Overlapping Pain Trajectory Study

NCT05752396 | Recruiting

• 1 other identifier: 2022-0260
• Study Type: observational
• Target: 420
• Locations: 1 country
• Sites: 1

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:

• quantitative sensory testing
• blood draw
• sleep assessment
• questionnaires

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Chronic Pain - Localized

Patients with localized pain conditions (n=140)

Other: Conditioned Pain Modulation; Other: Offset Analgesia; Other: Spatial Summation; Other: Temporal Summation

Chronic Pain - Overlapping

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

Other: Conditioned Pain Modulation; Other: Offset Analgesia; Other: Spatial Summation; Other: Temporal Summation

Healthy Participants

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

Other: Conditioned Pain Modulation; Other: Offset Analgesia; Other: Spatial Summation; Other: Temporal Summation

Interventions

Conditioned Pain Modulation OTHER

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.

Chronic Pain - Localized; Chronic Pain - Overlapping; Healthy Participants

Offset Analgesia OTHER

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.

Chronic Pain - Localized; Chronic Pain - Overlapping; Healthy Participants

Spatial Summation OTHER

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.

Chronic Pain - Localized; Chronic Pain - Overlapping; Healthy Participants

Temporal Summation OTHER

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.

Chronic Pain - Localized; Chronic Pain - Overlapping; Healthy Participants

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents with localized and overlapping pain conditions

You may qualify if:

• 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
• Control Specific Criteria
• No history/active chronic pain
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 36129140 BACKGROUND

• 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.

  PMID: 17959806 BACKGROUND

• 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.

  PMID: 19759320 BACKGROUND

• 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.

  PMID: 32773592 BACKGROUND

• 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.

  PMID: 33587117 BACKGROUND

• 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.

  PMID: 27586833 BACKGROUND

• 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.

  PMID: 32975539 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Musculoskeletal Pain; Chronic Pain; Low Back Pain

Interventions

Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Intervention Hierarchy (Ancestors)

Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Kacie Peters

CONTACT

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

Catherine Jackson

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: March 2, 2023
• Study Start: March 1, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

US (1)