Comparison Between 10% Dextrose Injection and Triamcinolone as an Adjuvant to Pulsed Radiofrequency of the Dorsal Root Ganglion in Patients With Herniated Nucleus Pulposus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain intensity measured by the Numeric Rating Scale (NRS)
研究概览
简要总结
Lumbar herniated nucleus pulposus (HNP) is a common cause of chronic low back pain and radiculopathy. Transforaminal epidural steroid injection is commonly used as an adjuvant following pulsed radiofrequency (PRF) treatment but is associated with potential steroid-related adverse effects. Ten percent dextrose has been proposed as a regenerative, non-steroidal alternative. This single-blind randomized controlled trial compares the effectiveness of transforaminal epidural 10% dextrose versus triamcinolone administered after PRF in reducing pain, disability, and neuropathic pain in patients with lumbar HNP over a 14-day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to treatment allocation. The investigator performing the intervention is aware of the assigned treatment because of differences in the study medications. Outcome assessments are conducted according to the study protocol.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years.
- •Diagnosed with lumbar herniated nucleus pulposus (HNP) confirmed by magnetic resonance imaging (MRI).
- •Chronic low back pain and/or radicular pain for at least 3 months.
- •Numeric Rating Scale (NRS) pain score ≥
- •No indication for surgical intervention.
- •Eligible for pulsed radiofrequency of the dorsal root ganglion with transforaminal epidural injection.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Previous lumbar spine surgery.
- •Progressive neurological deficits or cauda equina syndrome.
- •Indication for immediate spinal surgery.
- •Known hypersensitivity to dextrose, triamcinolone, local anesthetics, or study medications.
- •Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued.
- •Local or systemic infection.
- •Pregnancy or breastfeeding.
- •Uncontrolled diabetes mellitus or other severe uncontrolled systemic disease.
- •Severe psychiatric illness or cognitive impairment affecting study participation.
- •Participation in another interventional clinical trial.
- •Inability or unwillingness to complete the scheduled follow-up assessments.
研究组 & 干预措施
10% Dextrose Group
干预措施: 10% Dextrose Injection (Drug)
Triamcinolone Group
干预措施: Triamcinolone Injection (Drug)
结局指标
主要结局
Pain intensity measured by the Numeric Rating Scale (NRS)
时间窗: Baseline, 2 hours, 24 hours, 48 hours, 7 days, and 14 days after intervention
Pain intensity will be assessed using the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity.
次要结局
- Functional disability measured by the Oswestry Disability Index (ODI)(Baseline and 14 days after intervention)
- Neuropathic pain measured by the Neuropathic Pain Scale (NPS)(Baseline and 14 days after intervention)
- Patient satisfaction(14 days after intervention)
- Adverse events(From intervention through 14 days after intervention)
研究者
Pryambodho Pryambodho
Principal Investigator
Indonesia University