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

NCT06818617 | Not Yet Recruiting DMC

• 1 other identifier: 2024-12-014
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glucose Level Change

Keywords

continous glucose monitering

Outcome Measures

Primary Outcomes (1)

• Glucose change

  glucose change between befor intervention and after for 7days.

Study Arms (3)

dexamethasone dose-0

ACTIVE COMPARATOR

Procedure: Epidural steroid injection (ESI)

dexamethasone dose 5.0

ACTIVE COMPARATOR

Procedure: Epidural steroid injection (ESI)

dexamethasone dose-7.5

ACTIVE COMPARATOR

Procedure: Epidural steroid injection (ESI)

Interventions

Epidural steroid injection (ESI) PROCEDURE

epidural nerve block procedures for patients with spinal conditions such as stenosis or disc herniation

dexamethasone dose 5.0; dexamethasone dose-0; dexamethasone dose-7.5

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sung Hyun Lee: lead

Central Study Contacts

Sung Hyun Lee

CONTACT

82-2-2001-2001; hoho4321.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Kangbuk Samsung Hospital

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 10, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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)