Lumbar RadiculopathyNCT07799142
Femoral Stretch Test in L2-L4 Lumbar Radiculopathy
An observational study of Lumbar Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Lumbar Radiculopathy
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Sep 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
- Pregnancy.
- Presence of local or systemic infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Pendik Training and Research Hospital
Istanbul, Pendik, 34899
Nurbanu Hindioglu Dogan, MD, +902166254545, nurbanuhindioglu@gmail.com
About this study
Official title: Root-Level Diagnostic Sensitivity of the Femoral Stretch Test in Patients With L2, L3, or L4 Nerve Root Compression: A Prospective Observational Study
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.
- Conditions
- Lumbar Radiculopathy
- Keywords
- transforaminal epidural injection, femoral strecth test
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| L2 Nerve Root Compression Cohort | Patients with unilateral, magnetic resonance imaging-confirmed single-root L2 nerve root compression and clinically concordant radicular symptoms who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care. Femoral stretch test findings and pain intensity will be recorded before and after the procedure. | |
| L3 Nerve Root Compression Cohort | Patients with unilateral, magnetic resonance imaging-confirmed single-root L3 nerve root compression and clinically concordant radicular symptoms who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care. Femoral stretch test findings and pain intensity will be recorded before and after the procedure. | |
| L4 Nerve Root Compression Cohort | Patients with unilateral, magnetic resonance imaging-confirmed single-root L4 nerve root compression and clinically concordant radicular symptoms who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care. Femoral stretch test findings and pain intensity will be recorded before and after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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).
Measured: Baseline and 1 hour post-procedure
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.
Measured: Baseline and 1 hour post-procedure
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start7 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurbanu Hindioglu Dogan, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799142
- Sponsor's protocol ID
- 09.2025.408
- Status last verified
- Sep 2026
- First submitted
- 26 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Root-Level Diagnostic Sensitivity of the Femoral Stretch Test in Patients With L2, L3, or L4 Nerve Root Compression: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07799142
- Acronym / sponsor ID
- 09.2025.408
- Conditions
- Lumbar Radiculopathy
- Keywords
- transforaminal epidural injection, femoral strecth test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L2 Nerve Root Compression Cohort | – | –Patients with unilateral, magnetic resonance imaging-confirmed single-root L2 nerve root compression and clinically concordant radicular symptoms who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care. Femoral stretch test findings and pain intensity will be recorded before and after the procedure. |
| L3 Nerve Root Compression Cohort | – | –Patients with unilateral, magnetic resonance imaging-confirmed single-root L3 nerve root compression and clinically concordant radicular symptoms who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care. Femoral stretch test findings and pain intensity will be recorded before and after the procedure. |
| L4 Nerve Root Compression Cohort | – | –Patients with unilateral, magnetic resonance imaging-confirmed single-root L4 nerve root compression and clinically concordant radicular symptoms who are scheduled to undergo transforaminal epidural steroid injection as part of routine clinical care. Femoral stretch test findings and pain intensity will be recorded before and after the procedure. |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Root-Level Sensitivity of the Femoral Stretch Test for L2, L3, and L4 Nerve Root Compression
Time frame: Baseline
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.
4 secondary outcomes
Change in Femoral Stretch Test Positivity Following Transforaminal Epidural Steroid Injection
Time frame: Baseline and 1 hour post-procedure
Change in Pain Intensity Following Transforaminal Epidural Steroid Injection
Time frame: Baseline and 1 hour post-procedure
Association Between Femoral Stretch Test Positivity and Magnetic Resonance Imaging Nerve Root Compression Severity
Time frame: Baseline
Association Between Femoral Stretch Test Positivity and Neuropathic Pain Characteristics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Radiculopathy, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nurbanu Hindioglu Dogan, MD (+902166254545, nurbanuhindioglu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root-Level Sensitivity of the Femoral Stretch Test for L2, L3, and L4 Nerve Root Compression (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.