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.
Studieoversikt
Status
Detaljert beskrivelse
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
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: MİKDAT CAN KARABİYİK
- Telefonnummer: +90 537 91 92 156
- E-post: mikdatkarabiyik@gmail.com
Studer Kontakt Backup
- Navn: SERDAR KOKAR
- Telefonnummer: +90 541 641 51 43
- E-post: SRDRKKR@HOTMAİL.COM
Studiesteder
-
-
PENDİK
-
Istanbul, PENDİK, Tyrkia (Türkiye), 34890
- Rekruttering
- Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
-
Ta kontakt med:
- SERDAR KOKAR
- Telefonnummer: +90 541 641 51 43
- E-post: SRDRKKR@HOTMAİL.COM
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnostic Performance of the Straight Leg Raise Test
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
DN-4 Quastionnaire
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
- Studieleder: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- Studieleder: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- Studieleder: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Straight leg raise
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .