NCT07217782

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
113mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Sep 2025Sep 2035

Study Start

First participant enrolled

September 15, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 16, 2025

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2035

Last Updated

October 16, 2025

Status Verified

October 1, 2025

Enrollment Period

5 years

First QC Date

September 19, 2025

Last Update Submit

October 14, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    1 year

  • 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

    1 year

Study Arms (2)

JIA

OTHER

Inclusion: 1. Age between 9-17 2. Males and females 3. English speakers 4. Able to complete surveys and understand study instructions 5. 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: 1. Pregnancy or breastfeeding 2. (Control Group) Diagnosed with a chronic pain condition 3. (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.

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

Controls

OTHER

Inclusion: 1. Age between 9-17 2. Males and females 3. English speakers 4. Able to complete surveys and understand study instructions 5. Healthy Exclusion Criteria Participants will not be enrolled if any of the following criteria exist and based on the investigator discretion: 1. Pregnancy or breastfeeding 2. (Control Group) Diagnosed with a chronic pain condition 3. (Control Group) Diagnosed with psychiatric condition including ADHD, anxiety, depression, etc.

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

Interventions

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

ControlsJIA

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

ControlsJIA

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63017, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Time

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Hadas Nahman-Averbuch, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alana McMichael, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2025

First Posted

October 16, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

September 1, 2030

Study Completion (Estimated)

September 1, 2035

Last Updated

October 16, 2025

Record last verified: 2025-10

Locations