NCT07602595

Brief Summary

The purpose of the study is to discover at least two distinct Musculoskeletal pain subtypes. These types are caused by different brain-and-immune system signals that affect how the body feels pain, and they are also shaped by a person's biology, psychology, and social environment. Aim 1. We want to sort adolescents and young adults with long lasting muscle and bone pain into two different groups. To do this, we will look at participants' childhood medical histories, past treatments, when their pain started, the sex they were assigned at birth, what their pain feels like now, tests of how their body senses pain, and immune system markers found in their blood. We think we will find at least two different types of chronic pain groups, plus one group of patients who had a higher risk for pain (because of a rheumatic disease or past surgery) but never developed long term pain. Aim 2. We want to find out if certain patterns of inflammation in the body change how nerve cells react to pain. Aim 3: We want to understand how different biological, psychological, and social factors are connected to the chronic pain groups we identified. We think we will find certain mental, behavioral, and social risks-as well as protective factors-that help explain why some people develop long-lasting pain and others do not. We expect these factors to play different roles in each pain group, including the group that does not develop chronic pain.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Aug 2026

Typical duration for all trials

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

First Submitted

Initial submission to the registry

May 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

May 16, 2026

Last Update Submit

May 16, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Conditioned Pain Modulation (CPM) Profile (Pressure)

    CPM is defined by the change in pressure thresholds (increase) before and during cold immersion. Pressure thresholds will be measured using an algometer.

    Baseline

  • Conditioned Pain Modulation (CPM) Profile (Heat)

    CPM is defined by the change in heat pain intensity (decrease) before and during cold immersion. Heat stimuli will be delivered by a thermode and pain intensity measured by participant self report on the visual analog scale.

    Baseline

  • Temporal Summation (TS) Profile

    TS is defined by the change in mechanical pain intensity (increase) after exposure to a series of pinprick stimuli. Pain intensity will be measured by participant self report on the visual analog scale.

    Baseline

Study Arms (3)

Primary musculoskeletal pain disorders

localized or widespread MSK pain

Other: Not applicable- observational study

Inflammatory/autoimmune rheumatic diseases

juvenile idiopathic arthritis (JIA) and childhood-onset systemic lupus erythematosus (cSLE)

Other: Not applicable- observational study

Major MSK surgeries

scoliosis and pectus excavatum repair

Other: Not applicable- observational study

Interventions

This is an observational study. No intervention is present.

Inflammatory/autoimmune rheumatic diseasesMajor MSK surgeriesPrimary musculoskeletal pain disorders

Eligibility Criteria

Age14 Years - 26 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Diagnosis of rheumatic/autoimmune disease/pain condition or 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

You may not qualify if:

  • They have active disease, or Other major medical comorbidities have developed after surgery following MSK surgical intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45211, United States

RECRUITING

MeSH Terms

Conditions

Arthritis, JuvenileFibromyalgiaScoliosisFunnel ChestChronic PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesSpinal CurvaturesSpinal DiseasesBone DiseasesBone Diseases, DevelopmentalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Megan Kirschman

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2026

First Posted

May 22, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations