"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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Radiculopathy; Lumbosacral Radicular Pain; Straight Leg Raise

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 88

Contacts and Locations

• Study Contact: Name: MİKDAT CAN KARABİYİK; Phone Number: +90 537 91 92 156; Email: mikdatkarabiyik@gmail.com
• Study Contact Backup: Name: SERDAR KOKAR; Phone Number: +90 541 641 51 43; Email: SRDRKKR@HOTMAİL.COM

Study Locations

• Turkey (Türkiye)
  • PENDİK
    • Istanbul, PENDİK, Turkey (Türkiye), 34890
      • Recruiting
      • Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
      • Contact: SERDAR KOKAR; Phone Number: +90 541 641 51 43; Email: SRDRKKR@HOTMAİL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Performance of the Straight Leg Raise Test	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Assessed by Visual Analog Scale	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	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	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	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	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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation; Study Director: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine; Study Director: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine; Study Director: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Lumbar Radiculopathy; Diagnostic Accuracy; Transforaminal Epidural Steroid Injection; Lumbosacral Radicular Pain; Straight Leg Raise Test; Selective Nerve Root Block
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: Straight leg raise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No