NCT07360444尚未招募不适用
Safety and Efficacy of Radiofrequency Ablation of Rammii Communicans Versus Annuloplasty or Both Together in Discogenic Back Pain Patients Double-Blinded Randomized Controlled Trial
Esraa Fathy Radwan Abd Elzaher0 个研究点目标入组 90 人开始时间: 2026年1月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
研究概览
简要总结
Aim of the study
Comparing the safety, efficacy, pain reduction, and functional disability between Ramii communicans radiofrequency versus Annuloplasty versus combined both techniques in patients with discogenic low back pain
Patient and methods
• Study design: Prospective, randomized, double-blinded control clinical trial study.
• Study suite: The study will be conducted in the pain management unit at the Department of Anesthesia and Pain Management, Assiut University Hospital, after approval of the local ethical committee.
• Time of study: from January 2026 till the recruitment of all patients.
The PICOT algorithm is preliminarily pointed out:
- P (Population): patients complaining of Discogenic back pain with failed conservative treatment
- I (Intervention) Patients scheduled for Rammii Communicans Radiofrequency Ablation
- C (Comparison): patients scheduled for Annuloplasty Radiofrequency Ablation
- O (Outcomes): Assess safety, Efficacy, pain reduction (assessed by Numeric Rating Scale), functional disability (assessed by Oswestry Disability Index), and Depression score (SF-36) between the two groups
- T (Timing): 2weeks,1 month,3 months, and 6 months of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were 18 years or older
- •Chronic LBP persisted for more than three months
- •Failed medical treatment
- •Axial LBP with or without leg radicular pain experienced pain exacerbation by sitting (intolerance to sitting), bending forward, coughing or sneezing, and partially relieved with lateral recumbent position, standing, or walking.
- •Patients with a Numeric Rating Scale of pain severity of five points or higher, specifically to the daily LBP, were included in the study.
- •The examination criteria for the study included tenderness on deep pressure of the spine process at the level of the degenerated disc and no neurological motor deficits.
- •The magnetic resonance imaging (MRI) criteria required images to show clear evidence of degenerative disc disease in one or two-disc levels that include a high intensity zone (HIZ) in the posterior annulus and dark disc with or without loss of height
排除标准
- •Encompassed patients with clinical evidence of progressive motor neurological deficits,
- •MRI evidence of intervertebral disc herniation measuring 4 mm or more, sequestration, extrusion, disc space collapse, or spondylolisthesis at the symptomatic level.
- •Patients with moderate to-severe central spinal canal or foraminal stenosis,
- •Previous lumbar surgery at the same treatment level,
- •Spinal fractures, deformities
- •Infections or tumors
- •Patients with psychotic illnesses, uncontrolled diabetes, advanced hepatic conditions, current pregnancy, recent delivery (within three months of consent), intent to become pregnant during the study period, and local sepsis or skin inflammation in the back region.
研究者
Esraa Fathy Radwan Abd Elzaher
dr
Assiut University
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