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356 active trials for Chronic Pain

Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes.

Start: November 2020

Treatment With Radiofrequency in Patients With Chronic Pelvic Pain and History of Endometriosis

Managing chronic pelvic pain in patients with a past history of endometriosis might be a challenge for the gynaecologist. The objective of this study is to evaluate pelvic pain after treatment with radiofrequency in patients with chronic pelvic pain and surgery for endometriosis.

Start: February 2019

Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease

This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

Start: August 2020

Validity and Reliability of the Expectation Scale in the Treatment of Chronic Pain

Questionnaires are available to measure expectations based on patient and treatment expectations in musculoskeletal disorders. In order to elucidate the factors that change expectations in the treatment of pain, more valid and reliable measurement tools are needed to measure the expectations of patients. The validity and reliability made in Turkey, there is no comprehensive study that measures the expectations of treatment. Therefore, the aim of this study was to test the Turkish validity and characteristics of the Chronic Pain Expectations Scale in patients with pain due to chronic musculoskeletal disorders.

Start: October 2020

Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization

Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. Our work aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in our department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). Collaborative Health Outcomes Information Registry uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of duloxetine and desipramine in decreasing pain in patients with chronic pain. The investigators will also compare adherence of patients to these two commonly used medications over a period of six months. This will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in subspecialty clinics. Collaborative Health Outcomes Information Registry can then be applied for numerous future trials to advance our knowledge in perioperative and pain medicine.

Start: September 2018

Virtual Single-Session "Empowered Relief" Group Intervention for Chronic Pain

Pain is naturally aversive and often distressing. Pain coping and self-regulatory skills have been shown to effectively reduce pain-related distress and other symptoms. The purpose of the study is to pilot a single-session videoconference-delivered pain education class (Empowered Relief) for bolstering pain and symptom management in people with chronic pain. Class participants learn skills and develop a personalized plan to use the skills every day. The study will follow participants 3 months by administering 5 follow-up surveys at 1 & 2 weeks and 1 month, 2 months, and 3 months post-treatment to determine whether the class confers long-term benefits across various aspects of health.

Start: September 2020

Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation

Over 100 million Americans suffer from chronic pain resulting in annual cost of roughly $635 billion. Limited treatments are available for this widespread disease. The data supporting these treatments lack generalizability to patients with more serious medical and psychological comorbidities who are often excluded from explanatory efficacy trials. This study aims to integrate randomized comparative effectiveness research with patient care. The investigators will randomize the patients and collect data using an open-source learning healthcare system already in use in the department to monitor patients' progress: Collaborative Health Outcomes Information Registry (CHOIR). CHOIR uses the National Institute of Health Patient Reported Outcomes Measurement Information System item banks for comparative metrics through computer adaptive testing. The investigators will leverage the advantage of this novel system to compare effectiveness of high frequency and burst spinal cord stimulation in improving pain and function in patients with chronic back and/or leg pain. Spinal cord stimulation is an effective treatment for chronic pain resulting in >50% pain relief in about half of the patients. Novel waveforms for spinal cord stimulation - high frequency and burst - increased the efficacy of this treatment even further. However, there is lack of data guiding decision making of the clinicians in choosing the best waveform in treating the patients with chronic pain. The proposed study will provide the clinicians with this evidence. Currently, data about safety and efficacy of these two novel waveforms is available for up to 24 months. The proposed research will provide data about effectiveness of these two modalities for at least 36 months. Moreover, this study will evaluate feasibility of integrating randomized comparative effectiveness research with patient care in Stanford Pain Management subspecialty clinic. CHOIR can then be applied for numerous future trials to advance knowledge in perioperative and pain medicine.

Start: August 2019

Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density

This pilot study is being performed to examine whether epidermal axons are altered in patients taking opioid therapy for chronic non-cancer pain, and if epidermal axonal changes predict heightened pain sensitivity.

Start: December 2020

A Single Arm, Open-label First In Human Study for Assessing the Safety and Performance of the EpiFinder in Subjects With Clinical Indication for Lumbar Epidural Steroids Injection (ESI)

The EpiFinder device, which is the investigational device in this study, is intended for use in epidural procedures, between a luer syringe and an epidural needle, to give the treating physician a clear indication that the needle tip has entered the epidural space. The objective of this First In Human study is to evaluate the safety and performance of using the EpiFinder to identify the epidural space in subjects with a clinical indication to receive a lumbar Epidural Steroid Injections.

Start: December 2019

Pain Catastrophizing and Prescription Opioid Craving

Adherence to prescription opioid and opioid tapering as indicated are critical for safe chronic opioid therapy for chronic pain, but this can be difficult for patients experiencing prescription opioid craving. Because pain catastrophizing is proposed as a possible treatment target by our and others' preliminary results, the proposed study aims to determine whether pain catastrophizing is a treatment target to reduce prescription opioid craving and to investigate whether negative affect and stress hormones are potential mediators. The findings from the current study will inform whether a psychology intervention to lower pain catastrophizing will reduce opioid craving, and whether psychological and physical distress will be potential mediators of the treatment effect.

Start: May 2021

Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain

The investigators will approach elective cardiac and thoracic surgery patients in the preoperative consultation clinic. Consenting individuals will be administered, before surgery validated pain, psychological and sleep questionnaires. These questionnaires will be repeated at 3, 6 and 12 months postoperatively (PO) to follow up the progression of early PO pain and the transition to chronicity. Participants will define clinically relevant pain by calculating a chronic pain index (CPI). In addition, the investigators will follow the development of acute postsurgical and chronic pain from before surgery up to a year after, extract DNA from blood and contrast the genetic variations of participants with clinically significant chronic pain, to identify variations associated with the development of chronic post-surgical pain.

