Clinical trial NCT04625504: Investigating Biological Targets, Markers, and Intervention for Chronic Pain
Official title: Investigating Biological Targets, Markers, and Intervention for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pain, Chronic
Pain Syndrome
Pain, Neuropathic
Pain, Intractable
Keywords: Neurophysiology
Endocrine
EEG/ERP
Cognitive
Mindfulness
Mechanistic Clinical Trial
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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)

Primary outcomes:
measure: Electroencephalography (EEG)
timeFrame: 36 months
measure: Electroencephalography (EEG)
timeFrame: 36 months
Secondary outcomes:
measure: Endocrine Measures
timeFrame: 36 months
measure: Cognitive-Behavioral Measure
timeFrame: 36 months
measure: Cognitive-Behavioral Measure
timeFrame: 36 months
Other outcomes:
measure: Clinical: Pain Measure
timeFrame: 36 months
measure: Clinical: General Symptoms
timeFrame: 36 months
measure: Clinical: Mindfulness Skills
timeFrame: 36 months
measure: Clinical: Interoception
timeFrame: 36 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Poppy LA Schoenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: