Lumbosacral Radicular PainNCT07696312
Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
An observational study of Lumbosacral Radicular Pain and Lumbar Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the diagnostic accuracy of the straight leg raise test in patients with suspected lumbosacral radicular pain. Lumbosacral radicular pain is often caused by lumbar disc herniation and may radiate from the lower back or buttock to the leg. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbosacral Radicular Pain, Lumbar Radiculopathy, Straight Leg Raise
- Type of treatment
- Injection or infusion
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Dec 2025to 15 Sep 2026
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 to 65 years with a preliminary diagnosis of lumbar radicular pain based on medical history, physical examination, and lumbar magnetic resonance imaging, who are scheduled to undergo transforaminal epidural injection targeting the L4, L5, or S1 nerve root, will be included in the study.
Who may be able to join
- Age between 18 and 65 years.
- Preliminary diagnosis of lumbar radicular pain based on medical history, physical examination, and lumbar magnetic resonance imaging.
- Patients scheduled to undergo transforaminal epidural injection targeting the L4, L5, or S1 nerve root.
Who cannot join
- Inability to access clinical or procedural records in the hospital system.
- Absence of available radiological records related to the target level, if required.
- Inability to provide reliable NRS or straight leg raise test assessment due to cognitive impairment or language barrier.
- Coagulopathy, defined as INR > 1.5 or platelet count < 80,000/mm³, or inability to discontinue anticoagulant or antiplatelet therapy when required.
- Local or systemic infection, or skin lesion at the planned injection site.
- Pregnancy or breastfeeding.
Show all 13Show fewer
- Known severe hypersensitivity to iodinated contrast material or local anesthetics.
- Progressive neurological deficit or cauda equina syndrome.
- Bilateral or nearly bilateral pain with both sides being prominent and equivalent, or need for therapeutic injection at more than one level during the same session.
- Epidural injection with local anesthetic and/or steroid at the same level within the last 6 weeks.
- Active polyneuropathy or other diffuse neuropathies.
- Active radicular pain originating from nerve roots other than L4, L5, or S1.
- Requirement for mandatory sedation.
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
Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
Istanbul, PENDİK, 34890
SERDAR KOKAR, +90 541 641 51 43, SRDRKKR@HOTMAİL.COM
About this study
This study aims to evaluate the diagnostic accuracy of the straight leg raise test in patients with suspected lumbosacral radicular pain. Lumbosacral radicular pain is often caused by lumbar disc herniation and may radiate from the lower back or buttock to the leg. Although the straight leg raise test is commonly used in clinical practice, its diagnostic performance has been reported to vary.
In this study, diagnostic transforaminal epidural steroid injection or selective nerve root block will be used as the reference standard. The sensitivity, specificity, likelihood ratios, and area under the curve of the straight leg raise test will be calculated. The findings may help guide clinicians in determining when the straight leg raise test is sufficient and when further diagnostic confirmation may be needed.
Read the detailed description
Low back pain is one of the leading causes of disability worldwide. Lumbosacral radicular pain is commonly caused by lumbar disc herniation and is characterized by pain radiating from the lower back or buttock to the leg in a dermatomal distribution. The straight leg raise test is a simple and widely used physical examination test for evaluating suspected lumbar radiculopathy; however, its diagnostic accuracy varies across studies.
This study aims to evaluate the diagnostic performance of the straight leg raise test in patients with suspected lumbosacral radicular pain. Diagnostic transforaminal epidural steroid injection or selective nerve root block will be used as the reference standard. Only technically selective injections performed without sedation and with a low volume of short-acting local anesthetic will be included in the analysis. The study will assess the sensitivity, specificity, likelihood ratios, and area under the curve of the straight leg raise test. The results may help clarify when the straight leg raise test is reliable on its own and when additional diagnostic confirmation may be needed for clinical decision-making.
