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临床试验/NCT03389906
NCT03389906已完成不适用

Inflammation Impact on Pain in Patients With Knee Osteoarthritis

Sten Rasmussen, MD, PhD2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2017年12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
32
试验地点
2
主要终点
WOMAC

研究概览

简要总结

The aim of this study is to use gold particles as a model compound to modulate specifically and selectively the function of macrophages and mast cells and investigate how this modulates pain and pain sensitization in the osteoarthritic knee assessed by mechanistic pain assessment technologies

详细描述

Osteoarthritis (OA) of the knee and hip is the most common musculoskeletal joint disease worldwide. Although a major symptom of OA is chronic joint pain, which has a significant effect on patients' quality of life, the pain mechanisms remain largely unknown.

Recently, clinical studies have suggested the existence of a neuropathic component in OA pain [5]. Accumulating evidence has been indicating that painful OA patients show peripheral and central sensitization [3,16]. Quantitative sensory testing (QST) is a relevant way to assess peripheral and central sensitization in joint pain [9]. The majority of studies have administered mechanical stimuli, and the most commonly used modality have been pressure. A recent review concluded that that people with OA have lower Pressure Pain Thresholds (PPT), facilitated temporal summation and impaired conditioned (CPM) compared with healthy controls [5]. Also, recent evidence have link QST profiles to the development of chronic pain [29,38], which emphasises the importance of studying the central nervous system.

Inflammation markers have been correlated with the pain intensity [35], and systemic inflammation can leads to sensitization of peripheral nociceptors [1]. Recently it was reported that higher preoperative levels of TNF-α, MMP-13 and IL-6 in synovial fluid may indicate a smaller improvement in pain 2 years after TKR [15].

Injectable solutions of gold-thio-compounds have been used to treat rheumatoid arthritis for nearly 100 years [13,21]. Several studies suggest that gold ions reduces pain, joint swelling, inflammation, and increase joint motility [24,31,33]. Gold salt therapy (auranofin; RidauraR) has been vetted by the FDA and approved (May 1985) and recommended by the American College of Rheumatology as a Disease Modifying Anti Rheumatic Drug - DMARD (https://www.rheumatology.org).

Gold salts, whether injected or given orally, have been shown to be effective [33,37] in reducing joint pain. Studies report patients going to total remission [28] and others report a 30% reduction in symptoms [20,27]. In addition, Clark et al., 1997 [8] concluded in a Cochrane meta-analysis that systemic treatment with gold was highly effective compared to placebo.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Knee OA diagnosed based on the American College of Rheumatology criteria, KL (Kellgren-Lawrence) X-ray grade ≧ 2, pain for > 3months, maximal pain intensity VAS (visual analogue scale) ≧ 5 (0-10 scale) for the most painful knee during the last week. Knee joint effusion that can be aspirated

排除标准

  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous neurologic, musculoskeletal or mental illnesses
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial e.g. analgesics, anti-inflammatory drugs
  • Recent history of acute pain affecting the lower limb and/or trunk
  • Past history of a chronic pain condition
  • Participation in other pain trials throughout the study period

结局指标

主要结局

WOMAC

时间窗: 8 weeks, 2 years

The WOMAC\[6\] is a subject-rated instrument that measures Osteoarthritis (OA)

次要结局

  • Quantitative sensory testing(8 weeks)
  • Weekly pain diary(8 weeks)
  • Inflammatory markers(8 weeks)
  • PainDetect questionnaire (PD-Q(8 weeks, 2 years)
  • Global Rating of Change Scale(2 years)

研究者

发起方
Sten Rasmussen, MD, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sten Rasmussen, MD, PhD

Professor Head of Department of Clinical Medicine

Northern Orthopaedic Division, Denmark

研究点 (2)

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