Lumbar Disc HerniationNCT07184554
Lumbar Disc Hernia, Erector Spinae Plane Block, Ilesi
A study testing us-guided espb and fl-guided Ilesi in people with Lumbar Disc Herniation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The study is designed as an observational study. Patients who have been treated and completed treatment for lumbar discopathy in our clinic will be followed. Patients will not be divided into groups beforehand, and this will not cause changes to the treatment plan. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- us-guided espb and fl-guided Ilesi
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2025to 30 Dec 2025
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic low back pain caused by L4-L5 and L5-S1 lumbar disc herniation accompanied by radicular pain, including those diagnosed by MRI, will be included.
- Patients with low back pain above VAS 5 for more than 6 weeks will be included.
- Failure of pain treatment with conservative methods such as analgesics and physical therapy
Who cannot join
- Patients who have previously undergone lumbar surgery,
- Patients with spinal deformity and stenosis,
- Patients with uncontrolled diabetes
- Patients allergic to the drugs to be used will not be included in the study.
- Presence of psychiatric comorbidity
- Local or systemic infection
- Coagulopathy
- Presence of rheumatological disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara
About this study
Official title: Comparison of the Effectiveness of Lumbar Erector Spinae Plane Block and Lumbar Interlaminar Epidural Steroid Injection in Patients With Lumbar Disc Herniation.
The study is designed as an observational study. Patients who have been treated and completed treatment for lumbar discopathy in our clinic will be followed. Patients will not be divided into groups beforehand, and this will not cause changes to the treatment plan. Patients who have undergone fluoroscopy-guided lumbar interlaminar epidural steroid injection (LESI) and ultrasound-guided lumbar erector spinae plane block (LESP), routinely performed in our clinic for the treatment of back and leg pain due to lumbar disc herniation, will be compared to the effectiveness of these methods on pain at baseline before the procedure and at 2, 6, and 12 weeks afterward using the Visual Analogue Scale for Pain Relief (VAS) and Oswestry Disability Index (ODI). The baseline values will be recorded from the patient files and by request before the start of follow-up.
Read the detailed description
Chronic low back pain (>3 months) is one of the chronic pain syndromes that most significantly impairs functionality. Lumbar disc herniation is one of the most common spinal degenerative conditions causing low back pain and radicular leg pain. Treatment options for this condition in pain clinics include minimally invasive treatments such as paravertebral plane blocks and epidural steroid injections. The use of interventional methods for low back pain has been increasing in recent years. The primary reason for this is the desire of patients who fail to achieve adequate relief with conservative treatment methods such as medical therapy and physical therapy to try relatively conservative methods before surgery. Two commonly used interventions for patients with lumbar disc herniation who do not respond to conservative treatment methods are fluoroscopy-guided LESI and ultrasound-guided LESP block, which we frequently perform in our clinic.
Patients who have undergone routine LESP and LESI in our clinic and who meet the inclusion criteria will be included in the study. Pain intensity and functionality will be assessed using the visual analog pain score and the Oswestry disability index.
- Conditions
- Lumbar Disc Herniation
- Being tested
- us-guided espb, fl-guided Ilesi
- Keywords
- espb, lesi, lumbar disc herniation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
us-guided espbProcedure or surgery
Hemodynamic monitoring is provided. The lumbar region where the procedure will be performed is cleaned with povidone iodine. Sterile draping is provided. For the lumbar erector spinae plane block application, a 5 Hz convex ultrasound probe is first placed sagittally over the desired level of the lumbar vertebra. After the spinous processes are visualized, the ultrasound probe is laterally shifted in the sagittal plane, first visualizing the laminae, then the facet joints, and finally the transverse processes. The erector spinae muscles are visualized over the transverse processes. The skin and subcutaneous tissue are then anesthetized with 2 cc of 2% lidocaine. A spinal needle is inserted from the anesthetized area in the same plane as the ultrasound probe (in plane) and contacts the relevant transverse process. Thanks to the real-time imaging advantage of ultrasound, a certain distance is maintained from the nerves and vascular structures. Once the appropriate location is reached, a m
fl-guided IlesiProcedure or surgery
For lumbar interlaminar epidural steroid injection, the anterior view of the desired level is obtained under fluoroscopy to visualize the relevant interlaminar epidural space. The skin and subcutaneous tissue are anesthetized with a local anesthetic. A paramedian approach is used to enter the target interlaminar space with an epidural needle using a negative pressure injector. The lateral view is checked using fluoroscopy. 2 cc of opaque material is administered, and its presence in the epidural space is confirmed from the lateral and anterior-posterior views. A mixture of steroid and local anesthetic (8 mg dexamethasone, 3 cc 5mg/ml bupivacaine, and SF for a total of 10 cc) is injected. The needle is removed in a controlled manner and the needle site is closed. After the procedure, patients are monitored in the recovery unit for 60 minutes and then transferred to the ward for follow-up. Patients who have completed their 1-hour follow-up in the ward are discharged.
| Study group | Role | What they receive |
|---|---|---|
| us-guided espb | Active comparator | us-guided espb for ldh Receives: Procedure: us-guided espb |
| fl-guided Ilesi | Active comparator | fl-guided Ilesi for ldh Receives: Procedure: fl-guided Ilesi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to 2nd, 6th and 12th weeks after treatment
Secondary outcomes (1)
oswestry disability index
The Oswestry Disability Index is an index derived from the Oswestry Back Pain Questionnaire, which is used by clinicians and researchers to measure disability in terms of back pain and quality of life.
Measured: Change from baseline to 2nd, 6th and 12th weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184554
- Sponsor's protocol ID
- Ilesi block vs esp
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Lumbar Erector Spinae Plane Block and Lumbar Interlaminar Epidural Steroid Injection in Patients With Lumbar Disc Herniation.
- ClinicalTrials.gov ID
- NCT07184554
- Acronym / sponsor ID
- Ilesi block vs esp
- Conditions
- Lumbar Disc Herniation
- Keywords
- espb, lesi, lumbar disc herniation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Sep 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.
The study is designed as an observational study. Patients who have been treated and completed treatment for lumbar discopathy in our clinic will be followed. Patients will not be divided into groups beforehand, and this will not cause changes to the treatment plan. Patients who have undergone fluoroscopy-guided lumbar interlaminar epidural steroid injection (LESI) and ultrasound-guided lumbar erector spinae plane block (LESP), routinely performed in our clinic for the treatment of back and leg pain due to lumbar disc herniation, will be compared to the effectiveness of these methods on pain at baseline before the procedure and at 2, 6, and 12 weeks afterward using the Visual Analogue Scale for Pain Relief (VAS) and Oswestry Disability Index (ODI). The baseline values will be recorded from the patient files and by request before the start of follow-up.
Detailed description
Chronic low back pain (>3 months) is one of the chronic pain syndromes that most significantly impairs functionality. Lumbar disc herniation is one of the most common spinal degenerative conditions causing low back pain and radicular leg pain. Treatment options for this condition in pain clinics include minimally invasive treatments such as paravertebral plane blocks and epidural steroid injections. The use of interventional methods for low back pain has been increasing in recent years. The primary reason for this is the desire of patients who fail to achieve adequate relief with conservative treatment methods such as medical therapy and physical therapy to try relatively conservative methods before surgery. Two commonly used interventions for patients with lumbar disc herniation who do not respond to conservative treatment methods are fluoroscopy-guided LESI and ultrasound-guided LESP block, which we frequently perform in our clinic.
Patients who have undergone routine LESP and LESI in our clinic and who meet the inclusion criteria will be included in the study. Pain intensity and functionality will be assessed using the visual analog pain score and the Oswestry disability index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| us-guided espb | Active comparator | Procedure: us-guided espbus-guided espb for ldh |
| fl-guided Ilesi | Active comparator | Procedure: fl-guided Ilesifl-guided Ilesi for ldh |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with chronic low back pain caused by L4-L5 and L5-S1 lumbar disc herniation accompanied by radicular pain, including those diagnosed by MRI, will be included.
- Patients with low back pain above VAS 5 for more than 6 weeks will be included.
- Failure of pain treatment with conservative methods such as analgesics and physical therapy
Key exclusion criteria (8 listed)
- Patients who have previously undergone lumbar surgery,
- Patients with spinal deformity and stenosis,
- Patients with uncontrolled diabetes
- Patients allergic to the drugs to be used will not be included in the study.
- Presence of psychiatric comorbidity
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 |
|---|---|---|
| us-guided espbHemodynamic monitoring is provided. The lumbar region where the procedure will be performed is cleaned with povidone iodine. Sterile draping is provided. For the lumbar erector spinae plane block application, a 5 Hz convex ultrasound probe is first placed sagittally over the desired level of the lumbar vertebra. After the spinous processes are visualized, the ultrasound probe is laterally shifted in the sagittal plane, first visualizing the laminae, then the facet joints, and finally the transverse processes. The erector spinae muscles are visualized over the transverse processes. The skin and subcutaneous tissue are then anesthetized with 2 cc of 2% lidocaine. A spinal needle is inserted from the anesthetized area in the same plane as the ultrasound probe (in plane) and contacts the relevant transverse process. Thanks to the real-time imaging advantage of ultrasound, a certain distance is maintained from the nerves and vascular structures. Once the appropriate location is reached, a m | Procedure or surgery | us-guided espb |
| fl-guided IlesiFor lumbar interlaminar epidural steroid injection, the anterior view of the desired level is obtained under fluoroscopy to visualize the relevant interlaminar epidural space. The skin and subcutaneous tissue are anesthetized with a local anesthetic. A paramedian approach is used to enter the target interlaminar space with an epidural needle using a negative pressure injector. The lateral view is checked using fluoroscopy. 2 cc of opaque material is administered, and its presence in the epidural space is confirmed from the lateral and anterior-posterior views. A mixture of steroid and local anesthetic (8 mg dexamethasone, 3 cc 5mg/ml bupivacaine, and SF for a total of 10 cc) is injected. The needle is removed in a controlled manner and the needle site is closed. After the procedure, patients are monitored in the recovery unit for 60 minutes and then transferred to the ward for follow-up. Patients who have completed their 1-hour follow-up in the ward are discharged. | Procedure or surgery | fl-guided Ilesi |
Primary outcome
Visual analog scale (VAS)
Time frame: Change from baseline to 2nd, 6th and 12th weeks after treatment
VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
1 secondary outcome
oswestry disability index
Time frame: Change from baseline to 2nd, 6th and 12th weeks after treatment
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 25 Sep 2025.
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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.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing us-guided espb and fl-guided Ilesi in people with Lumbar Disc Herniation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Turkey (Türkiye). 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?
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 EMINE YUKSEL (+905453489378 ext. TR, eminecan_02@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (VAS) (time frame: Change from baseline to 2nd, 6th and 12th weeks after treatment). 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 25 Sep 2025.