Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
14 de agosto de 2026 actualizado por: Marmara University
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.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
88
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: MİKDAT CAN KARABİYİK
- Número de teléfono: +90 537 91 92 156
- Correo electrónico: mikdatkarabiyik@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: SERDAR KOKAR
- Número de teléfono: +90 541 641 51 43
- Correo electrónico: SRDRKKR@HOTMAİL.COM
Ubicaciones de estudio
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PENDİK
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Istanbul, PENDİK, Turquía (Türkiye), 34890
- Reclutamiento
- Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
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Contacto:
- SERDAR KOKAR
- Número de teléfono: +90 541 641 51 43
- Correo electrónico: SRDRKKR@HOTMAİL.COM
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic Performance of the Straight Leg Raise Test
Periodo de tiempo: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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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.
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Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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DN-4 Quastionnaire
Periodo de tiempo: Before diagnostic transforaminal epidural steroid injection
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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.
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Before diagnostic transforaminal epidural steroid injection
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Diagnostic Performance of the Bragard Test
Periodo de tiempo: Before and 1 hour after diagnostic transforaminal epidural steroid injection
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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.
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Before and 1 hour after diagnostic transforaminal epidural steroid injection
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Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging
Periodo de tiempo: Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
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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.
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Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
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Change in Pain Intensity Assessed by Visual Analog Scale
Periodo de tiempo: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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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.
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Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale
Periodo de tiempo: Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026
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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.
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Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
- Director de estudio: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- Director de estudio: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- Director de estudio: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
11 de diciembre de 2025
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
15 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
6 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Straight leg raise
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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