures on blood sugar levels. Patients with spinal conditions such as stenosis or disc herniation will be enrolled. Blood glucose and HbA1c levels will be measured before the procedure, and participants will use continuous glucose monitoring devices for 2-3 days before the procedure. They will be randomly assigned to one of three groups: no dexamethasone, 5mg dexamethasone, or 7.5mg dexamethasone. Blood glucose will be monitored for one week after the procedure, and follow-up will be done two weeks later to assess pain and blood sugar data. This study will help determine how steroid doses affect blood sugar, especially in elderly patients, and provide more accurate information than previous studies.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • patients need to epidural steroid injection for treating back pain
  • patients diagnosed with diabetes or prediabetes.

Exclusion Criteria:

  • Patients with poorly controlled blood sugar.(HbA1c>8.5)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: dexamethasone dose-0
Procedure: Epidural steroid injection (ESI)
epidural nerve block procedures for patients with spinal conditions such as stenosis or disc herniation
Active Comparator: dexamethasone dose 5.0
Procedure: Epidural steroid injection (ESI)
epidural nerve block procedures for patients with spinal conditions such as stenosis or disc herniation
Active Comparator: dexamethasone dose-7.5
Procedure: Epidural steroid injection (ESI)
epidural nerve block procedures for patients with spinal conditions such as stenosis or disc herniation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose change
Time Frame: glucose change between befor intervention and after for 7days.
glucose change between befor intervention and after for 7days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sung Hyun Lee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Study Registration Dates

First Submitted

February 7, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-12-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Format of data(anonymized datasets).

IPD Sharing Time Frame

Start date: The date when the individual participant data (IPD) and supporting information will first be made available.( starting the study)

End date: The date when access to the IPD and supporting information will no longer be available or when the sharing period ends. (for 3yrs)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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