Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorMarmara University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
88 Participants
are grouped into 1 trial groupGroup A: Patients with Suspected Lumbosacral Radicular Pain
Trial outcomes
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.
Time frame
Before and 1 hour after diagnostic transforaminal epidural steroid injection.Secondary outcomes
1
Change in Pain Intensity Assessed by Visual Analog Scale
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.
Time frame
Before and 1 hour after diagnostic transforaminal epidural steroid injection.2
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.
Time frame
Before diagnostic transforaminal epidural steroid injection3
Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale
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.
Time frame
Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 20264
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.
Time frame
Before and 1 hour after diagnostic transforaminal epidural steroid injectionSponsors and contacts
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Source ClinicalTrials.gov