NCT07696312 "Determination of Sensitivity and Specificity of Straight Leg Raise Test Via Transforaminal Nerve Root Block
| NCT ID | NCT07696312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Marmara University |
| Condition | Lumbosacral Radicular Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2025-12-11 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 88 participants in total. It began in 2025-12-11 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
MİKDAT CAN KARABIYIK
PRINCIPAL INVESTIGATOR
Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation
Frequently Asked Questions
Who can join the NCT07696312 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lumbosacral Radicular Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07696312 currently recruiting?
Yes, NCT07696312 is actively recruiting participants. Contact the research team at mikdatkarabiyik@gmail.com for enrollment information.
Where is the NCT07696312 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07696312 clinical trial?
NCT07696312 is sponsored by Marmara University. The principal investigator is MİKDAT CAN KARABIYIK at Marmara University Faculty of Medicine ,Marmara University, Department of Physical Medicine and Rehabilitation. The trial plans to enroll 88 participants.