Pain clinical trials at UCSD

Our goal is to use the R01 mechanism to conduct a two-arm multisite, feasibility RCT (Acupuncture vs Usual Care) to refine procedures for conducting a future fully powered multi-site RCT. The effort will be led by the BraveNet Coordinating Center at Einstein and include 3 BraveNet PBRN sites University Hospitals/ Case Western Reserve University (UH/Case), Vanderbilt University Medical Center (VUMC), and University of California-San Diego (UCSD). During Year 1 (Aim 1), we will develop the manualized acupuncture intervention with consensus from experts in the delivery of acupuncture for acute pain. At the end of Year 1 (prior to the start of the RCT), a study investigator meeting will be held to ensure consistent training of all study coordinators and acupuncturists to the study data collection, human subjects, intervention delivery, and reporting requirements. In Year 2-3 (Aim 2), we will enroll 165 participants (55 per site) into the randomized trial (1:1 assignment to Acupuncture or Usual Care) over a ~9-month enrollment period for each site. Sites will participate in the study sequentially, thus general findings from the implementation evaluation may be used to improve implementation at subsequent sites. Treatment outcomes include pain intensity, state anxiety and pain medication utilization within the ED (via EHR data extraction). In Aim 2a, 75 structured qualitative interviews of ED providers, staff, study acupuncturists (~10 per site) and acupuncture patients (~15 per site) and direct observation at each site will be used to identify barriers and facilitators of successful implementation. The Implementation Evaluation includes two broad categories of data: implementation outcomes (collected in Aim 2 as the feasibility study is conducted at each site) and explanatory factors (Aim 2a).

Chronic pain (CP) is a major health problem for military Veterans, and CP is often associated with comorbid mental health problems, including posttraumatic stress disorder (PTSD) and depression. CP with psychological comorbidity is associated with increased healthcare costs, medication use, risk of suicide and rates of disability and reduced quality of life. Current empirically supported treatments do not always lead to substantial improvements (up to 50% of patients drop out or are do not respond to treatment). This project was designed to evaluate the efficacy of a novel intervention for addressing these challenges. Compassion meditation (CM), a meditative practice that focuses on the wish to remove suffering, is a contemplative practice that has promise for the amelioration of physical and mental health problems as well as promoting positive affect and improving quality of life. This study will evaluate the efficacy of Cognitively-Based Compassion Training for Chronic Pain with Psychological Comorbidity (CBCT-CP+) compared to Health Education while Living with Pain (H.E.L.P.) control condition, in a sample of among Veterans with CP conditions and psychological comorbidity.

The study is a single-center, randomized, participant- and observer-masked, human-subjects, post-market clinical pilot study to investigate the use of ultrasound-guided percutaneous cryoneurolysis to treat diabetic neuropathy of the foot. A prolonged nerve block may be provided by freezing the nerve using a technique called "cryoneurolysis". With cryoneurolysis and ultrasound machines, a small needle-like "probe" may be placed through anesthetized skin and guided to the target nerve to allow freezing. The procedure takes about 6 minutes for each nerve, involves little discomfort, has no systemic side effects, and cannot be misused or become addictive. Participants will be randomly allocated to one of two possible treatments groups: cryoneurolysis (experimental) or sham (control). The primary outcome measure is the change in pain on the neuropathic pain scale from baseline 1 month following the procedure.

The goal of this study is to better understand how two common psychological treatments for pain work in the brain of older adults living with chronic pain. This study will: 1. evaluate fMRI of adults receiving psychological treatments for chronic pain relative to an attention control condition to determine how these interventions work within older adults, and 2. examine self-report and EEG variables to identify for whom do these psychological interventions work. Adults ages 60 years and older, living with chronic pain for at least 3 months will be randomly assigned to one of three conditions: 1. Mindfulness-Meditation 2. Self-Hypnosis 3. Audio Recording Control

This Phase 2 study assesses the safety and efficacy of a single injection of Resiniferatoxin versus placebo for the treatment of intractable advanced cancer pain.