跳至主要内容
临床试验/CTRI/2023/06/054401
CTRI/2023/06/054401已完成2/3 期

Comparing the effectiveness of Ultrasound guided Genicular Nerve block using 3 point approach versus 5 point approach for pain and quality of life in patients of chronic osteoarthritis of knee

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年3月7日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
TO COMPARE THE SEVERITY OF PAIN IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE, AFTER 1 MONTH AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING 11-POINT NUMERICAL RATING SCALE [NRS]

研究概览

简要总结

THIS IS DOUBLE BLINDED RANDOMISED CONTROLLED TRIAL COMPARING THE EFFECTIVENESS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH FOR PAIN AND QUALITY OF LIFE IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE. THE PRIMARY OUTCOME MEASURES THE SEVERITY OF PAIN POST PROCEDURE AT BASELINE, AFTER 1 MONTH AND AFTER 3 MONTHS IN BOTH THE GROUPS USING 11-POINT NRS. THE SECONDARY OUTCOME MEASURES THE QUALITY OF LIFE AND KNEE FUNCTION POST PROCEDURE AT BASELINE AND AFTER 3 MONTHS IN BOTH THE GROUPS USING KOOS AND TUG TEST RESPECTIVELY. THE MEAN SCORES OF BOTH GROUPS WILL BE COMPARED USING APPROPRIATE STATISTICAL METHODS.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • COMPLAINTS OF KNEE PAIN FOR AT LEAST 6 MONTHS WITH NRS >5/10
  • DIAGNOSED CASES OF CHRONIC OSTEOARTHRITIS OF KNEE ACCORDING TO AMERICAN COLLEGE OF RHEUMATOLOGY CRITERIA
  • GRADE 2-4 OSTEOARTHRITIS ACCORDING TO KELLGREN-LAWRENCE GRADING
  • RECEIVED CONSERVATIVE TREATMENT FOR AT LEAST 3 MONTHS.

排除标准

  • GRADE 4 OSTEOARTHRITIS WHO ARE CANDIDATES FOR TKR
  • PREVIOUS SURGICAL INTERVENTION DONE TO THE KNEE JOINT
  • PATIENTS WITH OTHER PATHOLOGY LIKE RHEUMATOID ARTHRITIS
  • PATIENTS WITH PERIPHERAL NEUROPATHY, SAPHENOUS NERVE ENTRAPMENT, RADICULOPATHY.
  • PATIENTS WITH BLEEDING DIATHESIS
  • PATIENTS WITH SERIOUS NEUROLOGICAL AND PSYCHIATRIC ILLNESS.

结局指标

主要结局

TO COMPARE THE SEVERITY OF PAIN IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE, AFTER 1 MONTH AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING 11-POINT NUMERICAL RATING SCALE [NRS]

时间窗: BASELINE | 1 MONTH | 3 MONTHS

次要结局

  • TO COMPARE KNEE FUNCTION IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING TIMED UP AND GO [TUG] TEST(BASELINE)
  • TO COMPARE QUALITY OF LIFE IN PATIENTS OF CHRONIC OSTEOARTHRITIS OF KNEE AT BASELINE AND AFTER 3 MONTHS OF ULTRASOUND GUIDED GENICULAR NERVE BLOCK USING 3 POINT APPROACH VERSUS 5 POINT APPROACH USING KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE [KOOS](BASELINE)

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR
申办方类型
Research institution and hospital

研究点 (1)

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