Investigating Biological Targets, Markers, and Intervention for Chronic Pain

March 24, 2023 updated by: Poppy Schoenberg, Vanderbilt University Medical Center
This multi-modal methods study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of chronic pain, and therapeutic targets using integrative health treatments.

Study Overview

Detailed Description

It is estimated that 50 million adults in the USA suffer from chronic pain. Chronic pain is one of the most common reasons adults seek medical care, causing undue burden on primary care channels and treatment costs. Chronic pain is associated with (1) restrictions in mobility and daily activity, (2) dependence on opioids, (3) anxiety and depression, and (4) poor perceived health and reduced quality of life. Developing robust and specific non-pharmacologic intervention programs, on par with pharmacological clinical outcomes without harmful side-effects, addictive risk, and toxicity, is a crucial unmet clinical need and a research priority for the NCCIH. Understanding the mechanistic pathways of these interventions is key to their clinical development and implementation for treating chronic pain in primary care.

Mindfulness-Based Interventions (MBIs) show similar clinical efficacy for mood disorders as pharmacology, and co-morbid symptoms of depression and anxiety. Meta-analysis including 183 patients with Multiple Sclerosis showed efficacy in psychosocial outcomes, quality of life, anxiety, depression, and select physical symptoms including fatigue, pain, and vestibular symptoms. The clinical efficacy of MBIs appears to extend mood disorders, as a systematic review including 13 studies in fibromyalgia, chronic fatigue, and irritable bowel syndrome showed significant effect sizes, reported as standardized mean difference (SMD), compared to control conditions in reducing symptom severity (SMD= -.40), and pain (SMD= -.21). Cognitively, MBIs appear to enhance executive control and self-regulatory processing, that has a beneficial effect upon emotion regulation, pain perception, and has shown to reduce ruminative ideation. Previous research has also suggested that mindfulness meditation training improves chronic pain symptomology through certain mechanisms such as disengagement from pain-related threats. While previous research has shown MBIs to be effective in treating certain health conditions, the mechanisms by which MBIs lead to clinical changes remain unclear. No study has adequately investigated biological or neurophysiological markers in chronic pain that may correlate with reduction in clinical symptoms.

This overarching study aims to identify key phenotypic markers and treatment targets of chronic pain, and further understand MBI mechanism in its treatment.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for Chronic Pain Patients:

  • 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

Blood Collection Inclusion:

  • 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

Exclusion Criteria for Chronic Pain Patients:

  • 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

Exclusion Criteria for Healthy Controls:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Based Intervention (MBI)
Patients Active Intervention group
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
Other Names:
  • MBI
No Intervention: Wait-list Control (WL)
Patients Control receiving no treatment
No Intervention: Healthy Control (HC)
Healthy Control receiving no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG)
Time Frame: 36 months
Oscillatory Activity
36 months
Electroencephalography (EEG)
Time Frame: 36 months
Event-Related Potentials (ERPs)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endocrine Measures
Time Frame: 36 months
Cortisol, Oxytocin
36 months
Cognitive-Behavioral Measure
Time Frame: 36 months
Executive Inhibitory Control
36 months
Cognitive-Behavioral Measure
Time Frame: 36 months
Working Memory
36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical: Pain Measure
Time Frame: 36 months
McGill Pain Questionnaire; Score range: 0 -- 45, with higher scores indicating worse outcomes.
36 months
Clinical: General Symptoms
Time Frame: 36 months
Patient Reported Outcomes Measurement Information System; Score range: 4 -- 20, with higher scores indicating worse outcomes
36 months
Clinical: Mindfulness Skills
Time Frame: 36 months
Five Facet Mindfulness Questionnaire; 5 domains, Score range: 0 -- 8, with higher scores indicating more mindfulness skills.
36 months
Clinical: Interoception
Time Frame: 36 months
Multidimensional Assessment of Interoceptive Awareness; 8 subdomains, Score range: 0 -- 5, with higher scores indicating more interoceptiveness
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Poppy LA Schoenberg, PhD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2020

Primary Completion (Actual)

July 28, 2022

Study Completion (Actual)

July 28, 2022

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The PI will adhere to the NIH Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.

  1. Quality-controlled raw data as well as processed data used in publications will be de-identified before sharing upon "reasonable request". As described in the proposal, workflows and structure will be exactly described in reports and documented to allow precisely reproduce results from raw data and replicate methodology. Final data (computerized datasets with raw data and derived variables) that have not yet been published will be shared in a timely manner.
  2. Software programs (i.e. experimental paradigm scripts produced for this study) and documentation will be made available for research purposes to replicate findings upon "reasonable request", and any software/script sharing requirements by journals.

IPD Sharing Time Frame

48 months

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Mindfulness Based Intervention

3
Subscribe