Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective...
Acute PainChronic Pain2 moreThis is a clinical trial that intend to determine the effects of S-ketamine on event-related potentials associated with semantic affective pain-processing
PROLONG Prospective, Multi-center, Open-label, Post-market Study
Chronic PainSpinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
Back on Track to Healthy Living Study
Chronic PainChronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Activation Skills (AS). While research has shown these treatments are helpful for people with chronic pain, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with chronic pain in the future. Aim 1, Primary: Researchers will determine how much late-treatment improvement in pain interference related to the study's psychological treatments is predicted by early-treatment changes in the content of negative thoughts about pain (i.e., pain catastrophizing), thought processes (i.e., non-judgment), and/or activity level. Hypothesis 1a: Early treatment changes in pain catastrophizing, non-judgment, and activity level are significantly related with late treatment improvements in pain interference. Hypothesis 1b: If changes in pain catastrophizing, non-judgment, and activity level are mechanisms shared across the three treatments, then the actual treatment condition will have small and non-significant effects on early changes in the mechanism variables. This is known as the Shared Mechanisms Model. Hypothesis 1c: If changes in pain catastrophizing, non-judgment, and activity level are mechanisms specific to CT, MM, and AS, respectively, then treatment condition will have a significant effect on early changes in the mechanism variables (i.e., the effects of the three treatments on the three mechanism variables will be different, with CT having the largest effects on early treatment decreases in catastrophizing, MM having the largest effects on early treatment increases in non-judgment, and AS having the largest effects on early treatment increases in activity level). In addition, later improvement in the primary outcome will be predicted by different mechanism variables as a function of treatment condition; that is, late treatment changes in pain interference will be substantially and uniquely predicted by early treatment changes in: (1) cognitive content (i.e., pain catastrophizing) in CT but not in MM or AS; (2) cognitive process (i.e., non-judgment) in MM but not in CT or AS; and (3) activity level in AS but not in CT or MM, in addition to each mechanism variable significantly predicting the primary outcome. This is known as the Specific Mechanisms Model. Researchers also predict that change in the mechanism variables will precede and predict change in outcome, but not vice versa. Secondary Objective: As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments [Aim 2; Secondary]. The Shared (Hypothesis 2a) and Specific (Hypothesis 2b) Mechanism models will also be applied to data collected via EMA and ActiGraph daily during the 4-weeks post-treatment to better understand the post-treatment mechanisms that underlie maintenance of gains and relapse. Exploratory Objective: Researchers will test if (1) higher baseline levels of catastrophizing are associated with a positive response to the CT intervention, (2) lower baseline levels of activity are associated with a positive response to AS, and (3) higher baseline levels of non-judgment are associated with a positive response to MM.
Strategies to Improve Pain and Enjoy Life
Chronic PainIn the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.
The Sequelae of Mastectomy and Quadrantectomy Respect to the Reaching Movement in Breast Cancer...
Breast CancerPain4 moreThe hypothesis behind our study was that patients after BC surgery, who underwent quadrantectomy or mastectomy, may present a different disability respect to the upper limb on the operated side. Accordingly they could have a different functional recovery patterns after rehabilitation. The aim of our study was to compare the recovery of the fluidity of the reaching movement (Jerk) as the primary outcome, the reduction of shoulder pain and improvement of disability for the upper limb respect the operated side as secondary outcomes, before and after a specific rehabilitation protocol treatment.
Evaluation of the Effects of Virtual Reality in Patients With Chronic Neck Pain
Chronic PainPain1 moreThe main objective of this research is to assess the effectiveness of virtual reality as a treatment to reduce pain and disability in patients with chronic neck pain compared to a regular exercise program for the neck.
The Recovery of Reaching Movement in Breast Cancer Survivors: Two Different Rehabilitative Protocols...
Breast CancerBreast Cancer Lymphedema7 moreThis study emphasizes the importance of rehabilitation in breast cancer survivors after mastectomy, even during the course of radiotherapy and chemotherapy, both for good efficacy in reducing pain and for functional recovery of the upper limb. Authors designed a randomized-controlled trial to compare two different rehabilitation protocols: the single rehabilitative treatment (ST) and the group treatment (GT). The study is the first attempt to measure the reaching movement after BC surgery with an optoelectronic evaluation system previously standardized in the neurological field during rehabilitation treatment.
EaseVRx for the Reduction of Chronic Pain and Opioid Use
Chronic Low-back PainEaseVRx, a software-based virtual reality (VR) medical device, is intended to offer users a prescription pain management tool that manages the symptoms associated with chronic pain and reduces or eliminates the risk of opioid dependence. The investigators will conduct a proof-of-concept randomized study to assess the feasibility and efficacy of using EaseVRx as a 56-day, VR-based, at-home program among 100 chronic low back pain patients by gathering pilot data on the efficacy of the intervention in decreasing pain, reducing opioid/non-opioid pharmacotherapy, and improving pain-related quality of life.
Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
Postoperative PainChronic PainThis is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers. The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
Project Relief: Developing Brain Stimulation as a Treatment for Chronic Pain
Chronic PainChronic Lower Back Pain7 moreEffective 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 largely treated with opiate narcotics, much as was done in the Civil War. In addition to their 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. The proposed study will be the first to employ a randomized, double-blind, sham-controlled design to parametrically evaluate the longitudinal effects of 16 days of Repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex (MC) or the medial prefrontal cortex (MPFC) on self-reported pain and the brain s response to pain. This will be done in a cohort of patients recruited from the community as well as Wake Forest Baptist Health (WFBH) clinics with chronic lower back pain that have not been able to find adequate pain relief, whether or not they are using prescription opiates for 3 or more months. Participants will be randomized to receive rTMS to the MC, MPFC, or sham (50% at each site), using a Latin square randomization. Resting state connectivity will be collected 3 times: before the 1st day of TMS, after the 12th day of TMS, and before the 16th day of TMS (the last day administered).