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临床试验/NCT01545258
NCT01545258已完成不适用

Exercise and Changes in Pain Sensitivity in Patients With Knee Osteoarthritis

Frederiksberg University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年3月1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
60
试验地点
2
主要终点
Change from baseline in mechanical pain sensitivity

研究概览

简要总结

A commonly administered conservative non-pharmacological treatment for OA is exercise, with beneficial effects in terms of reduced pain and disability.

While the link between exercise and reduced disability is mediated by e.g. increased muscle strength and endurance, the analgesic mechanisms related to exercise are unexplored. knee OA patients have both peripheral and central sensitization of pain mechanisms resulting in hyperalgesia. Thus, targeted pain treatment in these patients may focus on both peripheral and central mechanisms but it unknown if exercise affects either of these mechanisms.

It is hypothesized that in knee OA patients exercise reduces the pain sensitivity

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Age above 40 years
  • Clinical diagnosis of tibiofemoral osteoarthritis
  • Radiographic verification of diagnosis (Kellgren&Lawrence 2 or 3)
  • Ability to participate in examinations
  • Ability to participate in exercise sessions
  • 20≤ Body Mass Index (BMI) ≤35 kg/m2
  • Ability to comply with rules about concomitant medication and therapy
  • Speak, read and write Danish

排除标准

  • Participation in exercise training for the knee osteoarthritis within 3 months of enrollment
  • Counterindications for exercise
  • Pregnant or breastfeeding
  • Current or previous autoimmune disease
  • History of surgical joint replacement in the lower limbs
  • Planned surgery
  • Current or previous diagnosis or signs of cardiovascular disease
  • Neurological disorders
  • Alcohol or drug abuse
  • Psychiatric disorders
  • Regional pain syndromes
  • Regional pain caused by lumbar or cervical nerve root compression
  • Counterindications to MR scan
  • Counterindications to MR contrast

结局指标

主要结局

Change from baseline in mechanical pain sensitivity

时间窗: Baseline and at 12 weeks

Pain thresholds and temporal summation of pain

次要结局

  • Change from baseline in proinflammatory cytokines and biomarkers of cartilage breakdown in blood and urine(Baseline and at 12 weeks)
  • Change from baseline in patient reported pain and function(Baseline and at 12 weeks)
  • Change from baseline in functional pain test(Baseline and at 12 weeks)
  • Change from baseline in imaged based quantification of inflammation in the knee(Baseline and at 12 weeks)

研究者

发起方
Frederiksberg University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marius Henriksen

Senior researcher

Frederiksberg University Hospital

研究点 (2)

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