Overlapping Pain Trajectory Study
Recruiting · NCT05752396 · Observational (researchers observe without assigning treatment) · Lead sponsor: Children's Hospital Medical Center, Cincinnati
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls. 2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth. Participation includes: * quantitative sensory testing * blood draw * sleep assessment * questionnaires
Who can take part
Inclusion criteria
- General Criteria
- Access to the internet either by laptop, tablet, or phone (for REDCap Surveys)
- English-speaking
- Parent or guardian willing to comply with protocol, complete study assessments, and provide written informed consent
- Control Specific Criteria
- No history/active chronic pain
- Patient Specific Criteria
- Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), or diffuse MSK (widespread MSK pain)
- If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
Exclusion criteria
- General Criteria
- Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing
- Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes)
- Control Specific Criteria
- Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)
- Patient Specific Criteria
- Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
Where it is running
1 location listed across 1 US state.
- Cincinnati Children's Hospital - Cincinnati, Ohio, United States