146 Clinical Trials for Various Conditions
1. To show that patients with greater pain sensitivity will show greater improvement in their symptoms (self-reported pain intensity, mood, sleep, and quality of life) than those with lower pain sensitivity, based on QST, after taking milnacipran. 2. To compare outcome differences (pain intensity, mood, activity interference, sleep, and side effects) with those patients who are either taking or not taking opioids for their pain 10 weeks after being prescribed milnacipran. 3. To show that patients who are older, male, with more medical comorbidities, greater disability, and longer pain duration will report less improvement (pain, mood, sleep, health-related quality of life) and treatment satisfaction while taking milnacipran compared with others without such characteristics.
In this SBIR, ALTality, Inc. ("SpellBound") will assess the feasibility of a dual English/Spanish language augmented reality(AR)-enabled tool for assessing inpatient postoperative pain/nausea/vomiting in Hispanic/Latino children and adolescents with cancer in collaboration with bilingual Spanish-speaking anesthesiologists at the MD Anderson Cancer Center. If successful, the AR app will be an immediately implementable and commercially viable method of providing Hispanic/Latino pediatric cancer patients with limited English proficiency an adjunctive tool to overcome infrastructural barriers to receiving translation services in acute care settings that put them at higher risk of under and/or overtreatment of pain by prescription opioids and future prescription opioid dependency and misuse, at no cost to them or their families.
This is an observational study that is intended to determine the capacity of three technologies to serve as diagnostic biomarkers for myofascial pain syndrome. Investigators will seek patients with myofasical pain syndrome as well as healthy subjects for this study. Electrical impedance myography (EIM), myofiber threshold tracking (TT) excitability testing, and ultrasound with shear wave elastography (SWE) measurements will be obtained from the trapezius muscle (the muscle that extends over the back of the neck and shoulders). These measurements will be repeated within 2-5 days to assess repeatability of these methods.
Pain assessments in non-verbal, critically ill infants represent an important clinical challenge. Older children or adults can easily express their pain, but infants lack that capability. They frequently experience repetitive acute pain during routine ICU care, but their analgesic management flounders on the horns of a dilemma: (a) failure to treat infant pain leads to immediate clinical instability and potentially long-term physical, behavioral, and cognitive sequelae, vs. (b) strong analgesics may increase risks for medical complications and/or impaired brain growth. Bedside nurses currently assess pain using pain scores, before taking action to ameliorate pain. Pain scores increase nursing workload and provide subjective assessments, rather than objective data for evaluating infant pain. Consequently, infants exposed to skin-breaking procedures, surgery, or other painful conditions often receive variable and inconsistent pain management in the ICU. The investigators aim to develop a multimodal pain assessment system, using sensor fusion and novel machine learning algorithms to provide an objective measure of pain that is context-dependent and rater-independent. This will enhance the quality of pain management in ICUs and allow continuous pain monitoring in real-time.
To examine pediatric pain assessment in the Emergency Department
Pain assessment in infants and toddlers is quite challenging since children in these populations are nonverbal or preverbal and cannot describe the presence and severity of pain that they perceive. Over the last decade, advances in the field have included the development of behavioral scoring systems for the assessment of acute pain . However, although they have been validated, these commonly used methods of pain assessment are largely subjective and rely on a highly trained observer. An objective continuous measure of pain would be an important addition to standard behavioral painscores which require nurses to monitor the child's behavioral responses.
Pain assessment using self-report scales (Visual Analogue Scale, Numerical Rating Scale), is recommended in the general population, however it is not always possible in patients with altered neurological status such as sedated patients or patients with delirium. Consequently, pain assessment is highly challenging in these ICU patients. This is a prospective observational study assessing 3 behavioral pain scales in the ICU. The hypothesis of this proposal is that one of the three ICU pain scales has a more important reliability than the others. Such a scale could be recommended to be used to measure pain intensity in ICU patients not able to communicate.
