Pain Processing Mechanisms in Patients With Juvenile Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Pressure pain thresholds (PPT) (measured in kilopascal)
研究概览
简要总结
Juvenile idiopathic arthritis (JIA) is the most common rheumatologic disease in children. The main symptoms of JIA, which are often the primary focus of treatment, include joint swelling, stiffness, and tenderness. Additional symptoms can include malaise, fatigue, and pain. However, the exact mechanisms contributing to pain are not yet fully understood. Participants will complete a 2.5-hours study session.
In the study session, psychophysical assessments of thermal and pressure stimuli will be performed. In addition, demographic, social, pubertal maturation, and behavioral and psychological factors will be collected via questionnaires. A saliva sample and/or blood draw may occur for the analysis of various immune factors and sex hormones. If a joint aspiration is done as part of their standard of care, we will request a sample of the synovial fluid for analyses of immune, hormonal and/or genetic factors. Participants will have the option to participate in additional optional follow-up study visits (every 3 months, up to 1 year) and to complete monthly surveys asking about their juvenile arthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 9-17
- •Males and females
- •English speakers
- •Able to complete surveys and understand study instructions
- •Juvenile arthritis group: diagnosed or suspected of juvenile arthritis
- •Control group: healthy
排除标准
- •Pregnancy or breastfeeding
- •(Control Group) Diagnosed with a chronic pain condition
- •(Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.
研究组 & 干预措施
Controls
Inclusion:
- Age between 9-17
- Males and females
- English speakers
- Able to complete surveys and understand study instructions
- Healthy
Exclusion Criteria
Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Pregnancy or breastfeeding
- (Control Group) Diagnosed with a chronic pain condition
- (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.
干预措施: Pressure pain thresholds (measured in kilopascal) (Behavioral)
JIA
Inclusion:
- Age between 9-17
- Males and females
- English speakers
- Able to complete surveys and understand study instructions
- Diagnosed or suspected of juvenile arthritis
Exclusion Criteria
Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Pregnancy or breastfeeding
- (Control Group) Diagnosed with a chronic pain condition
- (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.
干预措施: Cold pain tolerance (duration in seconds) (Behavioral)
JIA
Inclusion:
- Age between 9-17
- Males and females
- English speakers
- Able to complete surveys and understand study instructions
- Diagnosed or suspected of juvenile arthritis
Exclusion Criteria
Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Pregnancy or breastfeeding
- (Control Group) Diagnosed with a chronic pain condition
- (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.
干预措施: Pressure pain thresholds (measured in kilopascal) (Behavioral)
Controls
Inclusion:
- Age between 9-17
- Males and females
- English speakers
- Able to complete surveys and understand study instructions
- Healthy
Exclusion Criteria
Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion:
- Pregnancy or breastfeeding
- (Control Group) Diagnosed with a chronic pain condition
- (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.
干预措施: Cold pain tolerance (duration in seconds) (Behavioral)
结局指标
主要结局
Pressure pain thresholds (PPT) (measured in kilopascal)
时间窗: 1 year
Differences in PPT between patients and controls. Pressure will be increased continually and participants will be instructed to press a button the first moment they feel pain from the pressure stimulus. The first threshold measurement will be used as a familiarization. The average threshold is calculated from three measurements. Higher value indicates lower experimental pain sensitivity
Cold pain tolerance (duration in seconds)
时间窗: 1 year
Differences between patients and controls Cold pain tolerance will be assessed by having participants immerse their hand or foot in a cold (4-12°C) water bath. Tolerance will be defined by the time of hand withdrawal. Pain ratings of cold pain intensity might be obtained periodically, and both pain intensity and pain unpleasantness will be recorded upon hand/foot withdrawal. Higher value indicates lower experimental pain sensitivity
次要结局
未报告次要终点
研究者
Hadas Nahman-Averbuch
Assistant Professor
Washington University School of Medicine