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PLDD With or Without Transforaminal Epidural Steroid Injection in Lumbar Disc Herniation

ConditionsLumbar Disc HerniationLumbar Radiculopathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMersin University

About this trial

This prospective observational study aims to evaluate the clinical outcomes of patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD).

In routine clinical practice, some patients receive an additional transforaminal anterior epidural steroid injection during the same session without an extra puncture. This study will prospectively follow patients who receive PLDD alone and those who receive PLDD combined with epidural steroid injection.

Pain intensity, functional status, analgesic use, need for additional interventions, and complications will be assessed over time. The results may help to clarify whether adding epidural steroid injection to PLDD improves clinical outcomes in patients with lumbar disc herniation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Adult patients aged 18 years and older with single-level lumbar disc herniation confirmed by magnetic resonance imaging who undergo routine percutaneous laser disc decompression at a tertiary university algology clinic will be included. Patients may receive PLDD alone or PLDD combined with adjunct transforaminal anterior epidural steroid injection according to routine clinical practice.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous Laser Disc Decompression (PLDD)

    Procedure/Surgery

    Routine minimally invasive laser-based disc decompression performed under fluoroscopic guidance to reduce intradiscal pressure in patients with lumbar disc herniation.

  • Transforaminal Anterior Epidural Steroid Injection

    Procedure/Surgery

    Routine transforaminal anterior epidural injection of dexamethasone performed under fluoroscopic guidance following PLDD during the same session without additional puncture.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: PLDD Alone1 intervention
Group B: PLDD Plus Transforaminal Epidural Steroid Injection1 intervention

Trial outcomes

Primary outcomes

1

Change in Leg Pain Intensity (NRS)

Change in leg pain intensity assessed using the Numeric Rating Scale (NRS, 0-10), where 0 indicates no pain and 10 indicates worst possible pain.

Time frame
Baseline to 1 month after procedure

Secondary outcomes

1

Change in Back Pain Intensity (NRS)

Change in low back pain intensity assessed using the Numeric Rating Scale (NRS, 0-10).

Time frame
Baseline to 1 month after procedure
2

Functional Disability (Oswestry Disability Index)

Functional status assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring disability related to low back pain.

Time frame
Baseline to 1 month after procedure

Other outcomes

Sponsors and contacts

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

Mersin University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: