RECRUITING

Overlapping Pain Trajectory Study

Conditions

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

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-03-01

Study Completion:2028-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05752396

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Kacie Peters

CONTACT

513-517-0594

Kacie.Peters@cchmc.org

Catherine Jackson

CONTACT

513-636-0669

Catherine.Jackson@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-01

Study Completion Date2028-07-01

Study Record Updates

Study Start Date2023-03-01

Study Completion Date2028-07-01

Terms related to this study

Additional Relevant MeSH Terms

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