An observational study in Lumbar Disc Herniation and Lumbar Radiculopathy, sponsored by Mersin University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Mersin University · Observational
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.
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.
478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.
This study's planned enrollment of 88 is below the median of 100 across 121 observational studies indexed under Intervertebral Disc Displacement.
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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.
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
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)
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 minimally invasive laser-based disc decompression performed under fluoroscopic guidance to reduce intradiscal pressure in patients with lumbar disc herniation.
Routine transforaminal anterior epidural injection of dexamethasone performed under fluoroscopic guidance following PLDD during the same session without additional puncture.
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
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
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
Plan to share: No — 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.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Mersin University