"Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: MİKDAT CAN KARABİYİK
- Numero di telefono: +90 537 91 92 156
- Email: mikdatkarabiyik@gmail.com
Backup dei contatti dello studio
- Nome: SERDAR KOKAR
- Numero di telefono: +90 541 641 51 43
- Email: SRDRKKR@HOTMAİL.COM
Luoghi di studio
-
-
PENDİK
-
Istanbul, PENDİK, Turchia (Türkiye), 34890
- Reclutamento
- Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
-
Contatto:
- SERDAR KOKAR
- Numero di telefono: +90 541 641 51 43
- Email: SRDRKKR@HOTMAİL.COM
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Diagnostic Performance of the Straight Leg Raise Test
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Pain Intensity Assessed by Visual Analog Scale
Lasso di tempo: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
|
Pain intensity will be assessed using the Visual Analog Scale 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.
|
|
DN-4 Quastionnaire
Lasso di tempo: 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
|
|
Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale
Lasso di tempo: 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.
Pfirrmann grades will be assessed 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
|
|
Diagnostic Performance of the Bragard Test
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
- Direttore dello studio: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- Direttore dello studio: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- Direttore dello studio: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Straight leg raise
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .