Juvenile Idiopathic Arthritis (JIA)BRIDGE PainNCT07602595
Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain
An observational study of Juvenile Idiopathic Arthritis (JIA) and Fibromyalgia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of the study is to discover the underlying subtypes of chronic musculoskeletal pain (muscle and joint pain) in youth. Specifically, the researchers are looking for different profiles of brain and immune system signals that affect how the body feels pain, and how these pain profiles are shaped by a person's… Read more about this study
- Who is it for?
- Ages 14 to 26 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA), Fibromyalgia, Lupus
- What is being tested?
- Not applicable- observational study
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Aug 2029
- How long will I take part?
- 4 Weeks
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The participants in this study will come from several groups at Cincinnati Children's Hospital. These include teens and young adults with long-lasting widespread pain, patients already taking part in chronic muscle and bone pain studies, patients with childhood rheumatic diseases, and patients who have had major muscle or bone surgeries. If we need more participants, we will also recruit from the hospital's rheumatology and pain clinics. We plan to enroll 600 adolescents and young adults, ages 14 to 26, with equal numbers from each of the three study groups.
Who may be able to join
- Diagnosis of rheumatic/autoimmune disease/pain condition or initial MSK surgery prior to age 18
- Current age 14 to 26 years
- Participant (and parent/legal guardian of participants < 18 yo) can read and write in English
- At least 1 year from diagnosis of pain or rheumatic disease
- For individuals with MSK surgical history, at least 1 year after initial surgical intervention
- For individuals with rheumatic disease, their disease must be considered inactive
Who cannot join
- They have active disease (JIA or cSLE)
- Other medical conditions (e.g., malignancy, acute injury, surgery, infection) that impact current health status at the time of enrollment
- Currently pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45211
Megan Kirschman, 5136361846, bridgestudy@cchmc.org
About this study
The purpose of the study is to discover the underlying subtypes of chronic musculoskeletal pain (muscle and joint pain) in youth. Specifically, the researchers are looking for different profiles of brain and immune system signals that affect how the body feels pain, and how these pain profiles are shaped by a person's medical history, psychology, and social environment. The goal is to develop more precise treatments for chronic pain in young people.
Primary Aim: The investigators want to identify subtypes of childhood-onset chronic pain (pain lasting more than 3 months) that affects the musculoskeletal system. To do this, the study will enroll teens and young adults (ages 14-26 years) who were diagnosed with chronic pain in childhood (before the age of 18) or have a pediatric rheumatic disease or major surgery that places them at risk for developing chronic pain. The researchers will look at participants' childhood medical histories and treatments, their current pain and other symptoms, sensory tests of pain and immune system markers found in their blood. The investigators will use this information to find different clinical and neuroimmune profiles of chronic pain. They will also be able to identify the profiles of those who are at risk for chronic pain (because of a rheumatic disease or past surgery) but never develop long term pain.
Secondary Aim: The study will look at how medical history, treatments, and different lifestyle factors (like sleep and physical activity), and psychosocial factors (mood, coping, social support) influence the pain experience in subgroups of chronic pain identified in the primary aim. By understanding specific behavioral and psychosocial risk and protective factors-the researchers hope to better understand why some young people develop long-lasting pain and others do not and also how better treatments can be developed for those who do have chronic pain.
Read the detailed description
One in five children experience chronic pain with a large number experiencing primary musculoskeletal (MSK) pain conditions such as juvenile fibromyalgia and back pain. The number of youth with chronic MSK pain is even higher when considering those who develop chronic pain associated medical conditions (e.g., juvenile arthritis, childhood-onset lupus) or major surgery in childhood (scoliosis or pectus repair) - often referred as secondary MSK pain conditions. Current treatments are primarily based on symptom-management and fail to consider the underlying causes or subtypes of pain. As a consequence, many youth continue to suffer from disabling chronic pain into adulthood. The objectives of this study are to: 1) delineate mechanistically distinct subgroups of pediatric-onset chronic MSK pain based on clinical characteristics and neuro-immune profiles and 2) examine the psychosocial and behavioral influences that impact pain outcomes in these subgroups.
This clinical observational study will employ a mixed retrospective-prospective study design in which historical clinical data from study participants' electronic medical record will be combined with prospective assessment of their current pain symptoms, quantitative sensory testing, and immune markers, along with patient-reported measures and ambulatory assessments of sleep and rest-activity patterns. Study participants will include adolescents and young adults (ages 14-26) with one of the following conditions - primary MSK chronic pain disorders, inflammatory/autoimmune rheumatic disease with well-controlled disease but ongoing chronic pain, or 3) one-year post-scoliosis or pectus repair surgery with ongoing chronic pain. A group of patients with rheumatic disease or history of prior surgery who have not developed chronic pain will also be assessed as a comparison group.
Unsupervised clustering using the KAy-means for MIxed LArge data (KAMILA) clustering algorithm will be used to identify chronic pain subgroups among participants from an integrated dataset of historical medical data, and prospectively collected data on pain characteristics, sensory testing and cytokine profiles. The optimal number of clusters will be estimated based on the prediction strength method, and the quality of the clustering solutions will be assessed using bootstrapping and other methods.
As a secondary aim, the role of psychological risk and protective factors, behavioral and social determinants on the mechanistically-derived pain subgroups will be examined. A supervised machine learning method will be used with the subgroups as a response variable to determine the contribution of each variable based on its relative importance.
The long-term goal of this research is to precisely identify treatment targets - either pharmacologic agents that act directly on neurobiological systems, behavioral and psychosocial interventions, or a combination of these, to effectively mitigate long-term pain and disability into adulthood.
- Conditions
- Juvenile Idiopathic Arthritis (JIA), Fibromyalgia, Lupus, Scoliosis, Pectus Excavatum, Chronic Pain
- Being tested
- Not applicable- observational study
- Keywords
- Pediatric Pain, Musculoskeletal Pain
- Medical subject headings
- Arthritis, Juvenile, Fibromyalgia, Scoliosis, Funnel Chest, Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
This is an observational study. No intervention is present.
| Study group | Role | What they receive |
|---|---|---|
| Primary musculoskeletal pain disorders | localized or widespread MSK pain Receives: Other: Not applicable- observational study | |
| Inflammatory/autoimmune rheumatic diseases | juvenile idiopathic arthritis (JIA) and childhood-onset systemic lupus erythematosus (cSLE) Receives: Other: Not applicable- observational study | |
| Major MSK surgeries | scoliosis and pectus excavatum repair Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Adolescents and Young Adults in Musculoskeletal Pain Subtypes Identified by Cluster analyses of Clinical, Sensory Testing and Neuroimmune Data
Participants will be assigned to musculoskeletal pain subtypes using unsupervised cluster analysis of integrated data including: (1) medical information (diagnosis, disease duration/severity, treatments); (2) self-reported pain measures (pain intensity [0-10], pain locations, associated symptoms, and pain interference); (3) standardized quantitative sensory testing of pain threshold and responses to mechanical pressure and heat/cold stimuli at the shoulder, forearm, hand, or leg, with pain ratings recorded on a 0-10 scale; and (4) blood biomarkers, including serum cytokine concentrations and cytokine responses from stimulated peripheral blood mononuclear cells measured using a high-sensitivity multiplex panel. Continuous variables will be transformed and standardized as needed. Gower distance and partitioning around medoids will be used to identify pain subtypes. Results will be reported as the number and percentage of participants in each subtype.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07602595
- Sponsor's protocol ID
- IRB #: 2025-0546 BRIDGE Pain
- Other IDs
- UC2AR086503
- Acronym
- BRIDGE Pain
- Status last verified
- May 2026
- First submitted
- 16 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided