Overlapping Pain Trajectory Study

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05752396
Status
Recruiting

Conditions

  • Chronic Pain
  • Functional Abdominal Pain Disorders
  • Healthy Volunteers
  • Low Back Pain
  • Migraine
  • Musculoskeletal Pain
  • Widespread Chronic Pain

Eligibility Criteria

Sex
ALL
Age
10 Years - 19 Years
Healthy Volunteers
Accepted

Interventions

  • Conditioned Pain Modulation — OTHER
    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.
  • Offset Analgesia — OTHER
    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.
  • Spatial Summation — OTHER
    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.
  • Temporal Summation — OTHER
    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.

Study Details

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

Key Dates

Start date
Mar 1, 2023
Status verified
Aug 2024
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
420 participants (estimated)

Arms

  • Arm: Chronic Pain - Localized
    Patients with localized pain conditions (n=140)
  • Arm: Chronic Pain - Overlapping
    Patients with two or more pain conditions (n=140)
  • Arm: Healthy Participants
    Health Participants without a chronic pain condition (n=140)

Primary Outcome Measure

Conditioned Pain Modulation (CPM) Profile (Pressure) [ Time Frame: Baseline, 3 months, and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's HospitalCincinnatiOhio45229
Christopher D King, Ph.D.
513-803-2391
Mary C Hartman, B.S.
5138030411
Christopher D King, Ph.D. (PRINCIPAL_INVESTIGATOR)

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