Glucose Level ChangeNCT06818617
Analysis of Changes in Blood Glucose Spinal Epidural Nerve Block with Steroids in Patients with Low Back Pain
A study testing Epidural steroid injection (ESI) in people with Glucose Level Change, run by Sung Hyun Lee.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Level Change
- What is being tested?
- Epidural steroid injection (ESI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients need to epidural steroid injection for treating back pain
- patients diagnosed with diabetes or prediabetes.
Who cannot join
- Patients with poorly controlled blood sugar.(HbA1c>8.5)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Glucose Level Change
- Being tested
- Epidural steroid injection (ESI)
- Keywords
- continous glucose monitering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural steroid injection (ESI)Procedure or surgery
epidural nerve block procedures for patients with spinal conditions such as stenosis or disc herniation
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone dose-0 | Active comparator | Not described Receives: Procedure: Epidural steroid injection (ESI) |
| dexamethasone dose 5.0 | Active comparator | Not described Receives: Procedure: Epidural steroid injection (ESI) |
| dexamethasone dose-7.5 | Active comparator | Not described Receives: Procedure: Epidural steroid injection (ESI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose change
Measured: glucose change between befor intervention and after for 7days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start19 Feb 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Level ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung Hyun Lee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sung Hyun Lee, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818617
- Sponsor's protocol ID
- 2024-12-014
- Status last verified
- Feb 2025
- First submitted
- 7 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Format of data(anonymized datasets).
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06818617
- Acronym / sponsor ID
- 2024-12-014
- Conditions
- Glucose Level Change
- Keywords
- continous glucose monitering
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sung Hyun LeeUniversity, hospital or other
- Study start
- 19 Feb 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients need to epidural steroid injection for treating back pain
- patients diagnosed with diabetes or prediabetes.
Key exclusion criteria (1 listed)
- Patients with poorly controlled blood sugar.(HbA1c>8.5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural steroid injection (ESI)epidural nerve block procedures for patients with spinal conditions such as stenosis or disc herniation | Procedure or surgery | dexamethasone dose 5.0, dexamethasone dose-0, dexamethasone dose-7.5 |
Primary outcome
Glucose change
Time frame: glucose change between befor intervention and after for 7days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Yes. Format of data(anonymized datasets).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural steroid injection (ESI) in people with Glucose Level Change, run by Sung Hyun Lee.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung Hyun Lee (82-2-2001-2001, hoho4321.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose change (time frame: glucose change between befor intervention and after for 7days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.