Post herpetic neuralgia (PHN) is an undertreated condition. It is a type of neuropathic pain (NP), or pain caused by abnormal activity of sensory nerves. Its mechanisms are not fully understood, and medication trials for PHN pain and other types of NP are frequently unsuccessful. There has been extensive investigation aimed at identifying and understanding the specific mechanisms of NP. While some of these tests are inexpensive and easy to perform at the bedside, many require expensive tools and highly equipped laboratory facilities. Further, there is no standard method for assessment of pain in NP patients. The investigators aim to test a Bedside Sensory Testing Kit (assessment for Neuropathic Pain) on a small number of patients with PHN. The purpose of the Kit is to identify mechanisms of pain. The goal of this research is to design a way to classify patients with PHN based on what mechanisms are causing their pain, since this may help predict the best medications for individual patients.
Heart failure, a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue, yet at least half of persons with heart failure also report the presence of pain. The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence \& Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location, severity and impact on activities and the possible causes of pain in persons living with heart failure. The study will also try to understand relationships between other problems and pain, as well as what treatments are given to reduce pain. Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure.
The purpose of this project is to introduce and implement music therapy as an evidence-based pain management protocol focused on reducing postoperative pain levels among Video-Assisted Thoracoscopic Surgery (VATS) patients in the Post-Anesthesia Care Unit (PACU) of the project site. The clinical question guiding this initiative is: In adult patients undergoing a VATS procedure, does the implementation of music therapy lead to lower postoperative pain scores in the PACU compared to no intervention within an 8-week timeframe? The investigator will ask eligible patients their immediate pain scores upon arrival into the PACU and then start music of patient's choice via over-the-ear headphones. Pain scores will be rechecked 30 minutes after implementation of music therapy. The standard of care pain medications and/or usual care will not be withheld or altered after surgery in lieu of music therapy.
The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.
Negative pressure wound therapy (NPWT) is widely used for chronic and acute wounds, severe burns, and post-operative care. Despite its benefits, the strong adhesive required to maintain an airtight seal increases the risk of medical adhesive-related skin injuries (MARSI), pain, and discomfort during removal. Global Biomedical Technologies (GBT) aims to develop an NPWT drape with "switchable adhesive" technology to enhance removal while maintaining an effective seal. This innovation is expected to benefit both single-use and serial-use NPWT applications by reducing MARSI and improving patient comfort. This project will compare the functionality and acceptability of Comfort Release® NPWT drapes with the industry-standard V.A.C. drape (KCI Technologies, Inc.) in a non-blinded randomized controlled trial. Specific Aims Aim 1: Compare Comfort Release® drapes with V.A.C. drapes in single-use NPWT applications in post-surgical patients (n=200) at Columbia University Medical Center and Weill Cornell Medical Center. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. drapes in: Reduction of MARSI (Medical Adhesive-Related Skin Injury scoring system) Decreased pain (Indiana Polyclinic Combined Pain Scale) Reduced need for pain/anxiety medication Equivalent or improved seal effectiveness (leak incidence rate) Clinician acceptability Aim 2: Compare Comfort Release® drapes with V.A.C. drapes in serial-use NPWT applications in chronic wound patients (n=100) at Weill Cornell Medical Center. Patients will undergo three NPWT drape changes per week. Milestones: Demonstrate statistically significant (α=0.05) improvement over V.A.C. drapes in: Reduction of MARSI Decreased pain (Indiana Polyclinic Combined Pain Scale) Improved compliance with treatment duration Reduced need for pain/anxiety medication Equivalent or better seal effectiveness Clinician acceptability (questionnaire score \>4) Reduced nursing time by ≥20% Economic value through time and cost savings At each dressing change and final removal, qualitative data from clinicians will assess the acceptability and usability of Comfort Release® NPWT drapes.
The purpose of this pilot study is to evaluate effect of IV oxytocin on chronic pain in patients with Hypermobile Ehlers Danlos syndrome.
