Test Retest Reliability of OA and OH

NCT05487183 | Completed

• 1 other identifier: STUDY22010185
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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

  baseline

• 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

  1 week post baseline

• 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

  4 weeks post baseline

• 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.

  baseline

• 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

  1 week post baseline

• 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

  4 weeks post baseline

Secondary Outcomes (18)

• Differences in resting fNIRS signaling

  baseline

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

  baseline

• Questionnaire score- Pain Catastrophizing Scale (PCS)

  baseline

• Questionnaire score- STAI Y1 post testing

  baseline

• Questionnaire score- STAI Y1 post testing

  1 week after baseline

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

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

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

Interventions

Medoc cutaneous probe BEHAVIORAL

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

Healthy Volunteers

Quantitative sensory testing BEHAVIORAL

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

Healthy Volunteers

Computer tasks BEHAVIORAL

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

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Pain Medicine at Centre Commons

Pittsburgh, Pennsylvania, 15206, United States

Location

MeSH Terms

Conditions

Agnosia; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Benedict Alter, MD, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: August 5, 2022
• Primary Completion: April 10, 2024
• Study Completion: April 10, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available after publication per journal and funding entity protocols.
• Access Criteria: Data will be made available by reasonable request and/or per journal and funding entity protocols.

Locations

US (1)