Funded Projects

Multiple factors, including inflammation contribute to chronic low back pain. Inflammation is mediated by numerous genes. The study aims to determine how variations in the genes encoding key inflammatory mediators impact the response of patients with chronic low back pain to physical therapy treatment. Gene variations that are known to be linked to inflammation and pain will be tested against their possible association on physical therapy treatment outcomes, to inform clinical decisions on optimal care. This study will support training in clinical research on pain within the context of the HEAL BACPAC Mechanistic Research Center. It will provide resources for a research project relevant to the parent grant and the career development of an individual in the field of pain research. The ability to identify a set of genetic variations and classify patients according to treatment response might enable use of DNA testing as a screening tool for targeted treatments for patients with CLBP.

Exacerbation of health disparities has emerged during the COVID 19 pandemic and highlighted the recognition that minority underrepresentation in clinical research may contribute to racial disparities in health outcomes. In clinical trials related to pain, disparities in trial patient inclusion are documented by white patients often being overrepresented. Mitigating these disparities is an area in which an early-career pain investigator training and contributions may have lasting benefits. The pandemic also drove rapid expansion of telehealth for pain management without knowledge of how social and demographic factors affect utilization patterns of this care delivery model. This supplement supports research to examine the extent to which disparities exist in access to and outcomes of telehealth in socially marginalized pain patients. Findings will be applied to enrich the diversity in clinical trial populations for phase 2 safety trials performed in the HEAL EPPIC Network.

Approximately 20% of patients who undergo surgery develop chronic pain, or Chronic Postsurgical Pain (CPSP). CPSP is highly associated with impaired functional recovery and persistent opioid use and dependence, and current standard postoperative multimodal analgesia is only moderately effective for its prevention. This study aims to determine whether the use of ketamine during and/or after surgery prevents Post-Mastectomy Pain Syndrome (PMPS), one of the most common CPSP conditions. Ketamine is a low-risk treatment option that is easy to implement in a wide range of clinical settings. If successful, this treatment could improve postoperative pain management in individuals undergoing mastectomy and help combat the opioid epidemic.

In the US, approximately 100,000 people, mainly of African and Hispanic background have Sickle Cell Disease (SCD). Pain is a constant companion and chronic disabling symptom for those with SCD. It is increasingly clear that adults with chronic SCD pain also experience periods of acute worsening of their pain. The evaluation of nonpharmacological therapies that reduce chronic pain and the need for opioid medication among individuals with SCD is critically needed to address lack of adequate pain control to prevent periods of acute deterioration and high opioid use with negative sequelae. The investigators will conduct a hybrid type 1 effectiveness-implementation trial to assess the effectiveness of acupuncture and guided relaxation in patients with SCD while observing and gathering information on implementation in three health systems. The study will utilize a 3-arm, 3-site pragmatic randomized controlled SMART trial design that evaluates adaptive interventions, in which selection of interventions responds to patients? characteristics and evolving clinical status. The investigators will use the Consolidated Framework for Implementation Research to plan, execute, and evaluate implementation processes.

It is increasingly clear that the microbiome influences psychoneurological symptoms, including pain. This project will support clinical research training focused on examining the relationship between the composition and function of the gut microbiome, including the symbiotic bacteria residing in the gut and their functional gene content, and chronic pain among adults with end-stage kidney disease (ESKD). It provides an opportunity for the trainee to expand his skill set as a pain investigator, through experience in implementing and evaluating pain management interventions in adults with ESKD and chronic pain receiving maintenance hemodialysis. The project aims to determine the acceptability of collecting feces and the feasibility of fecal data collection procedure to determine the best strategies for recruiting research participants from multiple dialysis facilities. These steps will allow the exploration of gene content of the gut microbiota and short-chain fatty acids among people with ESKD on maintenance hemodialysis before and after pain management interventions.

Chronic low back pain is difficult to diagnose and treat effectively in part, because of the interplay of biophysical and psychosocial influences that complicate the relationship between impairment, disability, and pain. Psychological factors such as fear of movement and catastrophyzing can lead to compensatory movement patterns that affect movement biomechanics and paraspinal structure and function, driving further impairment, disrupting the balance between passive and active spine stabilizers, and reinforcing the patient?s perceived disability status. This study will support research to determine how psychological factors, spinal pathology, and perception of pain severity and disability status influence compensatory movement strategies, how movement biomechanics, psychological factors, and pain mechanisms relate to paraspinal muscle quality, and their relative changes during treatment. The supplement will provide training opportunities for skills in clinical pain management research.

