Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
2026년 8월 14일 업데이트: Marmara University
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.
연구 개요
상태
상태
모병
정황
정황
상세 설명
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.
연구 유형
연구 유형
관찰
등록 (추정된)
등록
88
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: MİKDAT CAN KARABİYİK
- 전화번호: +90 537 91 92 156
- 이메일: mikdatkarabiyik@gmail.com
연구 연락처 백업
- 이름: SERDAR KOKAR
- 전화번호: +90 541 641 51 43
- 이메일: SRDRKKR@HOTMAİL.COM
연구 장소
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PENDİK
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Istanbul, PENDİK, 터키 (Türkiye), 34890
- 모병
- Marmara University Faculty of Medicine, Pendik Training and Research Hospital, Algology Department Recruiting
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연락하다:
- SERDAR KOKAR
- 전화번호: +90 541 641 51 43
- 이메일: SRDRKKR@HOTMAİL.COM
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
1
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Diagnostic Performance of the Straight Leg Raise Test
기간: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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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.
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Before and 1 hour after diagnostic transforaminal epidural steroid injection.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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DN-4 Quastionnaire
기간: Before diagnostic transforaminal epidural steroid injection
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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.
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Before diagnostic transforaminal epidural steroid injection
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Diagnostic Performance of the Bragard Test
기간: Before and 1 hour after diagnostic transforaminal epidural steroid injection
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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.
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Before and 1 hour after diagnostic transforaminal epidural steroid injection
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Nerve Root Compression Grade on Lumbar Magnetic Resonance Imaging
기간: Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
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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.
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Using available lumbar magnetic resonance imaging during the study period, up to November 1, 2026
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Change in Pain Intensity Assessed by Visual Analog Scale
기간: Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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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.
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Before and 1 hour after diagnostic transforaminal epidural steroid injection.
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Intervertebral Disc Degeneration Assessed by Pfirrmann Grading Scale
기간: Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026
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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.
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Using available lumbar magnetic resonance imaging obtained before or after the diagnostic intervention, up to November 1, 2026
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: MİKDAT CAN KARABIYIK, Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
- 연구 책임자: SERDAR KOKAR, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- 연구 책임자: OSMAN HAKAN GUNDUZ, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
- 연구 책임자: SAVAŞ ŞENCAN, Algology Division, Department of Physical Medicine and Rehabilitation, Marmara University Faculty of Medicine
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
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이 연구와 관련된 용어
키워드
기타 연구 ID 번호
기타 연구 ID 번호
- Straight leg raise
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아니요
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