Back to results

Investigating Biological Targets, Markers, and Intervention for Chronic Pain

Primary Purpose

Chronic Pain, Pain, Chronic, Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Based Intervention

About this trial

This is an interventional basic science trial for Chronic Pain focused on measuring Neurophysiology, Endocrine, EEG/ERP, Cognitive, Mindfulness, Mechanistic Clinical Trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness Based Intervention (MBI)

Wait-list Control (WL)

Healthy Control (HC)

Arm Description

Patients Active Intervention group

Patients Control receiving no treatment

Healthy Control receiving no treatment

Outcomes

Primary Outcome Measures

Electroencephalography (EEG)

Oscillatory Activity

Electroencephalography (EEG)

Event-Related Potentials (ERPs)

Secondary Outcome Measures

Endocrine Measures

Cortisol, Oxytocin

Cognitive-Behavioral Measure

Executive Inhibitory Control

Cognitive-Behavioral Measure

Working Memory

Full Information

NCT ID

NCT04625504

First Posted

October 29, 2020

Last Updated

March 24, 2023

Sponsor

Vanderbilt University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04625504

Brief Title

Investigating Biological Targets, Markers, and Intervention for Chronic Pain

Official Title

Investigating Biological Targets, Markers, and Intervention for Chronic Pain

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

November 25, 2020 (Actual)

Primary Completion Date

July 28, 2022 (Actual)

Study Completion Date

July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Based Intervention (MBI)

Arm Type

Experimental

Arm Description

Patients Active Intervention group

Arm Title

Wait-list Control (WL)

Arm Type

No Intervention

Arm Description

Patients Control receiving no treatment

Arm Title

Healthy Control (HC)

Arm Type

No Intervention

Arm Description

Healthy Control receiving no treatment

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Based Intervention

Other Intervention Name(s)

MBI

Intervention Description

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

Primary Outcome Measure Information:

Title

Electroencephalography (EEG)

Description

Oscillatory Activity

Time Frame

36 months

Title

Electroencephalography (EEG)

Description

Event-Related Potentials (ERPs)

Time Frame

36 months

Secondary Outcome Measure Information:

Title

Endocrine Measures

Description

Cortisol, Oxytocin

Time Frame

36 months

Title

Cognitive-Behavioral Measure

Description

Executive Inhibitory Control

Time Frame

36 months

Title

Cognitive-Behavioral Measure

Description

Working Memory

Time Frame

36 months

Other Pre-specified Outcome Measures:

Title

Clinical: Pain Measure

Description

McGill Pain Questionnaire; Score range: 0 -- 45, with higher scores indicating worse outcomes.

Time Frame

36 months

Title

Clinical: General Symptoms

Description

Patient Reported Outcomes Measurement Information System; Score range: 4 -- 20, with higher scores indicating worse outcomes

Time Frame

36 months

Title

Clinical: Mindfulness Skills

Description

Five Facet Mindfulness Questionnaire; 5 domains, Score range: 0 -- 8, with higher scores indicating more mindfulness skills.

Time Frame

36 months

Title

Clinical: Interoception

Description

Multidimensional Assessment of Interoceptive Awareness; 8 subdomains, Score range: 0 -- 5, with higher scores indicating more interoceptiveness

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Poppy LA Schoenberg, PhD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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. 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. 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

Learn more about this trial

Investigating Biological Targets, Markers, and Intervention for Chronic Pain

We'll reach out to this number within 24 hrs