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

NCT07400068 | Not Yet Recruiting

• 1 other identifier: MU-PLDD-TFESI-2026
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Disc Herniation; Lumbar Radiculopathy

Keywords

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

Outcome Measures

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.

  Baseline to 1 month after procedure

Secondary Outcomes (2)

• Change in Back Pain Intensity (NRS)

  Baseline to 1 month after procedure

• Functional Disability (Oswestry Disability Index)

  Baseline to 1 month after procedure

Study Arms (2)

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)

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

Interventions

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.

PLDD Plus Transforaminal Epidural Steroid Injection

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.

PLDD Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Faculty of Medicine, Department of Algology

Mersin, Yenişehir, 33130, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 25919616 BACKGROUND

• 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.

  PMID: 22828691 BACKGROUND

• 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.

  PMID: 15591287 BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mesut Bakır

  Mersin University Faculty of Medicine, Pain Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mesut Bakır, Assoc.Prof

CONTACT

+905457450655; mesutbakir@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology and Algology

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)