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Completed

NCT Number: NCT05487183

Test Retest Reliability of OA and OH

The goal of this study is to measure the test retest reliability of offset analgesia (OA) and onset hyperalgesia (OH) across multiple study visits. OA and OH are quantitative sensory tests (QST) thought to measure how the brain modulates pain. This study will use a heat thermode to induce OA and OH in healthy, pain-free volunteers across 3 study visits. Additional QST measures and survey data relevant to pain modulation will be collected. This study lays the foundation required to use OA and OH as tools to measure pain modulation in clinical trials. Following their validation, we anticipate that OA and OH will serve as predictive and therapeutic biomarkers, which will aid both in the development of novel analgesics and in treatment selection leading to the personalization of pain management.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Catastrophizing Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers with no chronic pain issues who can understand the study procedures

Exclusion criteria

  • History of chronic pain
  • Current significant pain disorder
  • Active ongoing pain every day that is acute or chronic in duration
  • Recent history of migraine (1 attack in last 24 months)
  • Lifetime history mood disorders (anxiety, depression, bipolar) or psychotic disorders.
  • Subjects taking psychotropics (e.g. benzodiazepines, antidepressants), or medications known to affect the autonomic nervous system (e.g. beta-receptor agonists or antagonists) will be excluded.
  • Cognitive impairment affecting the ability to provide informed consent, understand directions, and participate in study procedures
  • Uncontrolled or unstable medical disorder preventing participation in study procedures
  • Pregnancy
  • Tattoos on forearm
  • History of brain surgery
  • Nonambulatory status
  • Heart problems such as an irregular heart beat or coronary artery disease
  • Neurological problems such as seizure, fainting spells, recurrent severe headache, stroke, transient ischemic attack
  • High blood pressure
  • Severe liver disease
  • Severe gastrointestinal disease
  • Chronic severe infectious disease (e.g. HIV/AIDS)

Treatment and study plan

Medoc cutaneous probe

Behavioral

A computer-controlled probe delivers temperatures to the skin to measure pain, OA, and OH

Quantitative Sensory Testing

Behavioral

Standard methods involving pinprick, pressure, heat, and cold applied to the skin are used to measure sensation and pain

Computer Tasks

Behavioral

QST and computer tasks are used to measure changes in pain intensity

Primary outcomes

  1. Offset analgesia and onset hyperalgesia

    Time frame: baseline

    Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline

  2. Test retest reliability of offset analgesia and onset hyperalgesia

    Time frame: 1 week post baseline

    Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 1 week after baseline

  3. Test retest reliability of offset analgesia and onset hyperalgesia

    Time frame: 4 weeks post baseline

    Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 4 weeks after baseline

  4. Differences in brain region activation- QST (quantitative sensory tests)

    Time frame: baseline

    Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures.

  5. Test retest reliability in brain region activation- QST (quantitative sensory tests)

    Time frame: 1 week post baseline

    Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 1 week after baseline

  6. Test retest reliability in brain region activation- QST (quantitative sensory tests)

    Time frame: 4 weeks post baseline

    Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 4 weeks after baseline

Secondary outcomes

  1. Differences in resting fNIRS signaling

    Time frame: baseline

    Differences in fNIRS resting state connectivity as measured by brain region activation

  2. Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2

    Time frame: baseline

    Standardized survey score of state trait anxiety inventory Y1 and Y2 assessing anxiety before QST procedures on visit 1 only.

    State Anxiety Score ranges from 20-80. Trait Anxiety Score ranges from 20-80. Higher scores indicate worse anxiety state and trait symptoms.

  3. Questionnaire score- Pain Catastrophizing Scale (PCS)

    Time frame: baseline

    Standardized survey score assessing pain perception before QST procedures at visit 1 only. Rumination subscale score ranges from 0-16. Magnification subscale score ranges 0-12. Helplessness subscale score ranges from 0-24. Total score can be calculated by summing subscales. Total score ranges from 0-52, with higher scores indicating more pain catastrophizing.

  4. Questionnaire score- STAI Y1 post testing

    Time frame: baseline

    Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state.

  5. Questionnaire score- STAI Y1 post testing

    Time frame: 1 week after baseline

    Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state.

  6. Questionnaire score- STAI Y1 post testing

    Time frame: 4 weeks after baseline

    Standardized survey score of state trait anxiety inventory Y1 assessing anxiety immediately after QST procedures measured at all 3 visits. Higher scores indicate worse anxiety state.

  7. Questionnaire score- Situational Pain Catastrophizing Scale post testing

    Time frame: baseline

    Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit.

    Scores range from 0-24, with higher scores representing more pain catastrophizing.

  8. Questionnaire score- Situational Pain Catastrophizing Scale post testing

    Time frame: 1 week after baseline

    Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit.

    Scores range from 0-24, with higher scores representing more pain catastrophizing.

  9. Questionnaire score- Situational Pain Catastrophizing Scale post testing

    Time frame: 4 weeks after baseline

    Standardized survey score assessing pain perception immediately after QST procedures are completed at each visit.

    Scores range from 0-24, with higher scores representing more pain catastrophizing.

  10. Questionnaire score- Beck Depression Inventory-II (BDI-II)

    Time frame: baseline

    Standardized survey assessing depression at the start of visit 1. Scores range from 0-63. Total score of 0-13 is considered minimal range of depression, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.

  11. Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2)

    Time frame: baseline

    Standardized survey score of GAD-2 assessing anxiety at the start of visit 1. Scores range from 0-6. Higher scores indicate higher likelihood of having GAD.

  12. Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2

    Time frame: baseline

    Standardized survey score of MAIA-2 assessing mindfulness at the start of visit 1. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.

  13. Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing

    Time frame: baseline

    Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.

  14. Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing

    Time frame: 1 week after baseline

    Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.

  15. Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing

    Time frame: 4 weeks after baseline

    Standardized survey score of MAIA-2 assessing mindfulness after QST measured at all 3 visits. Total scores range from 0-160 with 8 subscales. Higher scores indicate higher levels of mindfulness.

  16. Pain intensity

    Time frame: baseline

    Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)

  17. Pain intensity

    Time frame: 1 week after baseline

    Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)

  18. Pain intensity

    Time frame: 4 weeks after baseline

    Changes in pain intensity during quantitative sensory tests and computer tasks measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable)

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Test Retest Reliability of Offset Analgesia and Onset Hyperalgesia Paradigm

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2022
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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