Effectiveness of High-Voltage Pulsed Radiofrequency for Chronic Lumbosacral Radicular Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up
研究概览
简要总结
This randomized controlled trial compared high-voltage (60 V) and low-voltage (45 V) pulsed radiofrequency (PRF) for treating chronic lumbosacral radicular pain in adult patients. The study evaluated differences in pain reduction (using the Visual Analogue Scale [VAS] and Numeric Rating Scale [NRS-11]), functional ability (using Oswestry Disability Index scores), serum Interleukin-6 levels, and overall safety. All participants received fluoroscopy-guided PRF at 42°C for three 120-second cycles and were followed for approximately 6 weeks.
详细描述
Consecutive patients who met the inclusion and exclusion criteria were enrolled and randomized into two groups: the intervention group (high-voltage PRF, 60 V) and the control group (low-voltage PRF, 45 V). The sample size was calculated using the Neyman-Pearson approach with a superiority hypothesis, assuming that the intervention group would achieve greater pain reduction than the control group. Accounting for an estimated 20% dropout rate, 11 participants were required per group. Patients who voluntarily withdrew from the study were excluded from analysis, whereas patients who discontinued the intervention due to adverse effects during or after the procedure were included in the analysis and reported.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥ 18 years old
- •Numeric Rating Scale (NRS-11) ≥ 4 at screening
- •Clinical diagnosis of lumbosacral radicular pain with symptom duration ≥ 12 weeks
- •Insufficient response to conservative therapy, including but not limited to pharmacotherapy and/or physiotherapy
排除标准
- •Known hypersensitivity or allergy to medication required during the study (e.g., steroid, contrast media)
- •Coagulopathy, systemic infection, localized infection at needle-entry site, lumbar fracture, myelopathy, or severe organ dysfunction (e.g., renal failure, heart failure, severe respiratory diseases)
- •Comorbidities that compromise valid pain assessment (e.g., post-stroke, central neuropathy, malignancy)
- •Previous neurological deficits
- •Pregnancy
- •Refusal of participation in the study
研究组 & 干预措施
Standard/Low-Voltage PRF at 45 V
Pulsed Radiofrequency set the voltage at 45 V.
干预措施: Pulsed Radiofrequency (Device)
Standard/Low-Voltage PRF at 45 V
Pulsed Radiofrequency set the voltage at 45 V.
干预措施: Post-operative Analgesia (Drug)
High-Voltage PRF at 60 V
Pulsed Radiofrequency set the voltage at 60 V.
干预措施: Pulsed Radiofrequency (Device)
High-Voltage PRF at 60 V
Pulsed Radiofrequency set the voltage at 60 V.
干预措施: Post-operative Analgesia (Drug)
结局指标
主要结局
Change from Baseline in the Numeric rating scale (NRS-11) at Follow Up
时间窗: Baseline (pre-intervention) through study completion, an average of 6 weeks.
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Change from Baseline in the Visual Analog Scale (VAS) at Follow Up
时间窗: Baseline (pre-intervention) through study completion, an average of 6 weeks.
The Visual Analogue Scale (VAS) is determined by measuring the distance (in millimeters) from the patient's mark on a 100mm line to the left end of the line. The left endpoint is equivalent to "no pain" and right endpoint represents the "worst imaginable pain."
次要结局
- Change from Baseline in Oswestry's Disability Index Score at Follow Up(Baseline (pre-intervention) through study completion, an average of 6 weeks.)
- Change from Baseline in Serum Interleukin-6 at Follow Up(Baseline (pre-intervention) through study completion, an average of 6 weeks.)
研究者
dr. Farhan Ali Rahman, Sp. An-T.I., F.I.P.
Head of Education and Training Division RSUP Dr. Sardjito/Faculty of Medicine, Public Health, and Nursing Universitas Gadjah Mada
Gadjah Mada University