Randomized Controlled Trial on Comparison of Facet Joint Radiofrequency Denervation vs Facet Joint Steroid Injection in Chronic Low Back Pain of Facet Origin
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Low Back Pain intensity as measured by the NRS (0-10)
研究概览
简要总结
Systematic reviews and guidelines suggest that radiofrequency denervation can provide clinically meaningful pain relief for 6-12 months or longer. However, the relative effectiveness of radiofrequency denervation compared to intra-articular steroid injection remains uncertain.
There is a need for additional high-quality, randomized studies evaluating the comparative effectiveness of these two approaches for facet-mediated low back pain.
This randomized controlled trial aims to compare the effectiveness of RF denervation versus intra-articular steroid injection for chronic lumbar facetogenic pain not responding to conservative management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Chronic low back pain of at least 3 months duration
- •Clinical features suggestive of facet joint origin, including paraspinal tenderness, pain worsened by extension and rotation, and absence of radicular symptoms
- •Failure of conservative therapy, including medications (e.g., NSAIDs, weak opioids) and physical therapy, for at least 6 weeks.
排除标准
- •Presence of radicular pain or neurological deficits suggestive of nerve root involvement.
- •Previous lumbar spine surgery.
- •Significant spinal pathology, such as fracture, tumor, infection, or instability.
- •Coagulopathy or systemic infection.
- •Allergy to study medications (local anesthetics, steroids).
- •Pregnancy or lactation.
- •Cognitive impairment or psychiatric illness that may interfere with assessment of outcomes.
结局指标
主要结局
Low Back Pain intensity as measured by the NRS (0-10)
时间窗: At baseline, 1 month, 3 months, 6 months and 1 year post treatment
次要结局
- Pain intensity measured by the VAS (0-100 mm)(Functional status assessed by the Modified ODI at baseline and all follow-up visits)
研究者
Stanzin Spalkit
AIIMS New Delhi