Start: August 2012

Chronic Pain and Transcranial Direct Current Stimulation in Clinical Settings

Physical exercises and transcranial direct current stimulation (tDCS) are both known to reduce chronic pain in structured laboratory studies. The aim of this study is to assess the efficacy of this combined treatment in clinical settings.

Start: January 2021

Marijuana Use, Strength Training, and Alcohol Consumption (MUSTAC) Study

Self-medication of pain by consuming alcohol and marijuana is common. However, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. The study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (DOMS) induction in co-users. This will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.

Start: October 2020

Developing Brain Stimulation as a Treatment for Chronic Pain in Opiate Dependent

Effective control of chronic pain is a top priority in the United States, as approximately 10% of adults have severe chronic pain - most of which is chronic lower back pain (CLBP). However, despite the advances in neuroscience over the past 20 years, chronic pain is still largely treated with opiate narcotics, much as was done in the Civil War. In addition to the high abuse liability and dependence potential, only 30-40% of chronic pain patients declare they receive satisfactory (>50%) relief from their pain through pharmacological treatment. In these patients a common clinical practice is to escalate the dose of opiates as tolerance develops - which unfortunately has contributed to escalation in opiate overdose deaths, a resurgence of intravenous heroin use, and $55 billion in societal costs. Consequently there is a critical need for new, treatments that can treat pain and reduce reliance on opiates in individuals with chronic pain. Aim 1. Evaluate repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: DLPFC TMS will attenuate the baseline brain response to pain (Pain Network activity) and increase activity in the Executive Control Network (ECN) when the patient is given instructions to 'control' the pain. Aim 2. Evaluate Medial Prefrontal Cortex (MPFC) rTMS as a tool to dampen pain and the engagement of the Pain Network. Hypothesis 1: MPFC TMS will also attenuate the baseline brain response to pain (Pain Network activity) but will not effect the ECN or the Salience Network (SN) when the patient is given instructions to 'control' the pain.

Start: February 2019

Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE

COVID infection has resulted in multi-organ injury and may result in cardiovascular, pulmonary, neurological, and muscular damage. It is associated with significant asthenia and the long-term effects of the infection are still unclear, particularly for the development of pain and delayed functional rehabilitation. Glycomics "is the systematic study of the structure of glycans in a given cell type or organism. Glycans are complex oligosaccharides attached to proteins and lipids that regulate a variety of organic processes, including immunity Thus, glycans may influence different moments of the response to the virus and involved in the clinical severity of the disease, but may also change depending on the severity of symptoms and the organic response to SARS-CoV-2 infection. Glycomic data could provide important insights into interindividual differences at the molecular level that directly interact with SARS-CoV-2 and the development of mid- and long-term side effects. The ability to identify early those susceptible to developing COVID-19 infection and at higher risk for COVID-19 with unfavorable outcomes long after infection would help guide therapeutic strategy and provide important guidance for rational health care organization, which is of outmost importance. Long-term outcome data regarding post-COVID patient functional capacity and glycomics will be compared to assess whether there may be differences in protein glycosylation that may predict patient outcome.

Start: March 2021

Mindful Action for Pain

An emerging scientific model that has been applied to chronic pain is the psychological flexibility (PF) model. PF refers to the ability to behave consistently with one's values even in the face of unwanted thoughts, feelings, and bodily sensations such as pain. Acceptance and Commitment Therapy (ACT) is the best known treatment derived from the PF model and is as effective as the gold standard Cognitive Behavioral Therapy (CBT), but falls short on achieving meaningful changes in functional improvement. Although ACT was designed to impact PF, methods from different treatment approaches are also consistent with the model. An experiential strategy that holds promise for enhancing PF is formal mindfulness meditation, a practice used to train non-judgmental awareness and attention to present-moment experiences, which has never been tested within the PF model. There is compelling theoretical and empirical rationale that the mechanisms underlying formal mindfulness meditation will bolster PF processes and thereby can be applied to facilitate functional improvement. To test this, the principal investigator, has developed a novel 8-week group-based intervention, Mindful Action for Pain (MAP), which integrates formal mindfulness meditation with experiential methods from different evidence-based treatment approaches in accordance with the PF model. MAP is designed such that daily mindfulness meditation practice is used to develop the capacity to more completely utilize strategies to address the key psychosocial barriers (e.g., pain catastrophizing) to optimal functioning. This CDA-2 project consists of two phases. Phase 1 (years 1 - 2) consists of using qualitative and quantitative methods to iteratively develop and refine MAP over the course of 4 MAP cycles (n = 20). Phase 2 (years 3 - 5) consists of a pilot RCT (n = 86) of MAP vs. CBT for chronic pain (CBT-CP) in order to establish feasibility of a future large-scale trial and estimate the preliminary impact of MAP. Functional improvement will be measured by reductions in pain interference (primary clinical outcome). Further, meditation adherence will be assessed to explore dose-response relationships with functional improvement, and objective measures of physical activity (actigraphy) will be captured to explore the psychophysical impact of MAP.

Start: August 2019

Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults

The long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults.

Start: March 2021

Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study

This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.

Start: November 2014

Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial

To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the MBAA to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease.

Start: March 2021

Clinical Classification of Pain in Breast Cancer Survivors

Breast cancer is the most common malignancy in women worldwide according to International Agency for Research on Cancer. Unfortunately, cancer survivors often face long-term symptoms that occur or persist after completion of treatment. In addition to fatigue, pain is the most common persistent symptom after cancer and cancer treatment. The diagnosis and treatment of pain in cancer survivors is not clear for many physicians. A mechanism-based classification of pain in cancer survivors might be a critical step for clinical reasoning, especially for discrimination of different pain types. The primary aim of this study is to determine the prevalence of the predominant type of pain in Turkish breast cancer survivors using a recent published clinical algorithm.

Start: January 2020