Radiculopathy LumbarNCT06275529
Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification
A study testing Transforaminal Epidural Steroid Injection in people with Radiculopathy Lumbar and Low Back Pain, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Radiculopathy Lumbar, Low Back Pain, Disc Herniation
- What is being tested?
- Transforaminal Epidural Steroid Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Jan 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18-65
- After outpatient evaluation, a decision was made to perform transforaminal steroid injection,
- Low back pain of more than 6 on a numeric rating scale (NRS)
- Radiculopathy for more than 4 weeks and less than one year and straight leg raising <45
- Disc herniation at the L4-L5 or L5-S1 level on MRI
- Failure to respond to medical treatment for at least one month
Who cannot join
- Neurological deficit,
- Bleeding problems,
- Localized infection,
- Spinal pathologies (such as tumors),
- Fractures,
- Severe stenosis,
Show all 13Show fewer
- Uncontrolled diabetes,
- Pregnancy,
- Red flag symptoms (such as motor and/or sphincter dysfunction)
- Patient reluctance,
- Computed tomography (CT) and MRI findings in favor of sequestrated fragments from herniated disc,
- Sphincteric disorders,
- Previous spine surgeries
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
Official title: Evaluation of Pain and Oswestry Disability Index in Different Types of Disc Herniation According to MSU Classification in Patients Undergoing Transforaminal Epidural Steroid Injection for Radicular Low Back Pain
Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.
The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.
- Being tested
- Transforaminal Epidural Steroid Injection
- Medical subject headings
- Low Back Pain, 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
Epidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections:
After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| MSU Classification 1A | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 1B | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 1C | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 2A | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 2B | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 2C | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 3A | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 3B | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 2AB | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB Receives: Procedure: Transforaminal Epidural Steroid Injection |
| MSU Classification 3AB | Experimental | Transforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB Receives: Procedure: Transforaminal Epidural Steroid Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the pain severity score
Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain).
The change in NRS scores between the ten groups will be compared.
Measured: Pre-intervention, post-intervention 1th month and post-intervention 3rd month
Change of the disability score
Disability conditions of the patients are assessed by using "Oswestry Disability Index" (ODI). ODI is a patient completed questionnaire which gives a percentage score of disability. The ODI is comprised of 10 items and enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst).
The change in ODI scores between the ten groups will be compared.
Measured: Pre-intervention, post-intervention 1th month and post-intervention 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start15 Mar 2024
- Primary completion15 Oct 2024
- Study completion15 Jan 2025
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 Radiculopathy LumbarStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Erken, Başakşehir Çam & Sakura City Hospital
- Investigators
- Tuba Tanyel Saraçoğlu, MD, Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275529
- Sponsor's protocol ID
- 27.12.2023.685
- Status last verified
- Jan 2025
- First submitted
- 17 Feb 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanyel Saracoglu T, Erken B. Impact of transforaminal epidural steroid injection on pain and disability outcomes by lumbar intervertebral disc herniation class: a prospective study. Pain Med. 2025 Aug 1;26(8):440-450. doi: 10.1093/pm/pnaf040.
PubMed 40172933
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain and Oswestry Disability Index in Different Types of Disc Herniation According to MSU Classification in Patients Undergoing Transforaminal Epidural Steroid Injection for Radicular Low Back Pain
- ClinicalTrials.gov ID
- NCT06275529
- Acronym / sponsor ID
- 27.12.2023.685
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 23 Feb 2024 (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 a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.
The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| MSU Classification 1A | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 1A |
| MSU Classification 1B | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 1B |
| MSU Classification 1C | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 1C |
| MSU Classification 2A | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 2A |
| MSU Classification 2B | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 2B |
| MSU Classification 2C | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 2C |
| MSU Classification 3A | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 3A |
| MSU Classification 3B | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 3B |
| MSU Classification 2AB | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 2AB |
| MSU Classification 3AB | Experimental | Procedure: Transforaminal Epidural Steroid InjectionTransforaminal Epidural Steroid Injection, MSU classification according to MRI images 3AB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between the ages of 18-65
- After outpatient evaluation, a decision was made to perform transforaminal steroid injection,
- Low back pain of more than 6 on a numeric rating scale (NRS)
- Radiculopathy for more than 4 weeks and less than one year and straight leg raising <45
- Disc herniation at the L4-L5 or L5-S1 level on MRI
Key exclusion criteria (13 listed)
- Neurological deficit,
- Bleeding problems,
- Localized infection,
- Spinal pathologies (such as tumors),
- Fractures,
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 InjectionEpidural injections have been used since about 1900 for the treatment of low back and lower extremity pain, with steroids added to local anesthetics in about 1950. The epidural space can be entered by 3 approaches: caudal, interlaminar, and transforaminal. Transforaminal Epidural Steroid Injections: After the patient is monitored in pron position and asepsis is ensured, the epidural space is entered with the appropriate needle through the transforaminal space by giving the necessary angles to the fluoroscopy. Then the location is confirmed with radiopaque agent and steroid injection is performed. The procedure takes 15-20 minutes. | Procedure or surgery | MSU Classification 1A, MSU Classification 1B, MSU Classification 1C, MSU Classification 2A, MSU Classification 2AB, MSU Classification 2B, MSU Classification 2C, MSU Classification 3A, MSU Classification 3AB, MSU Classification 3B |
Primary outcome
Change of the pain severity score
Time frame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month
Pain severity is assessed by using "Numeric Rating Scale" (NRS). Patients give score of their pain between 0 (no pain) and 10 (worst possible pain). The change in NRS scores between the ten groups will be compared.
Change of the disability score
Time frame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month
Disability conditions of the patients are assessed by using "Oswestry Disability Index" (ODI). ODI is a patient completed questionnaire which gives a percentage score of disability. The ODI is comprised of 10 items and enquires about functional limitations in various activities of daily living with the index score ranging from 1 (best) to 100 (worst). The change in ODI scores between the ten groups will be compared.
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 5 Mar 2025.
- Derived from this study: PubMed 40172933Tanyel Saracoglu T, Erken B. Impact of transforaminal epidural steroid injection on pain and disability outcomes by lumbar intervertebral disc herniation class: a prospective study. Pain Med. 2025 Aug 1;26(8):440-450. doi: 10.1093/pm/pnaf040.
- 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.
Tuba Tanyel Saraçoğlu, MD principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transforaminal Epidural Steroid Injection in people with Radiculopathy Lumbar and Low Back Pain, run by Başakşehir Çam & Sakura City 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 6 inclusion and 13 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 5 Mar 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?
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?
Change of the pain severity score (time frame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month). 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 NCT06275529, 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 5 Mar 2025.