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临床试验/CTRI/2023/12/060703
CTRI/2023/12/060703尚未招募2 期

Effectiveness of fluoroscopy guided cryoablation of genicular nerves in comparison with steroid and local anaesthetic block in improving pain and function in patients with grade 3 and 4 osteoarthritis of knee: A randomised controlled trial

Regional Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年12月31日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
82
试验地点
1
主要终点
Knee pain measured by VAS

研究概览

简要总结

Knee osteoarthritis is a progressive chronic degenerative musculoskeletal disease of the knee joint which is the most commonest rheumatological condition causing pain, functional impairment, chronic disability, and diminished quality of life. Diagnosis will be made by the 2016 ACR criteria for early diagnosis of knee osteoarthritis. Treatment should aim to relieve pain, improve function, limit disabilities, and improve quality of life. Surgery is the definitive management of the later stages of OA knee. So later stages of the disease and associated chronic pain should be treated wisely with minimal side effects.  Cryoablation of genicular nerves has recently become popular in the management of chronic osteoarthritic knee pain due to its potential of allowing for complete regeneration and functional recovery of nerves with fewer adverse effects. The greatest limitation of cryoablation is the lack of standardization. This study a single-blinded randomized controlled trial shall be conducted in the Department of Physical Medicine and Rehabilitation to determine the effectiveness of fluoroscopy-guided cryoablation in comparison with local anaesthetic and steroid block of genicular nerves in the treatment of patients with grade 3 and 4 osteoarthritis of the knee. A sample size of 82 patients of grade 3 and 4 osteoarthritis of knee attending PMR OPD, RIMS with knee pain will be chosen and randomized. Outcomes will be measured using the VAS (Visual Analogue Scale) and WOMAC at baseline, and post-intervention at 1st, 4th, 12th, and 24th weeks. For calculation, the Chi-square test, independent t-test, and repeated measure ANOVA will be used and a p-value <0.05 will be taken as significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Persons with osteoarthritis of the knee as per 2016 revised ACR criteria for early diagnosis of osteoarthritis
  • •Osteoarthritis of the knee with Kellgren Lawrence grade 3,4
  • •Duration of symptoms more than 3 months
  • •Age 40 to 70 years
  • •Positive diagnostic block (>50% improvement in pain)
  • •Willingness to participate in the study and comply with treatment and follow up.

排除标准

  • •Acute knee injury/pain
  • •Prior knee surgery
  • •Serious neurologic/psychiatric disorder/cognitive impairment
  • •Intra articular injection with steroids/hyaluronan in the last 3 months
  • •Recent myocardial infarction or stroke
  • •Uncontrolled diabetes and hypertension/systemic diseases
  • •Coagulation disorder
  • •Local or systemic infections
  • •Allergy to anaesthetic medication (Lignocaine and Bupivacaine) and steroids used.

结局指标

主要结局

Knee pain measured by VAS

时间窗: At the end of 1st week, 4th week 12th week, and 24th week

次要结局

  • Functional outcome by WOMAC score.(At the end of 1st week, 4th week 12th week, and 24th week)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Priyanka S U

Regional Institute of Medical Sciences

研究点 (1)

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