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

14 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

88

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Turkije (Türkiye)
    • PENDİK
      • Istanbul, PENDİK, Turkije (Türkiye), 34890
        • Werving
        • Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Diagnostic Performance of the Straight Leg Raise Test
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DN-4 Quastionnaire
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Marmara University

Onderzoekers

  • Hoofdonderzoeker: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
  • Studie directeur: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
  • Studie directeur: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
  • Studie directeur: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 december 2025

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

15 september 2026

Studieregistratiedata

Eerst ingediend

6 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

18 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

14 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Straight leg raise

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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