PLDD With or Without Transforaminal Epidural Steroid Injection in Lumbar Disc Herniation (PLDD-TFESI)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Disc Herniation; Lumbar Radiculopathy
• Intervention / Treatment: Procedure: Percutaneous Laser Disc Decompression (PLDD); Procedure: Transforaminal Anterior Epidural Steroid Injection

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.

• Study Type: Observational
• Enrollment (Estimated): 88

Contacts and Locations

• Study Contact: Name: Mesut Bakır, Assoc.Prof; Phone Number: +905457450655; Email: mesutbakir@gmail.com

Study Locations

• Turkey (Türkiye)
  • Yenişehir
    • Mersin, Yenişehir, Turkey (Türkiye), 33130
      • Mersin University Faculty of Medicine, Department of Algology
      • Contact: Mesut Bakır, Assoc. Prof.; Phone Number: +90 545 745 06 55; Email: mesutbakir@mersin.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PLDD Alone; Patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD) as part of standard clinical care without adjunct epidural steroid injection.	Procedure: Percutaneous 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.
PLDD Plus Transforaminal Epidural Steroid Injection; Patients with single-level lumbar disc herniation who undergo routine percutaneous laser disc decompression (PLDD) followed by adjunct transforaminal anterior epidural steroid injection with dexamethasone during the same session as part of standard clinical care.	Procedure: Transforaminal Anterior Epidural Steroid Injection; Routine transforaminal anterior epidural injection of dexamethasone performed under fluoroscopic guidance following PLDD during the same session without additional puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 1 month after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Principal Investigator: Mesut Bakır, Mersin University Faculty of Medicine, Pain Clinic

Publications and helpful links

General Publications

• Benyamin RM, Manchikanti L, Parr AT, Diwan S, Singh V, Falco FJ, Datta S, Abdi S, Hirsch JA. The effectiveness of lumbar interlaminar epidural injections in managing chronic low back and lower extremity pain. Pain Physician. 2012 Jul-Aug;15(4):E363-404.
• Foresti ML, Ferreira ML. Lipase-catalyzed acidolysis of tripalmitin with capric acid in organic solvent medium: Analysis of the effect of experimental conditions through factorial design and analysis of multiple responses. Enzyme Microb Technol. 2010 May 5;46(6):419-29. doi: 10.1016/j.enzmictec.2010.01.002. Epub 2010 Jan 21.
• Giger JM, Haddad F, Qin AX, Zeng M, Baldwin KM. Effect of unloading on type I myosin heavy chain gene regulation in rat soleus muscle. J Appl Physiol (1985). 2005 Apr;98(4):1185-94. doi: 10.1152/japplphysiol.01099.2004. Epub 2004 Dec 10.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Radicular Pain; Transforaminal Epidural Steroid Injection; Percutaneous Laser Disc Decompression; Minimally Invasive Spine Treatment; PLDD
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Radiculopathy; Intervertebral Disc Displacement
• Other Study ID Numbers: MU-PLDD-TFESI-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared due to patient confidentiality considerations and institutional data protection policies. The collected data will be used solely for the purposes of this study and related scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No