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NCT Number: NCT07400068

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mersin University Faculty of Medicine, Department of Algology

Mersin, Yenişehir, 33130, Turkey (Türkiye)

Location contact

Mesut Bakır, Assoc. Prof.

CONTACT

[email protected]

+90 545 745 06 55

About this study

This is a prospective, single-center observational study conducted at the Algology Clinic of Mersin University Faculty of Medicine. The study will include adult patients with single-level lumbar disc herniation confirmed by magnetic resonance imaging who undergo routine percutaneous laser disc decompression (PLDD) as part of standard clinical care.

According to routine clinical practice and physician decision, some patients receive adjunct transforaminal anterior epidural steroid injection with dexamethasone in the same session following PLDD using the same cannula after withdrawal from the disc space and confirmation of epidural position with contrast under fluoroscopy. This combined approach does not require an additional puncture and is part of standard clinical treatment.

Patients will be prospectively followed and divided into two groups based on routine clinical management: those undergoing PLDD alone and those undergoing PLDD with adjunct transforaminal epidural steroid injection.

Baseline demographic data including age and sex, clinical characteristics such as symptom duration and affected disc level, and comorbidities will be recorded using standardized data collection forms.

The primary outcome measure will be change in leg pain intensity assessed by the Numeric Rating Scale (NRS). Secondary outcome measures will include back pain NRS, functional status evaluated using the Oswestry Disability Index (ODI), analgesic consumption, need for additional interventions, and complication rates.

Follow-up assessments will be conducted at baseline, 2 weeks, 6 weeks, 3 months, and 6 months after the procedure through outpatient visits or telephone interviews.

All procedures included in this study are part of routine clinical practice, and no experimental interventions will be performed. Data will be collected and analyzed in accordance with ethical standards and patient confidentiality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 years and older

Diagnosis of single-level lumbar disc herniation confirmed by magnetic resonance imaging (MRI)

Presence of radicular leg pain refractory to conservative treatment

Undergoing routine percutaneous laser disc decompression (PLDD) as part of standard clinical care

Ability to provide informed consent

Exclusion criteria

Multilevel lumbar disc herniation

Extruded or sequestered disc herniation

Severe spinal canal stenosis or spinal instability

Previous lumbar spine surgery at the affected level

Active infection or systemic inflammatory disease

Coagulopathy or use of anticoagulant therapy contraindicating intervention

Pregnancy

Inability to complete follow-up assessments

Treatment and study plan

Percutaneous Laser Disc Decompression (PLDD)

Procedure

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

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

Primary outcomes

  1. Change in Leg Pain Intensity (NRS)

    Time frame: Baseline to 1 month after procedure

    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.

Secondary outcomes

  1. Change in Back Pain Intensity (NRS)

    Time frame: Baseline to 1 month after procedure

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

  2. Functional Disability (Oswestry Disability Index)

    Time frame: Baseline to 1 month after procedure

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mesut Bakır, Assoc.Prof

CONTACT

[email protected]

+905457450655

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

Effect of Adjunct Transforaminal Anterior Epidural Steroid Injection Following Percutaneous Laser Disc Decompression in Patients With Single-Level Lumbar Disc Herniation: A Prospective Observational Study

Acronym: PLDD-TFESI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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