Neurophysiological Assessments for Chronic Pain and Opioid Risk

Overseen By Raghavan Gopalakrishnan, DEng

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Other pain diagnosis, Bilateral pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.

Is it safe to use neurophysiological assessments like EEG, MEG, or MRI for chronic pain and opioid risk evaluation?

The research articles provided do not contain specific safety data regarding the use of EEG, MEG, or MRI for chronic pain and opioid risk evaluation. ^{1 2 3 4 5}

How does the Pain Avoidance Behavior treatment differ from other treatments for chronic pain?

The Pain Avoidance Behavior treatment is unique because it focuses on modifying behavior to manage pain, rather than relying on medications like opioids, which can have significant risks of misuse and addiction. This approach may help reduce the reliance on opioids by addressing the psychological and social factors that contribute to chronic pain. ^{1 3 6 7 8}

What is the purpose of this trial?

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.

Research Team

Hubert Fernandez, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

This trial is for adults with chronic pain, rating their daily pain ≥5 out of 10 for the past month. They must have CRPS I or II, allodynia, and severe pain that hasn't improved after six months of treatment. Participants need to be willing to undergo brain scans and tests, and have mostly one-sided pain.

Inclusion Criteria

You can have a brain MRI scan.

Willingness to complete behavioral, clinical and neurophysiological measurement procedures

My daily pain level has been 5 or more on a scale of 0 to 10 for the past month.

Exclusion Criteria

I have been diagnosed with a condition that causes pain.

My daily pain level has been below 5 for the last month.

I experience pain on both sides of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Initial Assessment

Participants undergo training to understand the task and initial assessments including neuropsychological and pain assessments

1 week

1 visit (in-person)

Experimental Task

Participants perform the instrumental pain avoidance learning task while MEG and other autonomic measurements are recorded

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental task

4 weeks

Treatment Details

Interventions

• Electroencephalography (EEG)/Magnetoencephalography (MEG)/MRI
• Pain Avoidance Behavior

Trial Overview The study uses EEG/MEG/MRI scans to understand how people with chronic pain try to avoid more pain and how this might relate to the risk of opioid addiction. It looks at behaviors, brain activity patterns, traits, and risk factors linked to avoiding pain.

Participant Groups

Group I: Patients Experimental Treatment 1 Intervention

Patients with CRPS diagnosis

Group II: Controls Experimental Treatment 1 Intervention

Healthy controls with known Neurological Disorders

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Baseline reward circuitry activity and trait reward responsiveness predict expression of opioid analgesia in healthy subjects. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Reward Responsiveness in Patients with Opioid Use Disorder on Opioid Agonist Treatment: Role of Comorbid Chronic Pain. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Psycho-physiological response to pain among individuals with comorbid pain and opioid use disorder: Implications for patients with prolonged abstinence. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The risk for problematic opioid use in chronic pain: What can we learn from studies of pain and reward? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Temporal preference in individuals reporting chronic pain: discounting of delayed pain-related and monetary outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Factors mediating pain-related risk for opioid use disorder. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Brain Structure and Function of Chronic Low Back Pain Patients on Long-Term Opioid Analgesic Treatment: A Preliminary Study. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

The Self-administration of Analgesic Drugs in Experimentally Induced Chronic Pain. [2019]