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Идёт набор NCT07696312

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

— Наблюдательное Lumbosacral Radicular Pain Lumbar Radiculopathy Straight Leg Raise

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Lumbosacral Radicular Pain, Lumbar Radiculopathy, Straight Leg Raise. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Diagnostic Performance of the Straight Leg Raise Test [Срок оценки: Before and 1 hour after diagnostic transforaminal epidural steroid injection.]
Вторичные конечные точки (5)
  • Change in Pain Intensity Assessed by Visual Analog Scale [Срок оценки: Before and 1 hour after diagnostic transforaminal epidural steroid injection.]
  • DN-4 Quastionnaire [Срок оценки: Before diagnostic transforaminal epidural steroid injection]
  • Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale [Срок оценки: Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026]
  • Diagnostic Performance of the Bragard Test [Срок оценки: Before and 1 hour after diagnostic transforaminal epidural steroid injection]
  • Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging [Срок оценки: Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology De — Istanbul

Идентификаторы

NCT: NCT07696312 · Straight leg raise

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