Recruiting

Observational Study

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT05752396

Conditions

Migraine

Musculoskeletal Pain

Functional Abdominal Pain Disorders

Chronic Pain

Widespread Chronic Pain

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Accepted

Interventions

Conditioned Pain Modulation

Offset Analgesia

Spatial Summation

Temporal Summation

Study Details

Brief 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

Conditions

Migraine

Musculoskeletal Pain

Functional Abdominal Pain Disorders

Chronic Pain

Widespread Chronic Pain

Study ID

NCT05752396

Start date

Mar 1, 2023

Status verified date

Aug, 2024

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 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
2. Control Specific Criteria

  • No history/active chronic pain
3. 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:

1. 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)
2. Control Specific Criteria

  • Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)
3. 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

Study Design

Enrollment

420 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic Pain - Localized

Patients with localized pain conditions (n=140)

Chronic Pain - Overlapping

Patients with two or more pain conditions (n=140)

Healthy Participants

Health Participants without a chronic pain condition (n=140)

Interventions

Conditioned 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.

Offset 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.

Spatial 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.

Temporal 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.

Primary outcome measure

  • Conditioned Pain Modulation (CPM) Profile (Pressure) [ Time Frame: Baseline, 3 months, and 12 months ]
  • Conditioned Pain Modulation (CPM) Profile (Heat) [ Time Frame: Baseline, 3 months, and 12 months ]
  • Offset Analgesia (OA) Profile [ Time Frame: Baseline, 3 months, and 12 months ]
  • Temporal Summation (TS) Profile [ Time Frame: Baseline, 3 months, and 12 months ]
  • Spatial Summation (SS) Profile [ Time Frame: Baseline, 3 months, and 12 months ]

Central Contacts and Locations

Central contacts

Kacie Peters

513-517-0594Kacie.Peters@cchmc.org

Catherine Jackson

513-636-0669Catherine.Jackson@cchmc.org

Locations

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Christopher D King, Ph.D.

513-803-2391christopher.king@cchmc.org

Mary C Hartman, B.S.

5138030411mary.hartman@cchmc.org

Principal Investigator:

Christopher D King, Ph.D.

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Aug 22, 2024

Last verified

Aug, 2024

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 2024-08-22.