跳至主要内容
临床试验/CTRI/2024/09/073587
CTRI/2024/09/073587尚未招募1 期

Comparison of Functional Improvement in patients of chronic low back pain with facet joint syndrome undergoing Cooled radiofrequency ablation vs Conventional Thermal Radiofrequency Ablation

DrJyotsana Chauhan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Effectiveness and safety and functional improvement by Oswestry Disability Index (ODI) of cooled radiofrequency ablation versus conventional radiofrequency ablation (cRFA) for the treatment of chronic low back pain associated with lumbar facet joint dysfunction.

研究概览

简要总结

Lumbar facet dysfunction is a common cause of chronic low back pain, affecting millions of individuals worldwide. Facet joints are well known source of axial lower back pain, and the prevalence of facet joint pain varies from 20% to 44%. The clinical diagnosis of facet joint mediated pain is challenging due to inadequate sensitivity and specificity of clinical and radiological test. Therefore, medial branch blocks are used for diagnostic purposes in refractory cases, and may provide prognostic value before proceeding with radiofrequency ablation. The diagnostic blocks and radiofrequency treatments are validated in the facet joint mediated lumbar spinal pain. Majority of the studies in the literature are based on the traditional radiofrequency ablation (TRFA) procedure which was proved to be a safe. Effective, and leading pain therapy used to create sensory dysfunction in appropriate nerves via thermal energy. Water-cooled radiofrequency (CRFA) is a newer technique and may have some theoretical advantages over traditional radiofrequency (TRFA). This technology. Similar to TRFA, is also based on the heat neurotomy (60°C in CRFA versus 70-80°C in TRFA). Water circulation (at room temperature) through an isolated channel around the electrode tip creates a continuous “cooling” of the needle tip; consequently, the procedure typically results in a larger spherical- shape ablative area, with a diameter twice as long and extending distally from the tip of the electrode. Thus, CRFA may theoretically increase the success of radiofrequency ablation of the target nerves due to coverage of wider ablative area. As very few studies are present in literature comparing the two modalities Cooled RFA and Conventional RFA. In this prospective comparative non inferiority study, we aim to compare the efficacy, functional outcome, pain relief and complications, in patients undergoing Cooled RFA verses Conventional RFA.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria- a) Patient of chronic low back pain due to lumber facet syndrome diagnosed by controlled diagnostic ‘median branch block’.
  • b) Age 18-80 of either sex.
  • c) Refractory to conservative treatment including activity modification, home exercise, physical therapy, medication.

排除标准

  • Exclusion Criteria- a) Patient who declined consent.
  • b) Patient having history of drug allergy.
  • c) Patient with coagulation abnormality or local site infection.
  • d) Pregnant patient and patient with pacemaker in situ.
  • e) Disc herniation, stenosis, myelopathy, lumbar facet.

结局指标

主要结局

Effectiveness and safety and functional improvement by Oswestry Disability Index (ODI) of cooled radiofrequency ablation versus conventional radiofrequency ablation (cRFA) for the treatment of chronic low back pain associated with lumbar facet joint dysfunction.

时间窗: Data will be collected at baseline, post intervention, I month, 3 months 6 months post.intervention Statistical analysis will be performed to compare outcomes

次要结局

  • Secondary: Visual analog scale (VAS) for pain intensity, multifidus muscle thickness measured by ultrasound, PGIC (Global Patient Impression of Change- Patient Satisfaction)

研究者

发起方
DrJyotsana Chauhan
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

DR Shivani Rastogi

DR.R.M.L INSTITUTE OF MEDICAL SCIENCES, VIBHUTI KHAND,GOMTI NAGAR, LUCKNOW.

研究点 (1)

Loading locations...

相似试验

Comparison of Improvement in pain tolerance and... | 临床试验