Pain in Juvenile Arthritis
ConditionJuvenile Idiopathic Arthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age between 9-17
Males and females
English speakers
Able to complete surveys and understand study instructions
Disqualifiers
Pregnancy or breastfeeding
(Control Group) Diagnosed with a chronic pain condition
(Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
Pressure pain thresholds (measured in kilopascal)
BehavioralPressure 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)
BehavioralCold 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
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: JIAOther 2 interventions
Group B: ControlsOther 2 interventions
Trial outcomes
Primary outcomes
1
Pressure pain thresholds (PPT) (measured in kilopascal)
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
Time frame
1 year2
Cold pain tolerance (duration in seconds)
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
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov