Investigating Biological Targets, Markers, and Intervention for Chronic Pain

Not Applicable

Completed

• Conditions: Pain, Intractable; Pain Syndrome; Pain, Chronic; Pain, Neuropathic; Chronic Pain
• Interventions: Behavioral: Mindfulness Based Intervention

• Registration Number: NCT04625504
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-12
• Study Start: 2020-11-25
• Primary Completion: 2022-07-28
• Study Completion: 2022-07-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Based Intervention (MBI)	Mindfulness Based Intervention	Patients Active Intervention group

Primary Outcome Measures

Name	Time	Method
Electroencephalography (EEG)	36 months	Event-Related Potentials (ERPs)

Secondary Outcome Measures

Name	Time	Method
Cognitive-Behavioral Measure	36 months	Working Memory
Endocrine Measures	36 months	Cortisol, Oxytocin

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States