Healthy Volunteers Clinical Trial
— COPCOfficial title:
Disrupted Spatial and Temporal Nociceptive Filtering in Adolescents With and Risk for Overlapping Pain Conditions
NCT number | NCT05752396 |
Other study ID # | 2022-0260 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2023 |
Est. completion date | July 1, 2028 |
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
Status | Recruiting |
Enrollment | 420 |
Est. completion date | July 1, 2028 |
Est. primary completion date | July 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Years to 19 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital Medical Center, Cincinnati |
United States,
Coghill RC. The distributed nociceptive system: a novel framework for understanding pain. Scand J Pain. 2022 Sep 22;22(4):679-680. doi: 10.1515/sjpain-2022-0097. Print 2022 Oct 26. — View Citation
Maixner W, Fillingim RB, Williams DA, Smith SB, Slade GD. Overlapping Chronic Pain Conditions: Implications for Diagnosis and Classification. J Pain. 2016 Sep;17(9 Suppl):T93-T107. doi: 10.1016/j.jpain.2016.06.002. — View Citation
Nahman-Averbuch H, Schneider VJ 2nd, Chamberlin LA, Kroon Van Diest AM, Peugh JL, Lee GR, Radhakrishnan R, Hershey AD, Powers SW, Coghill RC, King CD. Identification of neural and psychophysical predictors of headache reduction after cognitive behavioral therapy in adolescents with migraine. Pain. 2021 Feb 1;162(2):372-381. doi: 10.1097/j.pain.0000000000002029. — View Citation
Ohrbach R, Sharma S, Fillingim RB, Greenspan JD, Rosen JD, Slade GD. Clinical Characteristics of Pain Among Five Chronic Overlapping Pain Conditions. J Oral Facial Pain Headache. 2020;34(Suppl):s29-s42. doi: 10.11607/ofph.2573. — View Citation
Quevedo AS, Coghill RC. Attentional modulation of spatial integration of pain: evidence for dynamic spatial tuning. J Neurosci. 2007 Oct 24;27(43):11635-40. doi: 10.1523/JNEUROSCI.3356-07.2007. — View Citation
Quevedo AS, Coghill RC. Filling-in, spatial summation, and radiation of pain: evidence for a neural population code in the nociceptive system. J Neurophysiol. 2009 Dec;102(6):3544-53. doi: 10.1152/jn.91350.2008. Epub 2009 Sep 16. — View Citation
Szikszay TM, Levenez JLM, von Selle J, Adamczyk WM, Luedtke K. Investigation of Correlations Between Pain Modulation Paradigms. Pain Med. 2021 Sep 8;22(9):2028-2036. doi: 10.1093/pm/pnab067. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 3 months, and 12 months | |
Primary | 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. | Baseline, 3 months, and 12 months | |
Primary | 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. | Baseline, 3 months, and 12 months | |
Primary | 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. | Baseline, 3 months, and 12 months | |
Primary | Spatial Summation (SS) Profile | 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. | Baseline, 3 months, and 12 months |
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