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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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) |
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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
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mesut Bakır, Assoc.Prof | Contact | +905457450655 | mesutbakir@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mesut Bakır | Mersin University Faculty of Medicine, Pain Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mersin University Faculty of Medicine, Department of Algology | Mersin | Yenişehir | 33130 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25919616 | Background | 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. | |
| 22828691 |
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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.
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| 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. |
|
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 |
| 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. |
| 15591287 | 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. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |