Pain clinical trials at UCSD
21 in progress, 17 open to eligible people
Test the Effects of Kindolor at Different Doses in Healthy Adults
open to eligible people ages 18-55
The goal of this study is to test Kindolor in healthy adults. The main questions it aims to answer are: - What is the safe dose of Kindolor in healthy volunteers? - How is Kindolor metabolized by the human body? Participants will undergo medical tests before and after receiving Kindolor or a placebo to see if there is any difference between the groups.
La Jolla, California
Urinary Polymerase Chain Reaction (PCR) and Next Generation Sequencing (NGS) Technology in the Evaluation and Management of Females With Chronic Bladder Pain and Cystitis-like Symptoms
open to eligible females ages 18-80
Real-world clinical practice multicenter study to determine the clinical implications of employing PCR/NGS technology to identify and treat potential urinary pathogens in female participants identified with bladder pain and/or cystitis-like symptoms.
San Diego, California and other locations
Brain Mechanisms Supporting Cannabis-induced Pain Relief
open to eligible people ages 21-65
The American Academy of Pain Medicine has labeled pain as a "silent epidemic" due to its staggering costs to society (over $500 billion/year) and widespread prevalence (affects over 100 million Americans). Thus, it is imperative to test and validate cost-effective pain therapies. To this extent, cannabis is characterized as one of the most promising therapies to treat a wide spectrum of pain conditions. However, the clinical applicability of cannabis-based pain therapies has been limited due to lacking mechanistic characterization in human-focused studies. Of critical importance, the neural mechanisms supporting cannabis induced pain relief remain unknown. The primary objective of the proposed pilot study is to identify the brain mechanisms supporting the direct alleviation of acutely evoked pain through vaporized cannabis.
La Jolla, California and other locations
Compassion Meditation vs. Health Education for Veterans
open to eligible people ages 18 years and up
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.
San Diego, California
EPPIC-Net: Novaremed Painful Diabetic Peripheral Neuropathy ISA
open to eligible people ages 18 years and up
The purpose of this study is to investigate the safety and efficacy of the current hard gelatin capsule formulation of NRD135S.E1 80 mg once daily in the treatment of PDPN when administered for 13 weeks.
San Diego, California and other locations
EPPIC-Net: Platform Protocol to Assess Treatments for Painful Diabetic Peripheral Neuropathy
open to eligible people ages 18 years and up
This is a Platform Protocol to perform Phase II clinical trials in The Early Phase Pain Investigation Clinical Network (EPPIC-Net), under The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, related to the treatment of Painful Diabetic Peripheral Neuropathy (PDPN) in a platform setting to test multiple assets under a single protocol.
San Diego, California and other locations
Erector Spinae Plane Block Catheters and Intrathecal Morphine for Hepatic Resection
open to eligible people ages 18 years and up
To determine whether the addition of erector spinae plane (ESP) catheters to existing multimodal analgesic regimen with intrathecal morphine provides superior postoperative analgesia in patients undergoing hepatic resection compared with patients not receiving ESP catheters.
San Diego, California
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
open to eligible people ages 18-65
This study aims to look at the long term efficacy of using repetitive transcranial magnetic stimulation (rTMS) in relieving Gulf War Illness related headaches and pain.
San Diego, California and other locations
Managing Opioid Related Sleep Apnea With Acetazolamide
open to eligible people ages 18 years and up
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. However, this device is not effective or tolerated in all individuals. The goal of this study is to examine whether a medication called acetazolamide can improve SDB, as an alternative to CPAP treatment. The investigators will measure the improvement in SDB, as well as any change in symptoms, during a 1 week treatment with acetazolamide compared with 1 week of placebo (sugar pill). This study will help to provide data for longer term studies of treatment for SDB in patients who use opioids.
San Diego, California
Mechanisms of Affective Touch in Chronic Pain
open to eligible people ages 18-65
This study compares how different types of touch found in massage therapies impact pain perception, and whether these effects differ in individuals with and without chronic pain. This study also examines psychological factors that may predict differences in touch perception in individuals with chronic pain. This research will improve our understanding of whether and how massage therapies can benefit pain and health, and whether this differs in people who suffer from chronic pain.
La Jolla, California
CPAP for SDB in Patients Who Use Opioids
open to eligible people ages 18 years and up
Patients with chronic pain who use opioids appear to be at increased risk for breathing issues during sleep, termed sleep disordered breathing (SDB). Treatment of SDB often consists of use of a device during sleep that provides continuous positive airway pressure (CPAP) via a mask interface. The goal of this study is to determine whether patients with chronic pain who use opioids and have SDB might benefit from the use of CPAP in terms of sleep quality, pain, quality of life, and other measures. In addition, the study will examine whether these individuals are able to adhere to CPAP, which will be important for future studies. Lastly, we anticipate that CPAP won't work for everyone due to the changes that opioids can cause in breathing patterns. We will examine how often CPAP is ineffective, and whether we can predict which individuals are least likely to resolve their SDB with CPAP.
San Diego, California
RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain
open to eligible people ages 18 years and up
Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.
San Diego, California and other locations
Repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy
open to all eligible people
Veterans with comorbid chronic pain and depression are highly prevalent, have poor functional status and low quality of life, are at increased risk of suicide and lack access to effective treatments. To address this problem, the proposed research will examine the feasibility of a novel approach that integrates repetitive Transcranial Magnetic Stimulation and Acceptance and Commitment Therapy with the overall goal of maximizing functional improvement in Veterans with chronic pain and depression. This is an important first-step in preparation for a future randomized efficacy trial. The investigators will also include two cognitive control tasks with concurrent electroencephalography to explore as a potential objective indicator of treatment response. This application addresses a critical need within the Veterans Health Administration and is closely aligned with the focus area of developing suicide prevention treatments that influence participation in life roles.
San Diego, California
Predicting Chronic Opioid Use Following Lower Extremity Joint Arthroplasty
open to eligible people ages 18 years and up
Personalized medicine is a concept in which medical care is individualized to a patient based on their unique characteristics, including comorbidities, demographics, genetics, and microbiome. After major surgery, some patients are at increased risk of opioid dependence. By identifying unique genetic and microbiome markers, clinicians may potentially identify individual risk factors for opioid dependence. By identifying these high risk patients early-on, personalized interventions may be applied to these patients in order to reduce the incidence of opioid-dependence.
La Jolla, California
Predicting Chronic Pain Following Breast Surgery
open to eligible people ages 18 years and up
Breast surgery, which includes mastectomy, breast reconstructive surgery, or lumpectomies with sentinel node biopsies, may lead to the development of chronic pain and long-term opioid use. In the era of an opioid crisis, it is important to risk-stratify this surgical population for risk of these outcomes in an effort to personalize pain management. The opioid epidemic in the United States resulted in more than 40,000 deaths in 2016, 40% of which involved prescription opioids. Furthermore, it is estimated that 2 million patients become opioid-dependent after elective, outpatient surgery each year. After major breast surgery, chronic pain has been reported to develop anywhere between 35% - 62% of patients, while about 10% use long-term opioids. Precision medicine is a concept at which medical management is tailored to an individual patient based on a specific patient's characteristics, including social, demographic, medical, genetic, and molecular/cellular data. With a plethora of data specific to millions of patients, the use of artificial intelligence (AI) modalities to analyze big data in order to implement precision medicine is crucial. We propose to prospectively collect rich data from patients undergoing various breast surgeries in order to develop predictive models using AI modalities to predict patients at-risk for chronic pain and opioid use.
La Jolla, California
StimRouter Registry Clinical Protocol
open to eligible people ages 18 years and up
This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
La Jolla, California and other locations
Association of Microbiome Patterns With Chronic Opioid Use
open to eligible people ages 18 years and up
The United States is in the midst of an opioid epidemic, with the number of opioid-related deaths having risen six-fold since 1999. Chronic pain imposes a tremendous economic burden of up to US$635 billion per year in terms of direct costs (such as the costs of treatment) and indirect costs (such as lost productivity and time away from work). We need to better understand individual characteristics that may put patients at risk for chronic opioid use. Recently, the relationship between gut microbiome and diseases of the central and peripheral nervous systems has received increasing attention. New evidence suggests that gut microbiota may also play a critical role in many types of chronic pain, including inflammatory pain, neuropathic pain, and opioid tolerance. Many signaling molecules derived from gut microbiota, such as pathogen-associated molecular patterns, metabolites, and neurotransmitters, act on receptors that regulate the peripheral and central sensitization, which in turn mediate the development of chronic pain. Gut microbiota-derived mediators serve as critical modulators for the induction of peripheral sensitization, directly or indirectly regulating the excitability of primary nociceptive neurons. Given the strong evidence supporting gut microbiome's involvement in pain pathways, there is a need to develop studies that characterize the differences in gut microbiome between chronic pain patients requiring opioids versus healthy controls. The objective of this proposal is to perform a pilot study measuring the predictive ability of the gut microbiome with chronic opioid use - this will then lay the groundwork to adequately power a larger funded prospective study.
La Jolla, California
Acupuncture in the Emergency Department for Pain Management
Sorry, in progress, not accepting new patients
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).
La Jolla, California and other locations
Gabapentin and Tizanidine for Insomnia in Chronic Pain
Sorry, accepting new patients by invitation only
This is a double-blind, placebo-controlled, randomized, crossover trial aimed at assessing the effect of gabapentin and tizanidine, two pain medications, on insomnia in chronic pain patients.
La Jolla, California
Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer
Sorry, currently not accepting new patients, but might later
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.
La Jolla, California and other locations
BEST Trial: Biomarkers for Evaluating Spine Treatments
Sorry, in progress, not accepting new patients
The BEST Trial (Biomarkers for Evaluating Spine Treatments) is a NIAMS-sponsored clinical trial being conducted through the NIH HEAL Initiative's Back Pain Consortium (BACPAC) Research Program. The primary objective of this trial is to inform a precision medicine approach to the treatment of Chronic Low-Back Pain by estimating an algorithm for optimally assigning treatments based on an individual's phenotypic markers and response to treatment. Interventions being evaluated in this trial are: (1) enhanced self-care (ESC), (2) acceptance and commitment therapy (ACT), (3) evidence-based exercise and manual therapy (EBEM), and (4) duloxetine.
San Diego, California and other locations
Our lead scientists for Pain research studies include Anne L Malaktaris Engy T Said, MD Matthew Herbert, PhD Jennifer Anger, MD Rodney Gabriel Nathaniel Schuster, MD Mark Wallace, MD Jeremy Orr, MD Laura K Case, PhD Albert Leung, M.D..
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