Lumbar Radiculopathy, Lumbosacral Radicular Pain, Straight Leg Raise
Conditions
Keywords
Straight Leg Raise Test, Lumbosacral Radicular Pain, Lumbar Radiculopathy, Diagnostic Accuracy, Transforaminal Epidural Steroid Injection, Selective Nerve Root Block
Brief 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. 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.
Interventions
None listed
Sponsors
Marmara University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Performance of the Straight Leg Raise Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity Assessed by Visual Analog Scale | Before and 1 hour after diagnostic transforaminal epidural steroid injection. | 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. |
| DN-4 Quastionnaire | Before diagnostic transforaminal epidural steroid injection | 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. |
| Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale | Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026 | 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. |
| Diagnostic Performance of the Bragard Test | Before and 1 hour after diagnostic transforaminal epidural steroid injection | 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. |
| Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging | Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026 | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTMİKDAT CAN KARABİYİK
CONTACTSERDAR KOKAR
PRINCIPAL_INVESTIGATORMİKDAT CAN KARABIYIK
Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
STUDY_DIRECTORSERDAR KOKAR
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
STUDY_DIRECTOROSMAN HAKAN GUNDUZ
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
STUDY_DIRECTORSAVAŞ ŞENCAN
Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Outcome results
None listed