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临床试验/NCT07400068
NCT07400068尚未招募不适用

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

Mersin University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2026年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
88
试验地点
1
主要终点
Change in Leg Pain Intensity (NRS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Inability to complete follow-up assessments

研究组 & 干预措施

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.

干预措施: Percutaneous Laser Disc Decompression (PLDD) (Procedure)

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.

干预措施: Transforaminal Anterior Epidural Steroid Injection (Procedure)

结局指标

主要结局

Change in Leg Pain Intensity (NRS)

时间窗: Baseline to 1 month after procedure

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.

次要结局

  • Change in Back Pain Intensity (NRS)(Baseline to 1 month after procedure)
  • Functional Disability (Oswestry Disability Index)(Baseline to 1 month after procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mesut Bakır

Associate Professor of Anesthesiology and Algology

Mersin University

研究点 (1)

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