Test Retest Reliability of OA and OH

Not Applicable

Completed

• Conditions: Analgesia; Pain; Pain Catastrophizing
• Interventions: Behavioral: Medoc cutaneous probe; Behavioral: Quantitative sensory testing; Behavioral: Computer tasks

• Registration Number: NCT05487183
• Lead Sponsor: University of Pittsburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2022-08-05
• Primary Completion: 2024-04-10
• Study Completion: 2024-04-10
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Quantitative sensory testing	QST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes
Healthy Volunteers	Medoc cutaneous probe	QST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes
Healthy Volunteers	Computer tasks	QST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes

Primary Outcome Measures

Name	Time	Method
Test retest reliability of offset analgesia and onset hyperalgesia	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
Differences in brain region activation- QST (quantitative sensory tests)	baseline	Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures.
Offset analgesia and onset hyperalgesia	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
Test retest reliability in brain region activation- QST (quantitative sensory tests)	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 Outcome Measures

Name	Time	Method
Questionnaire score- STAI Y1 post testing	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.
Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2)	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.
Pain intensity	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)
Differences in resting fNIRS signaling	baseline	Differences in fNIRS resting state connectivity as measured by brain region activation
Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2	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.
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing	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.
Questionnaire score- Pain Catastrophizing Scale (PCS)	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.
Questionnaire score- Situational Pain Catastrophizing Scale post testing	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.
Questionnaire score- Beck Depression Inventory-II (BDI-II)	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.
Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2	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.

Trial Locations

Locations (1)

UPMC Pain Medicine at Centre Commons; 🇺🇸 Pittsburgh, Pennsylvania, United States