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临床试验/CTRI/2014/08/004821
CTRI/2014/08/004821招募中4 期

Oxaceprol versus tramadol in knee osteoarthritis: a randomized controlled trial.

Institute of Postgraduate Medical Education Research0 个研究点目标入组 100 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Clinically diagnosed cases of primary symptomatic OA affecting at least one knee joint (in case of bilateral knee involvement, the more symptomatic knee will be scored as the â??signal kneeâ??) fulfilling the following:
  • Age: Above 50 years
  • Sex: Either sex will be included
  • Knee joint pain present for at least one month in the preceding three months with at least one of the following: morning stiffness less than 30 min OR knee crepitus
  • Knee pain on movement of intensity at least 35 mm on a 100 mm VAS (Visual Analogue Score) scale.

排除标准

  • Secondary OA, such as due to injury, inflammatory condition, metabolic or rheumatic disease, osteonecrosis, Pagetâ??s disease, hemophilia etc.
  • Non-OA causes of knee pain in the signal knee (e.g. bursitis, fibromyalgia, osteonecrosis etc)
  • Prior intra-articular injection of hyaluronic acid / steroid / joint lavage in the study knee any time in the past three months.
  • Knee injury or diagnostic arthroscopy of signal knee within 6 months preceding enrollment or knee surgery (including arthroscopic surgery requiring an incision of the internal joint components) in the study knee, at anytime.
  • Severe and advanced OA disease, defined as joint space width 2 mm or deformed joint, or disease necessitating knee surgery in the current year.
  • Serious concomitant disease.
  • Subject unlikely to provide informed consent, follow the study protocol or any other criteria, which in the opinion of the investigator, is not conducive to enrollment of a particular subject into the trial.

研究者

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