RecruitingNCT05752396

Overlapping Pain Trajectory Study

Disrupted Spatial and Temporal Nociceptive Filtering in Adolescents With and Risk for Overlapping Pain Conditions


Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

420 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

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: 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


Eligibility

Min Age: 10 YearsMax Age: 19 Years

Inclusion Criteria9

  • 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 Criteria7

  • 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

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Interventions

OTHERConditioned Pain Modulation

Conditioned pain modulation (CPM) procedure evaluates the change in mechanical and heat pain sensitivity by a contralateral conditioning stimulus (cold immersion). This psychophysical paradigm investigates inhibitory pain modulation processes.

OTHEROffset Analgesia

Offset analgesia (OFA) procedure evaluates the disproportionate change in heat pain sensitivity after a slight decrease in stimulus intensity. This psychophysical paradigm investigates inhibitory pain modulation processes.

OTHERSpatial Summation

Spatial summation (SS) procedure evaluates the change in heat pain sensitivity when applying two painful stimuli simultaneously compared to one stimulus alone. This psychophysical paradigm investigates facilitatory pain modulation processes.

OTHERTemporal Summation

Temporal summation (TS) procedure evaluates the change in mechanical pain sensitivity after exposure to a series of noxious stimuli of the same intensity. This psychophysical paradigm investigates facilitatory pain modulation processes.


Locations(1)

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

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NCT05752396


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