跳至主要内容
临床试验/CTRI/2024/04/066335
CTRI/2024/04/066335已完成不适用

Does thermotherapy lead to decreased analgesic requirement in patients with osteoarthritis of knee managed non-surgically.

AIIMSRajkotGujarat1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2024年5月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
312
试验地点
1
主要终点
- WOMAC score

研究概览

简要总结

Osteoarthritis knee constitutes one the most common ailments presenting to orthopaedic OPD and society in general. NSAIDs constitute the mainstay of treatment and can relieve pain effectively, but they  also have side effects. The risk of side effects depends on age and comorbidity patient may have. People who already have other illnesses, like renal,hepatic and gastrointestinal diseases, may not tolerate them well. Drug interaction is also a challenge in using NSAIDs. Thermotherapy(cold and heat) has shown effectiveness in relieving pain and discomfort of knee osteoarthritis.  In contrast to NSAIDs, no adverse effects of the thermotherapy were reported in the literature. No consideration of drug interaction and no optimization in view of comorbidity is needed.However standardized and scientific study to prove this fact is lacking.A well designed two arm study comparaing NSAIDs and thermotherapy group will be helpful in giving more insight on this issue and making thermotherapy a standard treatment modality of degenerative knee disease.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Investigator 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

  • The patient with Knee pain of at least 6 months duration.
  • THe patients having Primary Osteoarthritis of knee(Kellgren Lawrence Grade 1,2,3,4) -The patients with Weight bearing X-rays of the knee showing OA knee.
  • Full ambulant patients.
  • Patients opting for conservative management of OA knee.

排除标准

  • The Patients with Infective pathology.
  • The patients having Focal chondral defects.
  • The patients with Post traumatic Osteoarthritis.
  • Those who are having Degenerative subluxation of the Knee joint.
  • Patient shaving Ligamentous instability.
  • Inflammatory arthritis.

结局指标

主要结局

- WOMAC score

时间窗: 3,6,9 weeks

- IKDC score

时间窗: 3,6,9 weeks

次要结局

  • VAS score(12 months)

研究者

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

Dr Abhishek Kumar Mishra

AIIMS,Rajkot

研究点 (1)

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