Lumbar Disc HerniationNCT05719792
Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Injections
An observational study of Lumbar Disc Herniation and Radiculopathy Lumbar, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Disc Herniation, Radiculopathy Lumbar
- What is being tested?
- Transforaminal Epidural Steroid Injection and Erector Spina Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Aug 2023
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study group will consist of patients who are planned to receive transforaminal epidural steroid injection or erector spina plane block treatment by the clinician, and who want to participate in the study.
Who may be able to join
- Being between the ages of 18-65
- Radicular low back pain
- Failure to respond to conservative treatments
- Single level lumbar nerve root compression due to disc herniation
- Agree to participate in the research
Who cannot join
- Patients younger than 18 years and older than 65 years
- Those with non-radicular low back pain
- Those with nerve root compression due to reasons other than disc herniation
- Those with Modic type-1 changes in lumbar MRI
- Those with spinal stenosis or spondylolisthesis
- Those diagnosed with spondylodiscitis
Show all 9Show fewer
- Pregnant
- Those with inflammatory rheumatic disease
- Patients whose use of non-steroidal anti-inflammatory drugs is contraindicated (renal failure, bleeding disorders, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Steroid Injections in Lumbar Radicular Pain
Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Although there are many reasons that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernia, is one of the most common pathologies.
Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods. epidural injections; includes transforaminal, interlaminar and caudal approaches. The advantage of the transforaminal approach is that it allows access to the anterior epidural area, which is the region of pathology, and that it can spread to the target specifically around the inflamed nerve roots. The standard imaging technology used for steroid injections with this approach is fluoroscopy.
Read more
However, the aforementioned approaches carry the risk of dural puncture, epidural hematoma, epidural abscess, nerve damage, paralysis and many complications. In addition, radiation exposure is another problem. It may be possible to avoid a significant part of these risks by applying interfacial blocks used in regional anesthesia and postoperative pain control in the lumbar region. Recently, Erector Spina Plan Block (ESPB), an interfascial block technique, has been frequently applied under ultrasound (US) guidance as an alternative method to conventional paravertebral block. Investigators also frequently refer to this procedure in the clinic for patients with lumbar radicular pain.
In the literature, there are case reports of lumbar ESPB applied to patients with radicular pain due to disc herniation. Beyond case-level reports, there is no clinical study investigating the efficacy of this procedure technique for applications in the lumbar region. Starting from here, the aim of this study is; Investigators determined to compare the efficacy of erector spina plane block and transforaminal anterior epidural steroid injections in patients with radicular pain due to lumbar disc herniation.
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar
- Being tested
- Transforaminal Epidural Steroid Injection, Erector Spina Plane Block
- Keywords
- Lumbar Transforaminal Epidural Injection, Erector Spinae Plane Block
- 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.
Transforaminal Epidural Steroid InjectionProcedure or surgery
In the TFESI group, all patients were positioned prone. The injection site was cleaned with povidone-iodine 3 times and a sterile drape was applied. Short-acting local anesthesia (3 mL of 2% prilocaine) was applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle was inserted just below the pedicle. It was advanced into the subpedicular space using the coaxial technique under the intermittent guidance of fluoroscopy. The needle position was confirmed through a lateral view. Using lateral views, the needle was placed at the posterior one-third of the foramen. Using the anteroposterior view, one to 2 mL of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 8 mg (two mL) of dexamethasone, 2 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride was injected.
Erector Spina Plane BlockProcedure or surgery
Patients are placed in the prone position to determine the vertebrae in the middle of the involved area. Following the provision of aseptic conditions, the spinous process of the vertebral midline is visualized using a high-frequency (8 MHz) linear ultrasound (USG) probe. The transverse process is, then, visualized approximately at the 3 cm lateral from the midline and the erector spinae muscle is visualized on it. The 22-gauge 50 mm block needle is advanced towards the in-plane section craniocaudally and the transverse process is touched. Then the needle is then withdrawn minimally to confirm that it is between the erector spinae muscle and the transverse process through hydrodissection. Following that, 5 mL from 0.5% bupivacaine hydrochloride, 8 mg dexamethasone and 3 ml saline is administered and local anesthetic spread is confirmed by USG.
| Study group | Role | What they receive |
|---|---|---|
| Those who had lumbar radicular pain | Patients with lumbar radicular pain identified by inclusion and exclusion criteria Receives: Procedure: Transforaminal Epidural Steroid Injection; Procedure: Erector Spina Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NRS (Numeric Rating Scale)
≥50% reduction in the NRS scores at month 6 relative to the initial NRS scores.
