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AnalgesiaNCT05487183

Test Retest Reliability of OA and OH

A study testing Medoc cutaneous probe, Quantitative sensory testing and Computer tasks in people with Analgesia and Pain Catastrophizing, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Analgesia, Pain Catastrophizing, Pain
What is being tested?
Medoc cutaneous probe, Quantitative sensory testing and Computer tasks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteUnited States
Study dates
5 Aug 2022to 10 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 18Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Pain Medicine at Centre Commons

    Pittsburgh, Pennsylvania, 15206

Other trials in United States

About this study

Official title: Test Retest Reliability of Offset Analgesia and Onset Hyperalgesia Paradigm

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.

Being tested
Medoc cutaneous probe, Quantitative sensory testing, Computer tasks
Medical subject headings
Agnosia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medoc cutaneous probeBehavioural

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

  • Quantitative sensory testingBehavioural

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

  • Computer tasksBehavioural

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

Study groups in NCT05487183
Study groupRoleWhat they receive
Healthy VolunteersExperimentalQST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes
Receives: Behavioral: Medoc cutaneous probe; Behavioral: Quantitative sensory testing; Behavioral: Computer tasks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Offset analgesia and onset hyperalgesia

    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

    Measured: baseline

  2. Test retest reliability of offset analgesia and onset hyperalgesia

    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

    Measured: 1 week post baseline

  3. Test retest reliability of offset analgesia and onset hyperalgesia

    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

    Measured: 4 weeks post baseline

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

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

    Measured: baseline

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

    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

    Measured: 1 week post baseline

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

    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

    Measured: 4 weeks post baseline

Secondary outcomes (18)

  1. Differences in resting fNIRS signaling

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

    Measured: baseline

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

    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.

    Measured: baseline

  3. Questionnaire score- Pain Catastrophizing Scale (PCS)

    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.

    Measured: baseline

  4. Questionnaire score- STAI Y1 post testing

    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.

    Measured: baseline

  5. Questionnaire score- STAI Y1 post testing

    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.

    Measured: 1 week after baseline

  6. Questionnaire score- STAI Y1 post testing

    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.

    Measured: 4 weeks after baseline

  7. Questionnaire score- Situational Pain Catastrophizing Scale post testing

    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.

    Measured: baseline

  8. Questionnaire score- Situational Pain Catastrophizing Scale post testing

    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.

    Measured: 1 week after baseline

  9. Questionnaire score- Situational Pain Catastrophizing Scale post testing

    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.

    Measured: 4 weeks after baseline

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

    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.

    Measured: baseline

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

    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.

    Measured: baseline

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

    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.

    Measured: baseline

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

    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.

    Measured: baseline

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

    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.

    Measured: 1 week after baseline

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

    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.

    Measured: 4 weeks after baseline

  16. Pain intensity

    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)

    Measured: baseline

  17. Pain intensity

    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)

    Measured: 1 week after baseline

  18. Pain intensity

    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)

    Measured: 4 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start5 Aug 2022
  3. Primary completion10 Apr 2024
  4. Study completion10 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05487183
Sponsor's protocol ID
STUDY22010185
Status last verified
Jun 2024
First submitted
2 Aug 2022
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available, including data dictionaries, after publication per journal and funding protocols. The statistical analysis plan and analytic code will also be available per the same protocols.

Questions about this trial

What is this clinical trial studying?

A study testing Medoc cutaneous probe, Quantitative sensory testing and Computer tasks in people with Analgesia and Pain Catastrophizing, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Offset analgesia and onset hyperalgesia (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05487183.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.

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