Test Retest Reliability of OA and OH

University of Pittsburgh

Status: Completed

Conditions: Pain Catastrophizing; Analgesia; Pain

Treatments: Behavioral: Computer tasks; Behavioral: Medoc cutaneous probe; Behavioral: Quantitative sensory testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05487183

STUDY22010185

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

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

Treatment:

Behavioral: Quantitative sensory testing

Behavioral: Medoc cutaneous probe

Behavioral: Computer tasks