The Greater New York Clinical Center (GNYCC) aims to engage experts in pain research and pain practice to build the infrastructure required to support the objectives of the Early Phase Pain Investigation Clinical Network (EPPIC-Net). The GNYCC will provide expertise and resources to perform phase 2 clinical trials to test the efficacy of novel pain treatments, as well as phenotyping and biomarker studies that will enable customized treatments. The consortium comprises four major academic centers in New York City, one of the most diverse cities in the United States and the nation’s largest metropolitan area. We will 1) build infrastructure to rapidly access clinical trial resources and a network of investigators and clinical leaders, 2) develop a plan for swift evaluation and launch of proposed studies, and 3) optimize patient retention and monitor sites to ensure protocol adherence, data quality, and efficiency.

Pain Coping Skills Training (PCST) uses a cognitive behavioral therapy (CBT) approach to teach patients cognitive and behavioral coping skills shown to reduce pain and pain interference (e.g., relaxation, distraction, cognitive restructuring, activity pacing). Randomized controlled trials show that PCST and similar CBT-based interventions, when delivered in a traditional in-person format, can improve pain and functioning in people with cancer and other conditions. Yet these interventions are underused in clinical care due to barriers such as high resource costs, a shortage of therapists trained to deliver them, and travel requirements for patients. This trial aims to deliver evidence-based behavioral pain interventions such as PCST with methods capable of overcoming barriers currently limiting patient access. This will be investigated using a two-arm trial comparing pain relief with the following interventions: painTRAINER in clinic with eight web-based follow-up sessions; enhanced usual care.

Acupuncture has been found to be effective in treating chronic lower back pain (cLBP) in adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently from typical trial participants. To fill this gap, the study team will conduct a three-arm trial of 828 adults ?65 years of age with cLBP to evaluate acupuncture versus usual care. They will compare a standard 12-week course of acupuncture with an enhanced course of acupuncture (12-week standard course, plus 12-week maintenance course) to usual medical care for cLBP. If successful, this pragmatic RCT will offer clear guidance about the value of acupuncture for improving functional status and reducing pain intensity and pain interference for older adults with cLBP.

This study addresses the public health problem of chronic pain as one of the most feared symptoms in people with cancer. Insufficient relief from pharmacological treatments and the fear of side effects are important reasons for the growing use of complementary pain management approaches in people with cancer. One such approach is music therapy. Although efficacy of music therapy for pain has been established, there are no mechanistic studies clarifying how it works in clinical populations. The overarching goals of this study are to 1) examine mediators and moderators hypothesized to account for the pain-reducing effects of interactive music therapy (IMT) in people with advanced cancer and chronic pain and 2) validate IMT’s theory of action. The results of this study will provide estimated effects sizes of IMT on the mediators and preliminary effect size estimates for the pain outcomes. This information will be instrumental in the development of a subsequent large-scale efficacy trial.

This project will examine the association between end plate pathology and chronic low back pain (cLBP) and improve patient selection by developing and translating new imaging tools, technologies, and/or methods (iTTM) that provide accurate, noninvasive measures of end plate pathologies. A search for clinically relevant biomarkers of end plate pathology will focus on novel imaging measures of end plate bone marrow lesion (BML) severity with IDEAL MRI and cartilage endplate (CEP) fibrosis/damage with UTE MRI, assess interactions with paraspinal muscles, and identify metrics that associate with pain, disability, and degeneration. The research will refine imaging and post-processing methodologies by leveraging and expanding existing cross-sectional cohorts and then deploy and validate the new end plate iTTM to other BACPAC sites to test the most promising metrics’ clinical utility. These studies will provide validated iTTM that are useful for addressing the end plates pathology’s role in cLBP, identifying sub-phenotypes, discovering pain mechanisms, uncovering treatment targets, and selecting patients.

Despite the significance of spine disorders, there are few reliable methods to determine appropriate patient care and evaluate intervention effectiveness. The research and tool development take the critical next step in the clinical translation of faster, quantitative magnetic resonance imaging (MR) of patients with lower back pain. The multidisciplinary Technology Research Site (Tech Site) of BACPAC will develop Phase IV (i.e., technology optimization) technologies and/or methods (TTMs) to leverage two key technical advancements: development of machine learning-based, faster MR acquisition methods and machine learning for image segmentation and extraction of objective disease related features from images. The team will develop, validate, and deploy end-to-end deep learning-based technologies (TTMs) for accelerated image reconstruction, tissue segmentation, and detection of spinal degeneration to facilitate automated, robust assessment of structure-function relationships between spine characteristics, neurocognitive pain response, and patient-reported outcomes.