Investigating Biological Targets, Markers, and Intervention for Chronic Pain

NCT ID: NCT04625504

Last Updated: 2023-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2022-07-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Mindfulness Based Intervention (MBI)

Patients Active Intervention group

Group Type: EXPERIMENTAL

Mindfulness Based Intervention

Intervention Type: BEHAVIORAL

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

Wait-list Control (WL)

Patients Control receiving no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Healthy Control (HC)

Healthy Control receiving no treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

MBI

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Poppy Schoenberg

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Poppy LA Schoenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

IRB #201646

Identifier Type: -

Identifier Source: org_study_id