An observational study in Juvenile Idiopathic Arthritis (JIA), Fibromyalgia and Lupus, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 1 site in United States. Open to participants aged 14 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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.
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.
365 studies on the registry are indexed under Arthritis, Juvenile; 101 are open to participants now.
This study's planned enrollment of 600 is above the median of 120 across 118 observational studies indexed under Arthritis, Juvenile.
Browse Arthritis, Juvenile studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Oct 16, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
localized or widespread MSK pain
Other: Not applicable- observational study
juvenile idiopathic arthritis (JIA) and childhood-onset systemic lupus erythematosus (cSLE)
Other: Not applicable- observational study
scoliosis and pectus excavatum repair
Other: Not applicable- observational study
This is an observational study. No intervention is present.
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.
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Aug 2029, 34 months later.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 16, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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