TFESI and Neuropathic Pain in Lumbosacral Radiculopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMarmara University

About this trial

Patients with lumbosacral radiculopathy frequently experience neuropathic pain due to nerve root compression. Transforaminal epidural steroid injection (TFESI) is commonly used for pain relief in these patients. This study aims to evaluate the effect of TFESI on neuropathic pain severity using the Neuropathic Pain Scale (NPS) in patients with lumbosacral radiculopathy. Clinical outcomes before and after the procedure will be compared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years and older

Patients diagnosed with lumbosacral radiculopathy based on clinical evaluation and lumbar MRI findings

Presence of neuropathic pain symptoms associated with lumbosacral radiculopathy

Patients scheduled to undergo transforaminal epidural steroid injection (TFESI)

Disqualifiers

Previous lumbar spinal surgery

Cauda equina syndrome or progressive neurological deficit

Spinal malignancy, infection, or acute vertebral fracture

Pregnancy or breastfeeding

Trial design

Design model

Single group

Treatments tested in this trial

  • Transforaminal Epidural Steroid Injections

    Procedure/Surgery

    Transforaminal epidural steroid injection will be performed under fluoroscopic guidance for the treatment of lumbosacral radiculopathy.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: TFESI GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS)

hange in Neuropathic Pain Severity Assessed by the Neuropathic Pain Scale (NPS) The primary outcome measure is the change in neuropathic pain severity assessed using the Neuropathic Pain Scale (NPS) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The NPS ranges from 0 to 100, with higher scores indicating greater neuropathic pain severity (worse outcomes). Changes in NPS scores will be assessed from baseline to 3 weeks and 3 months after the intervention.

Time frame
Baseline, 3 weeks after intervention, and 3 months after intervention

Secondary outcomes

1

Change in Pain Intensity Assessed by Numeric Rating Scale (NRS)

hange in Pain Intensity Assessed by the Numeric Rating Scale (NRS) Pain intensity will be evaluated using the Numeric Rating Scale (NRS) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The NRS ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcomes). Changes in NRS scores will be assessed from baseline to 3 weeks and 3 months after the intervention.

Time frame
Baseline, 3 weeks after intervention, and 3 months after intervention
2

Change in Neuropathic Pain Symptoms Assessed by Douleur Neuropathique 4 (DN4)

Change in Neuropathic Pain Symptoms Assessed by the Douleur Neuropathique 4 (DN4) Questionnaire Neuropathic pain symptoms will be evaluated using the Douleur Neuropathique 4 (DN4) questionnaire before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The DN4 score ranges from 0 to 10, with higher scores indicating more severe neuropathic pain symptoms (worse outcomes). Changes in DN4 scores will be assessed from baseline to 3 weeks and 3 months after the intervention.

Time frame
Baseline, 3 weeks after intervention, and 3 months after intervention
3

Change in Functional Disability Assessed by Oswestry Disability Index (ODI)

Change in Functional Disability Assessed by the Oswestry Disability Index (ODI) Functional disability and limitations in daily living activities will be evaluated using the Oswestry Disability Index (ODI) before and after transforaminal epidural steroid injection (TFESI) in patients with lumbosacral radiculopathy. The ODI score ranges from 0 to 100, with higher scores indicating greater functional disability (worse outcomes). Changes in ODI scores will be assessed from baseline to 3 weeks and 3 months after the intervention.

Time frame
Baseline, 3 weeks after intervention, and 3 months after intervention
4

Association Between Contrast Dispersion Pattern and Clinical Outcomes

The change in neuropathic pain severity according to the epidural contrast dispersion pattern observed during transforaminal epidural steroid injection (TFESI) will be evaluated. The epidural contrast dispersion pattern will be classified as intraneural, extraneural, or paraneural based on fluoroscopic imaging of contrast distribution around the nerve root. Neuropathic pain severity will be assessed using the Neuropathic Pain Scale (NPS), which ranges from 0 to 100, with higher scores indicating greater neuropathic pain severity (worse outcomes). The change in NPS score from baseline will be compared among the three contrast dispersion pattern categories.

Time frame
Baseline, 3 weeks after intervention, and 3 months after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.