Overlapping Pain Trajectory Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-19
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adolescents with localized and overlapping pain conditions

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Conditioned Pain Modulation

    Other intervention

    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 intervention

    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 intervention

    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 intervention

    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.

Treatment groups

420 Participants
are divided into 3 treatment groups
Group A: Chronic Pain - Localized4 interventions
Group B: Chronic Pain - Overlapping4 interventions
Group C: Healthy Participants4 interventions

Trial outcomes

Primary outcomes

1

Conditioned Pain Modulation (CPM) Profile (Pressure)

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

Time frame
Baseline, 3 months, and 12 months
2

Conditioned Pain Modulation (CPM) Profile (Heat)

-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.

Time frame
Baseline, 3 months, and 12 months
3

Offset Analgesia (OA) Profile

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.

Time frame
Baseline, 3 months, and 12 months
4

Temporal Summation (TS) Profile

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.

Time frame
Baseline, 3 months, and 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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