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临床试验/CTRI/2025/02/080184
CTRI/2025/02/080184尚未招募4 期

COMPARISON EVALUATION OF ULTRASOUND GUIDED Vs FLUOROSCOPIC GUIDED PULSED RADIOFREQUENCY NEUROTOMY OF MEDIAL BRANCH IN LUMBAR FACETOGENIC PAIN: A PROSPECTIVE RANDOMISED STUDY

Dr Manasa Kantha1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年2月25日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare the pre-intervention pain scores NRS to scores 1 month post intervention.

研究概览

简要总结

This study evaluates comparison of ultrasound and fluoroscopic guided medial branch PRF in lumbar facetogenic pain, there is extensive research on medial branch blocks but limited research available for medial branch PRF. By keeping in mind regarding the hazards of radiation and operator learning curve, I want to do research on the above study. USG guided is non-inferior to fluoroscopic guided Medial branch PRF.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • facet Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions Suspicion of facet joint mediated low back pain, exhibit clinical features consistent with possible lumbar zygapophysial joint pain, such as pain and tenderness over not more than two lumbar segments bilaterally or three segments unilaterally patient had to be able to understand and tolerate diagnostic blocks; patient has to be positive for lumbar facet joint pain after controlled diagnostic blocks Pain rating of more than 4 out of 10 on a NRS scale Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.
  • Symptom duration of 3 or more months.

排除标准

  • Pain for less than 3 months Neurological deficits Pregnancy and lactating mother Prior low back surgery with or without hardware Concurrent cervical or thoracic pain or pain in these regions lasting longer than 2 weeks during the previous 6 months Primary or metastatic spine tumour or spinal cord injury.
  • Allergy to medications used in procedure, blood coagulation disorder Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.
  • Patients with rheumatic cause of lumbar facet arthritis.
  • Local or systemic infection or spinal infection Compensable disability or work injury, ongoing litigation, Prior treatment with radiofrequency neurotomy, and Discogenic pain verified by controlled discography.

结局指标

主要结局

To compare the pre-intervention pain scores NRS to scores 1 month post intervention.

时间窗: one month post intervention

次要结局

  • 1. Change in pain NRS with back flexion and at rest from baseline after intervention from baseline after intervention over time [ Time Frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention ](2. To compare change in McNab Scores at 1 week, 1 month and 3 months.)

研究者

发起方
Dr Manasa Kantha
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Manasa Kantha

All India Institute of medical sciences Rishikesh

研究点 (1)

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