NCT07799142

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

August 26, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

September 7, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

August 26, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

transforaminal epidural injectionfemoral strecth test

Outcome Measures

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.

    Baseline

Secondary Outcomes (4)

  • Change in Femoral Stretch Test Positivity Following Transforaminal Epidural Steroid Injection

    Baseline and 1 hour post-procedure

  • Change in Pain Intensity Following Transforaminal Epidural Steroid Injection

    Baseline and 1 hour post-procedure

  • Association Between Femoral Stretch Test Positivity and Magnetic Resonance Imaging Nerve Root Compression Severity

    Baseline

  • Association Between Femoral Stretch Test Positivity and Neuropathic Pain Characteristics

    Baseline

Study Arms (3)

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.

Eligibility Criteria

Age18 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Central Study Contacts

Nurbanu Hindioglu Dogan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2026

First Posted

September 2, 2026

Study Start

September 7, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared publicly due to participant confidentiality and data protection considerations.

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