Measured: at first hour, at three weeks, at 3 months, at 6 months
Change in ODI (Oswestry Disability Index)
≥40% reduction in ODI scores at month 6 relative to the initial ODI scores.
(ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
Measured: at first hour, at three weeks, at 3 months, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Nov 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719792
- Sponsor's protocol ID
- MU-SK-YO-17.01.23
- Status last verified
- Feb 2023
- First submitted
- 16 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010 Aug;11(8):1149-68. doi: 10.1111/j.1526-4637.2010.00908.x.
PubMed 20704666Manchikanti L, Benyamin RM, Falco FJ, Kaye AD, Hirsch JA. Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review. Clin Orthop Relat Res. 2015 Jun;473(6):1940-56. doi: 10.1007/s11999-014-3490-4.
PubMed 24515404Celik M, Tulgar S, Ahiskalioglu A, Alper F. Is high volume lumbar erector spinae plane block an alternative to transforaminal epidural injection? Evaluation with MRI. Reg Anesth Pain Med. 2019 Apr 16:rapm-2019-100514. doi: 10.1136/rapm-2019-100514. Online ahead of print. No abstract available.
PubMed 30992410
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Erector Spina Plane Block and Transforaminal Anterior Epidural Steroid Injections in Lumbar Radicular Pain
- ClinicalTrials.gov ID
- NCT05719792
- Acronym / sponsor ID
- MU-SK-YO-17.01.23
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar
- Keywords
- Lumbar Transforaminal Epidural Injection, Erector Spinae Plane Block
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 Feb 2023 (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.
Low back pain is one of the leading causes of disability and its social burden and economic cost are quite high. The lifetime prevalence in the population is frequently reported between 40% and 70%. Although there are many reasons that can lead to low back pain, radicular pain, which develops mostly secondary to lumbar disc hernia, is one of the most common pathologies.
Epidural corticosteroid and local anesthetic injections are an important treatment option in the treatment of lumbar radicular pain that does not respond to conservative methods. epidural injections; includes transforaminal, interlaminar and caudal approaches. The advantage of the transforaminal approach is that it allows access to the anterior epidural area, which is the region of pathology, and that it can spread to the target specifically around the inflamed nerve roots. The standard imaging technology used for steroid injections with this approach is fluoroscopy.
However, the aforementioned approaches carry the risk of dural puncture, epidural hematoma, epidural abscess, nerve damage, paralysis and many complications. In addition, radiation exposure is another problem. It may be possible to avoid a significant part of these risks by applying interfacial blocks used in regional anesthesia and postoperative pain control in the lumbar region. Recently, Erector Spina Plan Block (ESPB), an interfascial block technique, has been frequently applied under ultrasound (US) guidance as an alternative method to conventional paravertebral block. Investigators also frequently refer to this procedure in the clinic for patients with lumbar radicular pain.
In the literature, there are case reports of lumbar ESPB applied to patients with radicular pain due to disc herniation. Beyond case-level reports, there is no clinical study investigating the efficacy of this procedure technique for applications in the lumbar region. Starting from here, the aim of this study is; Investigators determined to compare the efficacy of erector spina plane block and transforaminal anterior epidural steroid injections in patients with radicular pain due to lumbar disc herniation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Those who had lumbar radicular pain | – | Procedure: Transforaminal Epidural Steroid Injection, Procedure: Erector Spina Plane BlockPatients with lumbar radicular pain identified by inclusion and exclusion criteria |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study group will consist of patients who are planned to receive transforaminal epidural steroid injection or erector spina plane block treatment by the clinician, and who want to participate in the study.
Key inclusion criteria (5 listed)
- Being between the ages of 18-65
- Radicular low back pain
- Failure to respond to conservative treatments
- Single level lumbar nerve root compression due to disc herniation
- Agree to participate in the research
Key exclusion criteria (9 listed)
- Patients younger than 18 years and older than 65 years
- Those with non-radicular low back pain
- Those with nerve root compression due to reasons other than disc herniation
- Those with Modic type-1 changes in lumbar MRI
- Those with spinal stenosis or spondylolisthesis
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 |
|---|---|---|
| Transforaminal Epidural Steroid InjectionIn the TFESI group, all patients were positioned prone. The injection site was cleaned with povidone-iodine 3 times and a sterile drape was applied. Short-acting local anesthesia (3 mL of 2% prilocaine) was applied to the skin and subcutaneous tissue. A 3.5-inch, 22-gauge spinal needle was inserted just below the pedicle. It was advanced into the subpedicular space using the coaxial technique under the intermittent guidance of fluoroscopy. The needle position was confirmed through a lateral view. Using lateral views, the needle was placed at the posterior one-third of the foramen. Using the anteroposterior view, one to 2 mL of the contrast agent (300 mg/50 mL iohexol) was given and the distribution pattern was visualized. Once the epidural distribution of the contrast agent was confirmed without vascular flow, a mixture of 8 mg (two mL) of dexamethasone, 2 mL of physiological saline, and 1 mL (0.5%) of bupivacaine hydrochloride was injected. | Procedure or surgery | Those who had lumbar radicular pain |
| Erector Spina Plane BlockPatients are placed in the prone position to determine the vertebrae in the middle of the involved area. Following the provision of aseptic conditions, the spinous process of the vertebral midline is visualized using a high-frequency (8 MHz) linear ultrasound (USG) probe. The transverse process is, then, visualized approximately at the 3 cm lateral from the midline and the erector spinae muscle is visualized on it. The 22-gauge 50 mm block needle is advanced towards the in-plane section craniocaudally and the transverse process is touched. Then the needle is then withdrawn minimally to confirm that it is between the erector spinae muscle and the transverse process through hydrodissection. Following that, 5 mL from 0.5% bupivacaine hydrochloride, 8 mg dexamethasone and 3 ml saline is administered and local anesthetic spread is confirmed by USG. | Procedure or surgery | Those who had lumbar radicular pain |
Primary outcome
Change in NRS (Numeric Rating Scale)
Time frame: at first hour, at three weeks, at 3 months, at 6 months
≥50% reduction in the NRS scores at month 6 relative to the initial NRS scores.
Change in ODI (Oswestry Disability Index)
Time frame: at first hour, at three weeks, at 3 months, at 6 months
≥40% reduction in ODI scores at month 6 relative to the initial ODI scores. (ODI is a deficiency/competence index that includes assessments grouped according to the types of daily activities in patients with low back pain.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Background: PubMed 20704666Ghahreman A, Ferch R, Bogduk N. The efficacy of transforaminal injection of steroids for the treatment of lumbar radicular pain. Pain Med. 2010 Aug;11(8):1149-68. doi: 10.1111/j.1526-4637.2010.00908.x.
- Background: PubMed 24515404Manchikanti L, Benyamin RM, Falco FJ, Kaye AD, Hirsch JA. Do Epidural Injections Provide Short- and Long-term Relief for Lumbar Disc Herniation? A Systematic Review. Clin Orthop Relat Res. 2015 Jun;473(6):1940-56. doi: 10.1007/s11999-014-3490-4.
- Background: PubMed 30992410Celik M, Tulgar S, Ahiskalioglu A, Alper F. Is high volume lumbar erector spinae plane block an alternative to transforaminal epidural injection? Evaluation with MRI. Reg Anesth Pain Med. 2019 Apr 16:rapm-2019-100514. doi: 10.1136/rapm-2019-100514. Online ahead of print. No abstract available.
- Individual participant dataSharing planned: No
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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. 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?
An observational study of Lumbar Disc Herniation and Radiculopathy Lumbar, run by Marmara University 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 5 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: status not confirmed, as of the sponsor's last update on 9 Feb 2023. 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?
Results are not available in the source record.
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?
Change in NRS (Numeric Rating Scale) (time frame: at first hour, at three weeks, at 3 months, at 6 months). The study lists 2 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 NCT05719792, which also lists 3 linked publications.
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 9 Feb 2023.