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

NCT07696312 | Recruiting

• 1 other identifier: Straight leg raise
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Straight Leg Raise; Lumbosacral Radicular Pain; Lumbar Radiculopathy

Keywords

Straight Leg Raise Test; Lumbosacral Radicular Pain; Lumbar Radiculopathy; Diagnostic Accuracy; Transforaminal Epidural Steroid Injection; Selective Nerve Root Block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Pain Intensity Assessed by Visual Analog Scale

  Before and 1 hour after diagnostic transforaminal epidural steroid injection.

• DN-4 Quastionnaire

  Before diagnostic transforaminal epidural steroid injection

• Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale

  Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026

• Diagnostic Performance of the Bragard Test

  Before and 1 hour after diagnostic transforaminal epidural steroid injection

• Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging

  Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting

Istanbul, PENDİK, 34890, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• MİKDAT CAN KARABIYIK

  Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

MİKDAT CAN KARABİYİK

CONTACT

+90 537 91 92 156; mikdatkarabiyik@gmail.com

SERDAR KOKAR

CONTACT

+90 541 641 51 43; srdrkkr@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)