- Keywords
- Straight Leg Raise Test, Lumbosacral Radicular Pain, Lumbar Radiculopathy, Diagnostic Accuracy, Transforaminal Epidural Steroid Injection, Selective Nerve Root Block
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Suspected Lumbosacral Radicular Pain | Patients with suspected lumbosacral radicular pain who undergo clinical evaluation including the straight leg raise test and diagnostic transforaminal epidural steroid injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance of the Straight Leg Raise Test
The diagnostic performance of the straight leg raise test will be evaluated in patients with suspected lumbosacral radicular pain using diagnostic transforaminal epidural steroid injection as the reference standard.
Measured: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
Secondary outcomes (5)
Change in Pain Intensity Assessed by Visual Analog Scale
Pain intensity will be assessed using the Visual Analog Scale, which ranges from 0 to 10, with higher scores indicating greater pain intensity. Pain intensity will be measured before and 1 hour after diagnostic transforaminal epidural steroid injection. The change in Visual Analog Scale score after the diagnostic intervention will be evaluated in patients with suspected lumbosacral radicular pain.
Measured: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
DN-4 Quastionnaire
The DN-4 (Douleur Neuropathique en 4 Questions) is a brief and reliable screening questionnaire used to determine whether a patient's pain is of neuropathic origin. It consists of a total of 10 items. Its name, DN-4, derives from the fact that it includes 4 main sections. Seven of the questions relate to patient-reported sensory symptoms, while three are based on clinical examination findings. Each "yes" response scores 1 point, yielding a total score ranging from 0 to 10. A score above 4 indicates a high likelihood of neuropathic pain.
Measured: Before diagnostic transforaminal epidural steroid injection
Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale
Intervertebral disc degeneration will be evaluated using the Pfirrmann grading scale on lumbar magnetic resonance imaging. The Pfirrmann grading scale ranges from grade I to grade V, with higher grades indicating more severe intervertebral disc degeneration. Pfirrmann grades will be evaluated in relation to clinical findings, straight leg raise test results, pain intensity, and response to the diagnostic intervention in patients with suspected lumbosacral radicular pain.
Measured: Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026
Diagnostic Performance of the Bragard Test
The diagnostic performance of the Bragard test will be evaluated in patients with suspected lumbosacral radicular pain. The Bragard test will be assessed before and 1 hour after diagnostic transforaminal epidural steroid injection, using the response to the diagnostic intervention as the reference standard.
Measured: Before and 1 hour after diagnostic transforaminal epidural steroid injection
Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging
The degree of nerve root compression will be evaluated on lumbar magnetic resonance imaging in patients with suspected lumbosacral radicular pain. Nerve root compression grade will be assessed in relation to straight leg raise test results, Bragard test results, pain intensity, and response to diagnostic transforaminal epidural steroid injection.
Measured: Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start11 Dec 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral Radicular PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MİKDAT CAN KARABIYIK, Principal investigator, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and RehabilitationSERDAR KOKAR, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of MedicineOSMAN HAKAN GUNDUZ, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of MedicineSAVAŞ ŞENCAN, Study director, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696312
- Sponsor's protocol ID
- Straight leg raise
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
- ClinicalTrials.gov ID
- NCT07696312
- Acronym / sponsor ID
- Straight leg raise
- Keywords
- Straight Leg Raise Test, Lumbosacral Radicular Pain, Lumbar Radiculopathy, Diagnostic Accuracy, Transforaminal Epidural Steroid Injection, Selective Nerve Root Block
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 10 Jul 2026 (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 evaluate the diagnostic accuracy of the straight leg raise test in patients with suspected lumbosacral radicular pain. Lumbosacral radicular pain is often caused by lumbar disc herniation and may radiate from the lower back or buttock to the leg. Although the straight leg raise test is commonly used in clinical practice, its diagnostic performance has been reported to vary.
In this study, diagnostic transforaminal epidural steroid injection or selective nerve root block will be used as the reference standard. The sensitivity, specificity, likelihood ratios, and area under the curve of the straight leg raise test will be calculated. The findings may help guide clinicians in determining when the straight leg raise test is sufficient and when further diagnostic confirmation may be needed.
Detailed description
Low back pain is one of the leading causes of disability worldwide. Lumbosacral radicular pain is commonly caused by lumbar disc herniation and is characterized by pain radiating from the lower back or buttock to the leg in a dermatomal distribution. The straight leg raise test is a simple and widely used physical examination test for evaluating suspected lumbar radiculopathy; however, its diagnostic accuracy varies across studies.
This study aims to evaluate the diagnostic performance of the straight leg raise test in patients with suspected lumbosacral radicular pain. Diagnostic transforaminal epidural steroid injection or selective nerve root block will be used as the reference standard. Only technically selective injections performed without sedation and with a low volume of short-acting local anesthetic will be included in the analysis. The study will assess the sensitivity, specificity, likelihood ratios, and area under the curve of the straight leg raise test. The results may help clarify when the straight leg raise test is reliable on its own and when additional diagnostic confirmation may be needed for clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Suspected Lumbosacral Radicular Pain | – | –Patients with suspected lumbosacral radicular pain who undergo clinical evaluation including the straight leg raise test and diagnostic transforaminal epidural steroid injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 to 65 years with a preliminary diagnosis of lumbar radicular pain based on medical history, physical examination, and lumbar magnetic resonance imaging, who are scheduled to undergo transforaminal epidural injection targeting the L4, L5, or S1 nerve root, will be included in the study.
Key inclusion criteria (3 listed)
- Age between 18 and 65 years.
- Preliminary diagnosis of lumbar radicular pain based on medical history, physical examination, and lumbar magnetic resonance imaging.
- Patients scheduled to undergo transforaminal epidural injection targeting the L4, L5, or S1 nerve root.
Key exclusion criteria (13 listed)
- Inability to access clinical or procedural records in the hospital system.
- Absence of available radiological records related to the target level, if required.
- Inability to provide reliable NRS or straight leg raise test assessment due to cognitive impairment or language barrier.
- Coagulopathy, defined as INR > 1.5 or platelet count < 80,000/mm³, or inability to discontinue anticoagulant or antiplatelet therapy when required.
- Local or systemic infection, or skin lesion at the planned injection site.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic Performance of the Straight Leg Raise Test
Time frame: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
The diagnostic performance of the straight leg raise test will be evaluated in patients with suspected lumbosacral radicular pain using diagnostic transforaminal epidural steroid injection as the reference standard.
5 secondary outcomes
Change in Pain Intensity Assessed by Visual Analog Scale
Time frame: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
DN-4 Quastionnaire
Time frame: Before diagnostic transforaminal epidural steroid injection
Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale
Time frame: Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026
Diagnostic Performance of the Bragard Test
Time frame: Before and 1 hour after diagnostic transforaminal epidural steroid injection
Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging
Time frame: Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
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 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Lumbosacral Radicular Pain
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Not yet recruitingPhase 4
Comparing Three Epidural Steroid Injection Approaches for Lumbar Radicular Pain
Lumbar Disc Herniation, Lumbosacral Radiculopathy
Not yet recruitingPhase 3
Corticosteroid Lumbar Epidural Analgesia for Radicular Pain 2
Lumbosacral Radicular Pain
Recruiting
TFESI and Neuropathic Pain in Lumbosacral Radiculopathy
Lumbosacral Radiculopathy, Neuropathic Pain From Lumbosacral Radiculopathy
RecruitingObservational study
Three CT Signs of Nerve-root Suffering in Low-back Sciatica: a Study of Their Frequency in Patients Referred for CT-guided Nerve-root Infiltration.
Sciatica, Lumbosacral Radiculopathy
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.
MİKDAT CAN KARABIYIK principal investigator
Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
SERDAR KOKAR study director
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
OSMAN HAKAN GUNDUZ study director
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
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 Lumbosacral Radicular Pain and Lumbar Radiculopathy, 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 3 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. 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 MİKDAT CAN KARABİYİK (+90 537 91 92 156, mikdatkarabiyik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Performance of the Straight Leg Raise Test (time frame: Before and 1 hour after diagnostic transforaminal epidural steroid injection.). 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 18 Aug 2026.