Clinical trial NCT05487183: Test Retest Reliability of OA and OH
Official title: Test Retest Reliability of Offset Analgesia and Onset Hyperalgesia Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Pain Catastrophizing
Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Offset analgesia and onset hyperalgesia
timeFrame: baseline
measure: Test retest reliability of offset analgesia and onset hyperalgesia
timeFrame: 1 week post baseline
measure: Test retest reliability of offset analgesia and onset hyperalgesia
timeFrame: 4 weeks post baseline
measure: Differences in brain region activation- QST (quantitative sensory tests)
timeFrame: baseline
measure: Test retest reliability in brain region activation- QST (quantitative sensory tests)
timeFrame: 1 week post baseline
measure: Test retest reliability in brain region activation- QST (quantitative sensory tests)
timeFrame: 4 weeks post baseline
Secondary outcomes:
measure: Differences in resting fNIRS signaling
timeFrame: baseline
measure: Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2
timeFrame: baseline
measure: Questionnaire score- Pain Catastrophizing Scale (PCS)
timeFrame: baseline
measure: Questionnaire score- STAI Y1 post testing
timeFrame: baseline
measure: Questionnaire score- STAI Y1 post testing
timeFrame: 1 week after baseline
measure: Questionnaire score- STAI Y1 post testing
timeFrame: 4 weeks after baseline
measure: Questionnaire score- Situational Pain Catastrophizing Scale post testing
timeFrame: baseline
measure: Questionnaire score- Situational Pain Catastrophizing Scale post testing
timeFrame: 1 week after baseline
measure: Questionnaire score- Situational Pain Catastrophizing Scale post testing
timeFrame: 4 weeks after baseline
measure: Questionnaire score- Beck Depression Inventory-II (BDI-II)
timeFrame: baseline
measure: Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2)
timeFrame: baseline
measure: Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2
timeFrame: baseline
measure: Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
timeFrame: baseline
measure: Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
timeFrame: 1 week after baseline
measure: Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing
timeFrame: 4 weeks after baseline
measure: Pain intensity
timeFrame: baseline
measure: Pain intensity
timeFrame: 1 week after baseline
measure: Pain intensity
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Pain Medicine at Centre Commons
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Benedict Alter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: