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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07400068
Acronym
PLDD-TFESI
Enrollment
88
Registered
2026-02-10
Start date
2026-03-01
Completion date
2027-09-01
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Herniation, Lumbar Radiculopathy

Keywords

Percutaneous Laser Disc Decompression, Transforaminal Epidural Steroid Injection, Minimally Invasive Spine Treatment, Radicular Pain, PLDD

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREPercutaneous Laser Disc Decompression (PLDD)

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

PROCEDURETransforaminal Anterior Epidural Steroid Injection

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

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Leg Pain Intensity (NRS)Baseline to 1 month after procedureChange 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

MeasureTime frameDescription
Change in Back Pain Intensity (NRS)Baseline to 1 month after procedureChange in low back pain intensity assessed using the Numeric Rating Scale (NRS, 0-10).
Functional Disability (Oswestry Disability Index)Baseline to 1 month after procedureFunctional status assessed using the Oswestry Disability Index (ODI), a validated questionnaire measuring disability related to low back pain.

Countries

Turkey (Türkiye)

Contacts

CONTACTMesut Bakır, Assoc.Prof
mesutbakir@gmail.com+905457450655
PRINCIPAL_INVESTIGATORMesut Bakır

Mersin University Faculty of Medicine, Pain Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026