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临床试验/NCT06240000
NCT06240000已完成不适用

Comparison of the Effectiveness of Radiofrequency Ablation of the Superior Cluneal Nerve and Conventional Physical Therapy in Patients With Chronic Low Back Pain

Ankara City Hospital Bilkent2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Visual analog Scale

研究概览

简要总结

Low back pain is one of the most common musculoskeletal disorders affects individuals at least one during lifetime. Chronic low back pain (CLBP) lasts more than 3 months and decreases quality of life and causes work loss all over the world. Most common causes of Chronic Low back pain (CLBP) are lumbar disc herniation and/or degeneration, degenerative facet joints and sacroiliac joint pathologies, However, superior cluneal nerve (SCN) entrapment is another cause of CLBP that is ignored. It was reported that Superior cluneal nerve entrapment prevalence is % 1,6 - % 14 in CLBP patients. The Cluneal Nerves originate from the cutaneous branches of the dorsal ramus at T11-L4 and SCN innervates the skin of the upper part of the gluteal region. The nerves pass over the iliac crest through a tunnel formed by the thoracolumbar fascia and the upper edge of the iliac crest, that is the entrapment area. There are methods such as nerve blocks, neuromodulations and surgery in resistant cases. However, SCN entrapment is an overlooked diagnosis that should be considered in differential diagnosis.

Recently, radiofrequency ablation (RFA) of the SCN was performed under fluoroscopic guidance, total of 78% of patients reported nearly full analgesia for an average of 3 months. Although ultrasound-guided imaging and blocking of SCN is well described, there was not enough study that shows the effectiveness of ultrasound-guided SCN RFA and compares it to conventional physical therapy (CPT) in the treatment of CLBP.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suffering from chronic low back pain more than 3 months
  • VAS score ≥ 3/10
  • According to the blood samples, there should not be any detected bleeding diathesis (INR ≤1.2)
  • Patients detected positive 'iliac crest sign' included in the study

排除标准

  • Patients have pain score <3 according to the Visual Analog Scale (VAS)
  • INR >1.2 in blood samples
  • Radicular pain accompanying progressive neurological deficit
  • Sphincter disorder due to neurologic conditions
  • Local infections
  • Uncontrolled diabetes or other comorbidities leading general condition disorders
  • Allergic history related to used materials
  • Mental disorders worsen cooperation were excluded from the study.

结局指标

主要结局

Visual analog Scale

时间窗: Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed

Ten cm visual analog scale (VAS) was used by patients to perform a self-assessment of pain intensity associated with back pain. Higher scores indicate worse pain situations.

次要结局

  • Short-Form 36(Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed)
  • Oswestry Disability Index(Evaluated at baseline (pre-treatment), 2 weeks and 3 months after treatment completed)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hüma Bölük Şenlikci

Associate Professor

Ankara City Hospital Bilkent

研究点 (2)

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