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NCT05752396
Overlapping Pain Trajectory Study
Conditions: Migraine, Musculoskeletal Pain, Functional Abdominal Pain Disorders, Chronic Pain, Widespread Chronic Pain, Low Back Pain, Healthy Volunteers
Sex: All
Ages: 10 Years – 17 Years
Healthy volunteers: 1
Enrollment: 420
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
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:If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls.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 testingblood drawsleep assessmentquestionnaires
Eligibility Criteria
Inclusion Criteria:General CriteriaAccess to the internet either by laptop, tablet, or phone (for REDCap Surveys)English-speakingParent or guardian willing to comply with protocol, complete study assessments, and provide written informed consentControl Specific Criteria• No history/active chronic painPatient Specific CriteriaPatients 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 CriteriaSkin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testingAny 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
Source: ClinicalTrials.gov (NCT05752396). StuddyBuddy aggregates publicly available trial information.