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临床试验/ITMCTR2000002934
ITMCTR2000002934尚未招募1 期

The long-term effect of acupuncture for patients with knee osteoarthritis: study protocol for a randomized controlled trial

The First Affiliated Hospital of He'nan University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
45 至 75(—)
性别
All

入选标准

  • 1. male or female, aged 45–75 years;
  • 2. diagnosis of knee osteoarthritis according to the American College of Rheumatology (ACR) criteria;
  • 3. radiologic confirmation of knee osteoarthritis(Kellgren–Lawrence grade?or III;
  • 4. the average daily pain over 40 points (on a 0-to 100-point scale);
  • 5. written consent to participate in the trial.

排除标准

  • 1. are unable to walk;
  • 2. have a serious infection of the knee;
  • 3. have suspected tears in any ligaments or menisci or acute inflammation of the synovial capsule;
  • 4. have a history of trauma, ligament damage, fracture, or surgery on the knee(s) within 6 months, causing pain or functional problems (history of knee replacement will be excluded);
  • 5. have a history of local tumour/malignancy at the knee;
  • 6. have physical or laboratory findings indicating infection, presence of autoimmune disease or inflammatory arthritis; 7. have knee pain caused by radiculopathy/herniation of an intervertebral disc;
  • 8. have end-stage diseases or other suspected severe conditions such as deep vein thrombosis of the lower limb, oedema related to cancer or cancer treatment, severe blood coagulation disorders, uncontrolled systemic arterial hypertension and severe diabetes;
  • 9. have a history of prolotherapy, hyaluronic acid injections or corticosteroids injections within 3 months;
  • 10. have received acupuncture, electro-acupuncture, Tui-na therapy, massage, or physiotherapy 8 weeks prior to enrolment in the trial;
  • 11. have severe pain in other regions;
  • 12. have severe mental disorder(s);are oversensitive to needles;
  • 13. and are insensitive to pain due to advanced diabetes, neuropathy or use of strong painkillers.

研究者

发起方
The First Affiliated Hospital of He'nan University of Chinese Medicine

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