Test Retest Reliability of OA and OH

NCT ID: NCT05487183

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2024-04-10

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.

Conditions

Analgesia; Pain Catastrophizing; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

QST devices and computer tasks are used to measure OA, OH, pain intensity, and other outcomes

Group Type: EXPERIMENTAL

Medoc cutaneous probe

Intervention Type: BEHAVIORAL

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

Quantitative sensory testing

Intervention Type: BEHAVIORAL

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

Computer tasks

Intervention Type: BEHAVIORAL

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

Interventions

Medoc cutaneous probe

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

Intervention Type: BEHAVIORAL

Quantitative sensory testing

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

Intervention Type: BEHAVIORAL

Computer tasks

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Benedict Alter

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benedict Alter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY22010185

Identifier Type: -

Identifier Source: org_study_id