Comparison of Pulsed Radiofrequency Stimulation Versus Dexamethasone Applied to the Caudal Epidural Space for the Relief of Lumbar Spinal Stenosis Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Numerical rating scale (NRS)
研究概览
简要总结
The aim of this study was to compare the efficacy of caudal epidural steroid injection and caudal epidural pulsed radiofrequency stimulation in the relief of symptoms of lumbar spinal stenosis.
This evaluation used the numerical rating scale (NRS) to assess pain relief and the Medication Quantification Scale III (MQS III) to assess the effectiveness of the interventions on medication consumption. The rates of adverse events related to the interventions were also compared.
详细描述
Low back pain (LBP) is one of the leading causes of disability worldwide. Lumbar spinal stenosis is one of the three most common diagnoses of lower back and leg pain, along with intervertebral disc herniation and degenerative spondylolisthesis. Numerous treatment modalities have been proposed for the management of lumbar spinal stenosis, including drug therapy and complex surgical fusion. Epidural injections are a nonsurgical intervention commonly used in the treatment of spinal stenosis. Saline, local anesthetics, steroids, hylaze, platelet-rich plasma, and pulsed radiofrequency (PRF) administered to the caudal epidural space have been reported to be effective in the treatment of pain.
Among these, caudal epidural PRF has been applied in a limited number of chronic painful conditions (failed back surgery syndrome, chronic distal symmetrical polyneuropathy, postherpetic neuralgia, and coccygodynia), and no randomized controlled studies have been conducted. PRF produces a nonthermal effect that modulates the transmission of pain signals by delivering a short-term high-voltage electric current to the target nerve. RFT provides a continuous current that heats the target tissue and causes coagulation necrosis in nerves.
The primary aim of this study was to compare the efficacy of caudal epidural RFT and caudal epidural steroid injections in patients with lumbar spinal stenosis. The secondary aim was to determine the effects of the interventions on drug consumption and interventional safety, based on adverse events.
A total of at least 50 patients will be enrolled for comparison, with 25 in each group. NRS and MQS III scores will be compared both within and between groups before and 1, 2, and 3 months after treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Among the patients with lumbar spinal stenosis findings and narrowing of the spinal canal detected by examination and imaging methods, those whose back and leg pain persists for at least 3 months
排除标准
- •Previous lumbar surgery, pregnancy, history of ongoing malignant disease, autoimmune diseases, active infection of the injection site, hematologic disorders, antiplatelet drug use
结局指标
主要结局
Numerical rating scale (NRS)
时间窗: Change from baseline to 1st,2nd and 3th month after treatment
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
次要结局
- The Medication Quantification Scale III (MQS III)(Change from baseline to 1st,2nd and 3th month after treatment)
研究者
Damla Yürük
Supervisor Investigator
Diskapi Teaching and Research Hospital