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临床试验/NCT03048773
NCT03048773已完成不适用

Extracorporeal Shockwave Therapy for Knee Osteoarthritis

Taoyuan General Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
six minute walk test

研究概览

简要总结

Knee osteoarthritis is a common disease that causes joint pain, stiffness, and movement limitation. Nearly 50% in those 75 years and above are affected. In Taiwan, the reported prevalence was more than 6000 per year. The cause of pain is joint instability and structure changed, including hyaline articular cartilage lost, bony remodeling, capsular stretching and periartcular muscle weakness. Current guidelines for treatment of symptomatic knee osteoarthritis include exercise, anti-inflammatory drugs, transcutaneous electrical stimulation(TENS) and magnetic fields(MF) which reduce pain and improve the patient's quality of life.

However, conservative therapies and oral supplements have been evaluated but are without clear efficacy. Prolotherapy is an injection therapy for chronic musculoskeletal pain. One of the hypotheses is stimulating local healing and current study demonstrated clinical benefit for pain and improvement of function. The effects of multi-point injections were more pronounced in several studies than single-point injection.

Extracorporeal shock wave is common treatment for kidney stones, has been widely used in soft tissue diseases, such as calcified tendon lesions and plantar fasciitis. The theory of extracorporeal shock wave is energy of high-frequency vibration caused destruction of stones and other hard material and by increasing the rate of vascular regeneration in the injured area and increasing the rate of autologous tissue repair, possible biological processes include increased mesenchymal stem cell proliferation and differentiation, slowing the inflammatory response and antimicrobial efficacy. Current studies have shown equivalent clinical outcomes on calcific rotator cuff tendinopathy among extracorporeal shock wave therapy, sono-guided acupuncture and arthroscopic surgery and the extracorporeal shock wave has the advantage of non-invasive treatment.

Taking the advantages of non-invasive treatment of extracorporeal shockwave. We want to design a randomized control trial by multi-point shockwave therapy and physical therapy compared with placebo shockwave therapy and physical therapy. Two randomized controlled trial (RCT) reported improvement in outcomes in response to shockwave therapy but were not methodologically rigorous. The investigators therefore conducted a two-arm RCT to assess the hypothesis that adults with symptomatic knee pain receiving shockwave therapy will report greater improvement in knee-related quality-of-life than sham shockwave therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participant, Investigator, Outcomes Assessor

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient at Taoyuan general hospital rehabilitation outpatient department during 2017/01/01 ~ 2018/12/31
  • Diagnosis with knee osteoarthritis (ACR criteria or Kellgren and Lawrence grading II to IV)
  • Suitable for shockwave therapy and physical therapy with (TENS + MF + stretching + strengthening exercise)
  • Visual analog scale(VAS) ≧ 4

排除标准

  • Not suitable for shockwave therapy, including acute infection, osteomyelitis, coagulopathy, use of anticoagulants, pregnant women, patients with a pacemaker or implantable cardiac defibrillator
  • Patients who can't understand Chinese, including aphasia or dementia
  • Patient who can't receive 4 weeks of therapy
  • Patient who can't walk due to peripheral neuropathy or central nerve system diseases
  • Total knee arthroplasty
  • Shockwave therapy of knee for the prior 3 months
  • Skin defect or soft tissue infection over symptomatic knee
  • Other cause of knee pain which can't treat with physical therapy, including: rheumatoid arthritis, infection, fracture, ligament disruption

结局指标

主要结局

six minute walk test

时间窗: Change from baseline to week 3 and week 4

The distance covered in meters of six minute walk test

WOMAC score by Chinese version NRS 3.1

时间窗: Change from baseline to week 3 and week 4

次要结局

  • Visual analog scale (VAS)(Change from baseline to week 3 and week 4)

研究者

发起方
Taoyuan General Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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