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临床试验/NCT03740347
NCT03740347撤回不适用

Chronic Non-inflammatory Pains in Rheumatopediatrics

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家开始时间: 2018年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Frequency of chronic pain and its relationship with disease activity

研究概览

简要总结

The purpose of this study is to determine the frequency of chronic pain in adolescent with juvenile idiopathic arthritis, especially when the disease is inactive or with minimal activity.

Secondary objectives are, first to determine intensity of pain and its repercussion in daily life and second to determine risk factor of chronic pain.

详细描述

Juvenile idiopathic arthritis is the most frequent pathology in paediatric rheumatology clinic. Pain is an important symptom in paediatric rheumatology. It is actually poorly studied and is not evaluate in disease activity score like the Juvenile Arthritis Disease Activity Score (JADAS). It is source of handicap, social and psychological distress and greatly contribute to poor quality of life. Chronic pain is frequently multifactorial, even in inflammatory disease. In adult population, rheumatologists have shown an association between inflammatory disease like spondylarthritis or rheumatology polyarthritis and fibromyalgia.

There is no specific data on chronic pain in juvenile idiopathic arthritis. Pain is mostly evaluated by the Visual Analogue Scale (VAS) with no evaluation of pain repercussion on daily life or its chronicity. This study's primary objective is to determine the frequency of chronic pain and its relationship with disease activity. Secondaries objectives are to determine repercussion of pain in daily life, and risk factor of chronic pain.

To responded to this objective, we will conduct a transversal study in a paediatric rheumatology refence centre in Necker-Enfants malades Hospital. We will include all patients between 12 and 18 years old followed in our centre for any type of juvenile idiopathic arthritis.

Patients will be evaluated as usual by their paediatrics rheumatologist during a follow-up consultation or hospitalisation with the used of the clinical JADAS. Patient accepting to participate the study will be given a paper questionnaire evaluating chronic pain, its repercussion, anxiety (by the used of the Revised Children's Manifest Anxiety Scale (RCMAS score)), depression (by the used of the Children's Depression Inventory (CDI score)), Sleepiness (by the used of the Pediatric Daytime Sleepiness Scale (PDSS score)) and quality of life (by the used of the measurement model for the Pediatric Quality of Life inventory (PedQL score)).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child from 12 to 17 years old
  • Follow-up to Necker Hospital by a rheumatologist at the reference center for juvenile idiopathic arthritis (RAISE), regardless of the form
  • Not opposed to participating in the study

排除标准

  • No exclusion criteria

研究组 & 干预措施

Juvenile idiopathic arthritis and chronic pain

Patients followed for juvenile idiopathic arthritis and chronic pain in Necker Hospital

干预措施: Questionnaires (Behavioral)

结局指标

主要结局

Frequency of chronic pain and its relationship with disease activity

时间窗: Day 0

Chronic pain will be defined by the presence of recurrent or permanent moderate pain (Visual Analogue Scale (VAS) \> 3 / 10), present more than 3 days a week. Disease activity will be evaluated by the clinical Juvenile Arthritis Disease Activity Score (JADAS) and the definition of three groups: inactive disease, minimal disease activity and active disease.

次要结局

  • Repercussions of pain on patient anxiety(Day 0)
  • Repercussions of pain on patient daytime sleepiness(Day 0)
  • Chronic pain and disease repercussions(Day 0)
  • Repercussions of pain on depression symptoms(Day 0)
  • Repercussions of pain on quality of life(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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