跳至主要内容
临床试验/CTRI/2022/09/046007
CTRI/2022/09/046007尚未招募不适用

Comparative evaluation of ultrasound-guided and fluoroscopic-guided facet joint injection in patients with facet joint pain- a prospective randomized controlled trial

All India institute of medical sciences Rishikesh1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年1月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
94
试验地点
1
主要终点
Pain score [11-point numeric rating scale (NRS 11) score] in both the groups

研究概览

简要总结

Lumbar facet joints have been implicated in the cause of chronic low back pain in 15% to 45% of patients, which was based upon their responses toward controlled, diagnostic blocks according to the criteria set by the International Association for the Study of Pain. Treatment effects for facet join pain in 3 types of intervention, including intraarticular injection, medial branch nerve block, and neurolysis using radiofrequency, have been reported. These treatment options have been implicated in refractory cases of facet joint pain who are not responsive to conservative management. Appropriate management methods for the facet joint pain are still in argument. Facet joint intra-articular (IA) injection are conventionally and preferably performed under fluoroscopy (FL) or computed tomography (CT)-guided. Both guidance modalities deliver significant radiation doses and require, at least in part, expensive equipment. However, an ultrasound (US)-guided approach can be safe and reliable without radiation exposures. Recently, many studies have demonstrated the reliability of ultrasound (US) guidance for different spinal injections. Ultrasound provides real-time monitoring, is a relatively inexpensive image guidance modality, does not produce ionizing radiation, and is broadly available.

We hypothesized that US-guided facet IA injection provides non-inferior analgesic efficacy and functional outcome as compared to conventional FL-guided injection without any risk of radiation exposure with added advantages of cost-effective, feasible, easily accessible, portable, and real time visualization of needle and surrounding structure.

Very few trials have been conducted till date. Therefore,we planned this trial with the aim to evaluate the comparative efficacy of thetwo different image-guided (US-guided and FL-guided) modalities in performingfacet joint intra-articular (IA) injections in patients with chronic lumbar facetjoint syndrome in terms of pain relief and quality of life improvement

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Chronic LBP with or without proximal non-radicular extremity pain
  • Duration of pain at least more than 3 months
  • Pain unresponsive to conservative treatment including medical management, physical therapy, and previous interventions.
  • Average pain score of ≥4 on an 11-point NRS.

排除标准

  • Patient refusal
  • more than one facet joint or bilateral facet joint involvement
  • Pain for less than 3 months
  • Coagulopathy and/or patients on anticoagulants.
  • Infection at the site of injection.
  • Hypersensitivity to local anesthetic agent.
  • Evidence of significant progressive sensory or motor deficit, cauda-equina syndrome, H/O trauma, infection and cancer (Red flag signs).
  • Evidence of severe psychiatric illness.
  • History of spinal tumor, spinal cord injury or previous backs surgery 10.History of any major comorbid medical conditions, those interfere with recording of study outcomes (neurological disorders, auto-immune diseases), multiple sclerosis, and pregnancy.

结局指标

主要结局

Pain score [11-point numeric rating scale (NRS 11) score] in both the groups

时间窗: 1 week, 1 month, 3 months

次要结局

  • 1. GPE (Global Perceived Effect) as measured by Likert scale 7-point scoring system to assess patient satisfaction and improvement.(2. Improvement in functional status as measured by Ronald Morris Questionnaire at respective time intervals.)

研究者

申办方类型
Research institution

研究点 (1)

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