Investigating Biological Targets, Markers, and Intervention for Chronic Pain

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04625504

Collaborator

(none)

160

Enrollment

Location

Arms

35.5

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain Pain, Chronic Pain Syndrome Pain, Neuropathic Pain, Intractable	Behavioral: Mindfulness Based Intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Investigating Biological Targets, Markers, and Intervention for Chronic Pain

Actual Study Start Date :

Nov 25, 2020

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Nov 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Based Intervention (MBI) Patients Active Intervention group	Behavioral: Mindfulness Based Intervention 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

Arm

Intervention/Treatment

Experimental: Mindfulness Based Intervention (MBI)

Patients Active Intervention group

Behavioral: Mindfulness Based Intervention

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

Outcome Measures

Primary Outcome Measures

Electroencephalography (EEG) [36 months]
Oscillatory Activity
Electroencephalography (EEG) [36 months]
Event-Related Potentials (ERPs)

Secondary Outcome Measures

Endocrine Measures [36 months]
Cortisol, Oxytocin
Cognitive-Behavioral Measure [36 months]
Executive Inhibitory Control
Cognitive-Behavioral Measure [36 months]
Working Memory

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)