Investigating Biological Targets, Markers, and Intervention for Chronic Pain
Condition: Chronic Pain; Pain, Chronic; Pain Syndrome; Pain, Neuropathic; Pain, Intractable
MeSH terms: Neuralgia; Chronic Pain; Pain, Intractable
Study type: Interventional

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.
    

Intervention name(s): Mindfulness Based Intervention
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): MBI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Neurophysiology; Endocrine; EEG/ERP; Cognitive; Mindfulness; Mechanistic Clinical Trial