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Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block

14 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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 estudo

Observacional

Inscrição (Estimado)

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: MİKDAT CAN KARABİYİK
Número de telefone: +90 537 91 92 156
E-mail: mikdatkarabiyik@gmail.com

Estude backup de contato

Nome: SERDAR KOKAR
Número de telefone: +90 541 641 51 43
E-mail: SRDRKKR@HOTMAİL.COM

Locais de estudo

Turquia (Türkiye)
- PENDİK
  - Istanbul, PENDİK, Turquia (Türkiye), 34890
    - Recrutamento
    - Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
    - Contato:
      
      SERDAR KOKAR
      
      Número de telefone: +90 541 641 51 43
      
      E-mail: SRDRKKR@HOTMAİL.COM

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Número de grupos/coortes

Coortes e Intervenções

Grupo / Coorte
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Diagnostic Performance of the Straight Leg Raise Test Prazo: 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.	Before and 1 hour after diagnostic transforaminal epidural steroid injection.

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
DN-4 Quastionnaire Prazo: 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.	Before diagnostic transforaminal epidural steroid injection
Diagnostic Performance of the Bragard Test Prazo: 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.	Before and 1 hour after diagnostic transforaminal epidural steroid injection
Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging Prazo: 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.	Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
Change in Pain Intensity Assessed by Visual Analog Scale Prazo: 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.	Before and 1 hour after diagnostic transforaminal epidural steroid injection.
Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale Prazo: 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.	Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Marmara University

Investigadores

Investigador principal: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
Diretor de estudo: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Diretor de estudo: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Diretor de estudo: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

11 de dezembro de 2025

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

15 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