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Recruiting NCT07217782

Pain in Juvenile Arthritis

No phase Interventional Juvenile Idiopathic Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pressure pain thresholds (measured in kilopascal), Cold pain tolerance (duration in seconds).
Who it may be relevant to
Registry conditions: Juvenile Idiopathic Arthritis. Basic parameters: 9 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Pain Processing Mechanisms in Patients With Juvenile Arthritis

Overview

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.

Interventions

  • Behavioral Pressure pain thresholds (measured in kilopascal)
    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
  • Behavioral Cold pain tolerance (duration in seconds)
    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

Primary outcome measures

  • Pressure pain thresholds (PPT) (measured in kilopascal) [Time frame: 1 year]
  • Cold pain tolerance (duration in seconds) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy or breastfeeding
  • (Control Group) Diagnosed with a chronic pain condition
  • (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Washington University School of Medicine — St Louis

Identifiers

NCT: NCT07217782 · 202505170

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