Low Back PainNCT01435707
The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids
A study testing epidural steroid injection with Triamcinolone 40mg, Selective transforaminal epidural block with triamcinolone 20 mg and caudal epidural steroid injection with Triamcinolone 20mg in people with Low Back Pain, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- epidural steroid injection with Triamcinolone 40mg, Selective transforaminal epidural block with triamcinolone 20 mg and caudal epidural steroid injection with Triamcinolone 20mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2011to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic
- subjects older than 20 yrs.
Who cannot join
- 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
Show all 9Show fewer
- subjects with recent stress condition such as surgery or trauma
- subjects with active neurologic disorder
- those with anticoagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Low Back Pain
- Being tested
- epidural steroid injection with Triamcinolone 40mg, Selective transforaminal epidural block with triamcinolone 20 mg, caudal epidural steroid injection with Triamcinolone 20mg, Selective transforaminal epidural block with triamcinolone 40 mg
- Keywords
- epidural steroid injection, triamcinolone, fasting blood glucose, diabetes mellitus
- Medical subject headings
- Low Back Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural steroid injection with Triamcinolone 40mgOther
Also called Triamcinolone, epidural steroid injection, caudal epidural block
epidural steroid injection with Triamcinolone 40mg
Selective transforaminal epidural block with triamcinolone 20 mgOther
Also called selective transforaminal block, Triamcinolone, epidural steroid injection
Selective transforaminal epidural block with triamcinolone 20 mg
caudal epidural steroid injection with Triamcinolone 20mgOther
Also called Triamcinolone, epidural steroid injection, caudal epidural block
caudal epidural steroid injection with Triamcinolone 20mg
Selective transforaminal epidural block with triamcinolone 40 mgOther
Also called selective transforaminal block, Triamcinolone, epidural steroid injection
Selective transforaminal epidural block with triamcinolone 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Caudal 40 group | Experimental | subjects who undergo caudal epidural block with triamcinolone 40 mg Receives: Other: epidural steroid injection with Triamcinolone 40mg |
| STE 20 group | Experimental | subjects who undergo selective transforaminal block with triamcinolone 20 mg Receives: Other: Selective transforaminal epidural block with triamcinolone 20 mg |
| Caudal 20 mg | Experimental | subjects who undergo caudal epidural block with triamcinolone 20 mg Receives: Other: caudal epidural steroid injection with Triamcinolone 20mg |
| STE 40 group | Experimental | subjects who undergo selective transforaminal block with triamcinolone 40 mg Receives: Other: Selective transforaminal epidural block with triamcinolone 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose level
before breakfast (fasting state)
Measured: at 7:00 am of postprocedure day 1
fasting blood glucose level
before breakfast (fasting state)
Measured: at 7:00 am of postprocedure day 2
fasting blood glucose level
Measured: at 7:00 am of postprocedure day 3
fasting blood glucose level
Measured: at 7:00 am of postprocedure day 4
fasting blood glucose level
Measured: at 7:00 am of postprocedure day 5
fasting blood glucose level
Measured: at 7:00 am of postprocedure day 6
fasting blood glucose level
Measured: at 7:00 am of postprocedure day 7
fasting blood glucose
Measured: at 7:00 am of postprocedure day 14
Secondary outcomes (2)
post-prandial glucose level
2 hour after dinner
Measured: 2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14
visual analogue scale of subjective pain
at 7:00 am of postprocedure day 5
Measured: at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woo Seog Sim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435707
- Sponsor's protocol ID
- 2011-08-058
- Status last verified
- Dec 2013
- First submitted
- 15 Sep 2011
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24284841
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Steroid Injections on Glycemic Control in Diabetic Patients According to the Doses of Steroids
- ClinicalTrials.gov ID
- NCT01435707
- Acronym / sponsor ID
- 2011-08-058
- Conditions
- Low Back Pain
- Keywords
- epidural steroid injection, triamcinolone, fasting blood glucose, diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caudal 40 group | Experimental | Other: epidural steroid injection with Triamcinolone 40mgsubjects who undergo caudal epidural block with triamcinolone 40 mg |
| STE 20 group | Experimental | Other: Selective transforaminal epidural block with triamcinolone 20 mgsubjects who undergo selective transforaminal block with triamcinolone 20 mg |
| Caudal 20 mg | Experimental | Other: caudal epidural steroid injection with Triamcinolone 20mgsubjects who undergo caudal epidural block with triamcinolone 20 mg |
| STE 40 group | Experimental | Other: Selective transforaminal epidural block with triamcinolone 40 mgsubjects who undergo selective transforaminal block with triamcinolone 40 mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects who undergo epidural steroid injection (caudal epidural injection or selective transforaminal block) in the pain medicine outpatient clinic
- subjects older than 20 yrs.
Key exclusion criteria (9 listed)
- 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
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 with Triamcinolone 40mgAlso: Triamcinolone, epidural steroid injection, caudal epidural blockepidural steroid injection with Triamcinolone 40mg | Other | Caudal 40 group |
| Selective transforaminal epidural block with triamcinolone 20 mgAlso: selective transforaminal block, Triamcinolone, epidural steroid injectionSelective transforaminal epidural block with triamcinolone 20 mg | Other | STE 20 group |
| caudal epidural steroid injection with Triamcinolone 20mgAlso: Triamcinolone, epidural steroid injection, caudal epidural blockcaudal epidural steroid injection with Triamcinolone 20mg | Other | Caudal 20 mg |
| Selective transforaminal epidural block with triamcinolone 40 mgAlso: selective transforaminal block, Triamcinolone, epidural steroid injectionSelective transforaminal epidural block with triamcinolone 40 mg | Other | STE 40 group |
Primary outcome
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 1
before breakfast (fasting state)
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 2
before breakfast (fasting state)
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 3
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 4
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 5
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 6
fasting blood glucose level
Time frame: at 7:00 am of postprocedure day 7
fasting blood glucose
Time frame: at 7:00 am of postprocedure day 14
2 secondary outcomes
post-prandial glucose level
Time frame: 2 hour after dinner at postprandial day 1, 2, 3, 4, 5, 6, 7, 14
visual analogue scale of subjective pain
Time frame: at 7 p.m. of postprocedure day 1, 2, 3, 4, 5, 6, 7, 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
- Derived from this study: PubMed 24284841Kim 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.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural steroid injection with Triamcinolone 40mg, Selective transforaminal epidural block with triamcinolone 20 mg and caudal epidural steroid injection with Triamcinolone 20mg in people with Low Back Pain, run by Samsung Medical Center at 1 site in South Korea.
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 9 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: finished, as of the sponsor's last update on 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glucose level (time frame: at 7:00 am of postprocedure day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435707, which also lists 1 linked publication.
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 25 Dec 2013.