- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04625504
Investigating Biological Targets, Markers, and Intervention for Chronic Pain
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily M Mohr, MA
- Phone Number: 6158754268
- Email: emily.m.mohr@vumc.org
Study Contact Backup
- Name: Poppy LA Schoenberg, PhD
- Phone Number: 6153436991
- Email: poppy.schoenberg@vumc.org
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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
Investigators
- Principal Investigator: Poppy LA Schoenberg, PhD, Vanderbilt University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #201646
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
- 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
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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