Femoral Stretch Test in L2-L4 Lumbar Radiculopathy
ConditionLumbar Radiculopathy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMarmara University
About this trial
This prospective observational study aims to evaluate the sensitivity of the femoral stretch test in patients with unilateral, single-root L2, L3, or L4 nerve root compression and to determine whether test positivity differs according to the affected nerve root.
Patients with unilateral radicular symptoms and magnetic resonance imaging-confirmed single-root compression involving the L2, L3, or L4 nerve root who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care will be included. The decision to perform transforaminal epidural steroid injection will be made independently of participation in the study.
Before the procedure, the femoral stretch test, pain intensity, neuropathic pain characteristics, dermatomal concordance of symptoms, and relevant magnetic resonance imaging findings will be recorded. The femoral stretch test and pain intensity will be reassessed 1 hour after the procedure. The study will primarily evaluate the sensitivity of the femoral stretch test for L2, L3, and L4 nerve root involvement and will also assess changes in test findings following transforaminal epidural steroid injection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a diagnosis of lumbar radicular pain based on medical history, physical examination, and imaging findings.
Patients with unilateral L2, L3, or L4 nerve root involvement who are scheduled to undergo single-level, unilateral transforaminal epidural steroid injection targeting the corresponding nerve root.
Disqualifiers
Presence of diabetes mellitus or other medical conditions that may cause polyneuropathy.
Presence of active radicular pain originating from lumbosacral nerve roots other than L2, L3, or L4.
Unavailability of relevant radiological imaging.
Cognitive impairment that may interfere with clinical assessment.
Trial population
Adult patients with lumbar radicular pain who are evaluated at a tertiary pain medicine clinic and are scheduled to undergo clinically indicated single-level, unilateral transforaminal epidural steroid injection targeting the L2, L3, or L4 nerve root will be prospectively enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 3 trial groupsGroup A: L2 Nerve Root Compression Cohort
Group B: L3 Nerve Root Compression Cohort
Group C: L4 Nerve Root Compression Cohort
Trial outcomes
Primary outcomes
1
Root-Level Sensitivity of the Femoral Stretch Test for L2, L3, and L4 Nerve Root Compression
The sensitivity of the femoral stretch test will be calculated separately in patients with unilateral, Magnetic Resonance Imaging-confirmed single-root L2, L3, and L4 nerve root compression. Root-level sensitivities will be compared to determine whether the diagnostic sensitivity of the test differs according to the affected nerve root.
Time frame
BaselineSecondary outcomes
1
Change in Femoral Stretch Test Positivity Following Transforaminal Epidural Steroid Injection
Femoral stretch test results will be recorded as positive or negative immediately before and after transforaminal epidural steroid injection. The proportion of patients with a change from a positive to a negative test following the procedure will be evaluated overall and according to the affected nerve root (L2, L3, and L4).
Time frame
Baseline and 1 hour post-procedure2
Change in Pain Intensity Following Transforaminal Epidural Steroid Injection
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain), immediately before and after transforaminal epidural steroid injection. The change in Numeric Rating Scale score following the procedure will be evaluated.
Time frame
Baseline and 1 hour post-procedure3
Association Between Femoral Stretch Test Positivity and Magnetic Resonance Imaging Nerve Root Compression Severity
The association between pre-procedural femoral stretch test positivity and the severity of nerve root compression on lumbar magnetic resonance imaging will be evaluated in patients with unilateral, single-root L2, L3, or L4 nerve root compression.
Time frame
Baseline4
Association Between Femoral Stretch Test Positivity and Neuropathic Pain Characteristics
Neuropathic pain characteristics will be assessed using the 10-item DN4 neuropathic pain questionnaire, a validated screening tool for neuropathic pain. The total score ranges from 0 to 10, with higher scores indicating a greater likelihood of neuropathic pain. The association between the pre-procedural DN4 score and femoral stretch test positivity will be evaluated in patients with unilateral, single-root L2, L3, or L4 nerve root compression.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov