Investigating Biological Targets, Markers, and Intervention for Chronic Pain

NCT04625504 | Completed

• 1 other identifier: IRB #201646
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This multi-modal methods study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of chronic pain, and therapeutic targets using integrative health treatments.

Conditions

Chronic Pain; Pain, Chronic; Pain Syndrome; Pain, Neuropathic; Pain, Intractable

Keywords

Neurophysiology; Endocrine; EEG/ERP; Cognitive; Mindfulness; Mechanistic Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Electroencephalography (EEG)

  Oscillatory Activity

  36 months

• Electroencephalography (EEG)

  Event-Related Potentials (ERPs)

  36 months

Secondary Outcomes (3)

• Endocrine Measures

  36 months

• Cognitive-Behavioral Measure

  36 months

• Cognitive-Behavioral Measure

  36 months

Other Outcomes (4)

• Clinical: Pain Measure

  36 months

• Clinical: General Symptoms

  36 months

• Clinical: Mindfulness Skills

  36 months

Study Arms (3)

Mindfulness Based Intervention (MBI)

EXPERIMENTAL

Patients Active Intervention group

Behavioral: Mindfulness Based Intervention

Wait-list Control (WL)

NO INTERVENTION

Patients Control receiving no treatment

Healthy Control (HC)

NO INTERVENTION

Healthy Control receiving no treatment

Interventions

Mindfulness Based Intervention BEHAVIORAL

Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed

Also known as: MBI

Mindfulness Based Intervention (MBI)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range: 18-60 years
• Must indicate pain intensity of 3/10 and must have experienced pain for at least 3 months
• Must possess English language skills sufficient for providing informed consent, completing questionnaires, and understanding instructions
• Must have a stable medication regimen or no medication or dosage changes within the past month
• At least 110 pounds
• Generally healthy by self-report on day of collection (i.e., free of cold and flu symptoms on the day of collection, no infections within two weeks prior to collection, no known sickle cell disease)
• Including the study draw, blood donation for clinical or research purposes within the preceding eight weeks will not exceed 550 mL
• No more than one blood draw will have occurred during the preceding week

You may not qualify if:

• Prior diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder
• Current history (equal/less than 6 months) of substance abuse/dependence
• Current history (equal/less than 6 months) of regular meditation practice (\>1 session/week; \>10 min/session)
• Diagnosis of bipolar I, bipolar II, psychotic personality disorder, borderline personality disorder, and/or narcissistic personality disorder
• History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes)
• Current suicidal ideation
• Current history (equal/less than 6 months) of substance abuse/dependence
• No major medical illness. History of medical illness associated with possible changes in cerebral tissue or cerebrovasculature (e.g., stroke) or with neurologic abnormality (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, or significant head trauma, defined by loss of consciousness of ≥ 5 minutes)
• Current suicidal ideation
• Current history (equal/less than 6 months) of regular meditation practice (\>1 session/week; \>10 min/session)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Chronic Pain; Somatoform Disorders; Neuralgia; Pain, Intractable

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Poppy LA Schoenberg, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 12, 2020
• Study Start: November 25, 2020
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 48 months

Locations

US (1)