Pain in Juvenile Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 9 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age between 9-17. 2. Males and females. 3. English speakers. 4. Able to complete surveys and understand study instructions. 5. Juvenile arthritis group: diagnosed or suspected of juvenile arthritis. 6. Control group: healthy.

Exclusion Criteria:

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07217782
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Washington University School of Medicine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hadas Nahman-Averbuch, PhD
Principal Investigator Affiliation Washington University School of Medicine
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Idiopathic Arthritis
Arms & Interventions

Arms

Other: JIA

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.

Other: Controls

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.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University School of Medicine, St Louis 4407066, Missouri 4398678

Status

Recruiting

Address

Washington University School of Medicine

St Louis 4407066, Missouri 4398678, 63017

Site Contact

Hadas Nahman-Averbuch, PhD

[email protected]

314-273-6194