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

2026. augusztus 14. frissítette: 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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Név: MİKDAT CAN KARABİYİK
Telefonszám: +90 537 91 92 156
E-mail: mikdatkarabiyik@gmail.com

Tanulmányozza a kapcsolattartók biztonsági mentését

Név: SERDAR KOKAR
Telefonszám: +90 541 641 51 43
E-mail: SRDRKKR@HOTMAİL.COM

Tanulmányi helyek

Törökország (Türkiye)
- PENDİK
  - Istanbul, PENDİK, Törökország (Türkiye), 34890
    - Toborzás
    - Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
    - Kapcsolatba lépni:
      
      SERDAR KOKAR
      
      Telefonszám: +90 541 641 51 43
      
      E-mail: SRDRKKR@HOTMAİL.COM

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

Felnőtt
Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

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.

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Diagnostic Performance of the Straight Leg Raise Test Időkeret: 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.

Másodlagos eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
DN-4 Quastionnaire Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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 Időkeret: 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

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Marmara University

Nyomozók

Kutatásvezető: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
Tanulmányi igazgató: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Tanulmányi igazgató: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Tanulmányi igazgató: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2025. december 11.

Elsődleges befejezés (Becsült)

2026. szeptember 1.

A tanulmány befejezése (Becsült)

2026. szeptember 15.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. július 6.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak