Recruiting

Musculoskeletal Pain

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07602595

Conditions

Juvenile Idiopathic Arthritis (JIA)

Fibromyalgia

Lupus

Scoliosis

Pectus Excavatum

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Not accepted

Interventions

Not applicable- observational study

Study Details

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.

Conditions

Juvenile Idiopathic Arthritis (JIA)

Fibromyalgia

Lupus

Scoliosis

Pectus Excavatum

Study ID

NCT07602595

Start date

Aug, 2026

Status verified date

May, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 26

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary musculoskeletal pain disorders

localized or widespread MSK pain

Inflammatory/autoimmune rheumatic diseases

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

Major MSK surgeries

scoliosis and pectus excavatum repair

Interventions

Not applicable- observational study

This is an observational study. No intervention is present.

Primary outcome measure

  • Conditioned Pain Modulation (CPM) Profile (Pressure) [ Time Frame: Baseline ]
  • Conditioned Pain Modulation (CPM) Profile (Heat) [ Time Frame: Baseline ]
  • Temporal Summation (TS) Profile [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45211

Contacts

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

May 22, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-05-22.