Pain Avoidance Behavior and Its Relation to Risk for Opioid Use in Chronic Pain Patients

NCT04603417 | Completed DMC

• 2 other identifiers: 20-0671K01DA050804-01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to find behavioral and neurophysiological correlates of pain avoidance behavior among chronic pain patients, controlling for risk for opioid use disorder. Further, traits and risk factors that contribute to pain avoidance behavior will be investigated. The knowledge gained will broaden the current understanding of mechanisms involved in pain avoidance behavior in chronic pain patients, and help devise novel interventions.

Conditions

Chronic Pain; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Magnetoencephalography (MEG)/Electroencephalography (EEG)

  Brain oscillations during pain avoidance behavior

  year1-5

• Temperament and Character Inventory

  Traits related to pain avoidance behavior

  year1-5

Study Arms (2)

Patients

OTHER

Patients with CRPS diagnosis

Diagnostic Test: Electroencephalography (EEG)/Magnetoencephalography (MEG)/MRI

Controls

OTHER

Healthy controls with known Neurological Disorders

Diagnostic Test: Electroencephalography (EEG)/Magnetoencephalography (MEG)/MRI

Interventions

Electroencephalography (EEG)/Magnetoencephalography (MEG)/MRI DIAGNOSTIC_TEST

This cross-sectional study will present the participants with an instrumental pain avoidance learning task, while we record continuous Magnetoencephalography (MEG) brain signals, and other autonomic measurements. All patients will complete behavioral, neuropsychological and pain assessments to rate their current pain, disability, fear, anxiety, and depression using standardized scales.

Also known as: Behavioral

Controls; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Diagnosis of CRPS I, CRPS II
• Six months or more of medically refractory severe pain
• Average daily pain for the past 30 days reported as ≥ 5 on a 0 - 10 scale
• Presence of allodynia
• Unilateral pain or pain affecting predominantly one extremity. Predominantly will be operationally defined at \>=75 of pain on one extremity.
• Willingness to complete behavioral, clinical and neurophysiological measurement procedures
• Able to provide informed consent
• Able to undergo structural brain MRI

You may not qualify if:

• years and younger
• All other pain diagnosis
• Less than six months or more of medically refractory severe pain
• Average daily pain for the past 30 days reported as \< 5 on a 0 - 10 scale
• Absence of allodynia
• Bilateral pain
• Unwillingness to complete behavioral, clinical and neurophysiological measurement procedures
• Unable to provide informed consent
• Claustrophobic or unable to undergo MRI, MEG or unsafe to undergo MRI (i.e. due to MRI unsafe medical implants).

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

• Roy M, Shohamy D, Daw N, Jepma M, Wimmer GE, Wager TD. Representation of aversive prediction errors in the human periaqueductal gray. Nat Neurosci. 2014 Nov;17(11):1607-12. doi: 10.1038/nn.3832. Epub 2014 Oct 5.

  PMID: 25282614 BACKGROUND

• Gopalakrishnan R, Burgess RC, Malone DA, Lempka SF, Gale JT, Floden DP, Baker KB, Machado AG. Deep brain stimulation of the ventral striatal area for poststroke pain syndrome: a magnetoencephalography study. J Neurophysiol. 2018 Jun 1;119(6):2118-2128. doi: 10.1152/jn.00830.2017. Epub 2018 Jan 31.

  PMID: 29384450 BACKGROUND

• Gopalakrishnan R, Sonneborn C, Baillet S, Machado AG, Wager TD, Roy M. Neurophysiological encoding of aversive prediction errors. Pain. 2025 Jul 16. doi: 10.1097/j.pain.0000000000003712. Online ahead of print.

  PMID: 40668023 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Electroencephalography; Functional Laterality

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Dominance, Cerebral; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hubert Fernandez, MD

  The Cleveland Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Scientist

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 26, 2020
• Study Start: August 15, 2020
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)