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Understanding Pain in Adolescents with Chronic Overlapping Pain Conditions

This observational study aims to understand how pain is processed in adolescents (ages 10-19) who experience chronic overlapping pain conditions (COPCs), which are multiple pain conditions at once. Researchers want to see if the way their bodies filter pain signals (spatial and temporal nociceptive filtering) is different compared to young people with single pain conditions or no pain. The study will use several tests, including Conditioned Pain Modulation (CPM), Offset Analgesia (OFA), Spatial Summation (SS), and Temporal Summation (TS), to measure how your body responds to different pain stimuli. The main goal is to see if disrupted pain processing at the start of the study is linked to developing COPCs. The study is currently unclear on its recruitment status and plans to enroll 420 participants.

Study design
This is an observational study, meaning participants will be observed without receiving specific interventions. It aims to enroll 420 participants aged 10-19.
What's involved
Participation includes quantitative sensory testing, a blood draw, a sleep assessment, and completing questionnaires. These assessments will occur at baseline, 3 months, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months, with assessments at baseline, 3 months, and 12 months.

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NCT05752396

Overlapping Pain Trajectory Study

Recruiting
Not specifiedAges 10–19Observational
Children's Hospital Medical Center, Cincinnati
~420 participants
Updated 2024-08-22 on ClinicalTrials.gov
What's tested:Conditioned Pain ModulationOffset AnalgesiaSpatial SummationTemporal Summation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Conditioned Pain Modulation (CPM) Profile (Pressure)
Measured over Baseline, 3 months, and 12 months
+4 more outcomes measured

Conditions

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

Explore related trials

Chronic PainFunctional Abdominal Pain DisordersLower Back PainMigraineMusculoskeletal PainPain Amplification Syndrome

Where it's being run

1 sites across 1 states
Ohio1

Who to contact

Kacie Peters
[email protected]
513-517-0594
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Conditioned Pain Modulation (CPM) Profile (Pressure)Baseline, 3 months, and 12 months

    -CPM is defined by the change in pressure thresholds (increase) before and during cold immersion. Pressure thresholds will be measured using an algometer.

  • Conditioned Pain Modulation (CPM) Profile (Heat)Baseline, 3 months, and 12 months

    -CPM is defined by the change in heat pain intensity (decrease) before and during cold immersion. Heat stimuli will be delivered by a thermode and pain intensity measured by participant self report on the visual analog scale.

  • Offset Analgesia (OA) ProfileBaseline, 3 months, and 12 months

    OFA is defined by the change in heat pain intensity (decrease) after a slight reduction in stimulus intensity (1 Deg C). Heat stimuli will be delivered by a thermode and pain intensity measured continuously during stimuli by participant self report on the computerized visual analog scale.

  • Temporal Summation (TS) ProfileBaseline, 3 months, and 12 months

    TS is defined by the change in mechanical pain intensity (increase) after exposure to a series of pinprick stimuli. Pain intensity will be measured by participant self report on the visual analog scale.

  • Spatial Summation (SS) ProfileBaseline, 3 months, and 12 months

    SS is defined by the change (increase) in heat pain intensity between two simultaneously applied thermodes compared to one stimulus thermode only. Pain intensity will be measured by participant self report on the visual analog scale.