Pain is common amongst people living with dementia. However, as people's dementia worsens their ability to self-report pain diminishes because of limitations in their cognition and communication abilities. As a result pain in people with moderate to severe dementia often goes under-recognised and undertreated. PainChek® is a technology-enabled, observational pain assessment tool, in the form of a mobile application designed specifically to assist healthcare professionals and professional caregivers assess pain in people with moderate severe dementia. In this study the investigators aim to assess the performance of PainChek® in assessing pain in nursing home residents with moderate to severe dementia compared to the Abbey Pain Scale.
This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent. Eligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission. Eligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants. The study team hypothesizes that: * Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts. * Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.
A double-blind, randomized, placebo-controlled, parallel-group, multi-site, clinical trial to confirm the efficacy and safety of single injection of RTX-GRT7039 versus placebo in patients who have pain associated with osteoarthritis of the knee despite standard of care.
An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.
The purpose of this study is to pilot test a pain assessment information visualization (InfoViz) tool to facilitate communication about pain severity, location, and quality to increase mutual understanding between patients with limited English proficiency (LEP), interpreters, and providers during pain assessment. 40 participants will be enrolled and can expect to be on study for up to 4 weeks.
Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet assessments to identify type, intensity, frequency, and phase of pain among SCD adolescents is lacking. Research shows that interactive gaming technology can enhance adolescents' learning, and can be especially effective in delivering health-related messages and tools to improve their self-care. Pinpoint is an interactive gaming tablet app that will be developed with the significant input of clinical experts to assist SCD teens with better identification and self-report of their pain.
Insufflation pressure (IP) is the creation of a pressure barrier of air/gas within the abdomen to allow the surgeon more space to work during abdominal surgery. Shoulder pain is a common complaint from patients who have had abdominal surgery and the pain is thought to be related to the use of IP. In addition to anesthesia (which keeps you asleep during surgery), the current standard practice is to block the nerve-muscle junction with a type of drug called neuromuscular blockade (NMB) which paralyzes the abdominal muscles. This means that a lower level of insufflation pressure is needed by the surgeon. To reverse the effects of NMB after surgery, a drug called neostigmine is given. The goal of this clinical research study is to compare the use of standard-of-care moderate NMB and neostigmine to the use of deep NMB and a drug called Sugammadex when given to elderly patients (patients who are 65 years of age or older) who are scheduled to have robotic abdominal surgery. "Deep" and "moderate" in this study refers to the dose or strength of the NMB given. This is an investigational study. Sugammadex and neostigmine are FDA approved and commercially available for the reversal of NMB. It is considered investigational to compare Sugammadex and neostigmine to learn if the use of one or the other in elderly patients can reduce the level of shoulder pain after surgery. Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.
The investigators plan to use functional neuroimaging (fMRI) to understand the brain systems affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with fibromyalgia, a chronic pain condition. The investigators will measure the effect of rTMS-augmentation on the brain networks underlying hypnotizability, as well as the effect of rTMS-augmentation on hypnotic analgesia networks. The investigators hope to demonstrate that a combination of these psychological and neuromodulatory treatments will be more effective than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the efficacy of hypnotic analgesia and hopefully creating a new treatment modality for individuals suffering from pain syndromes such as fibromyalgia pain.
The purpose of this study is to determine whether Nitrous Oxide is effective in achieving pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).
The goal of this study is to explore the effects of a Mindfulness Based Couples Intervention on relationship satisfaction with quality of life and immune system function among breast cancer survivors and their partners.
This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen. The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.
The primary objective of this mixed methods pilot study is to understand women's experiences with postplacental intrauterine device (IUD) insertion through postpartum semi-structured interviews. For secondary objectives, the investigators will collect visual analog scale (VAS) and verbal rating score (VRS) data on women's pain experienced just before and immediately after IUD insertion. The investigators will perform postpartum interviews in each group until we reach thematic saturation. The investigators will recruit at least 60 women (30 each in the epidural and no epidural group) from the University of New Mexico Hospital (UNMH) affiliated antenatal clinics to conduct our quantitative data analysis.
The purpose of this project is to test an innovative method for managing pain in acutely ill hospitalized patients who are not able to report their pain verbally to health care professionals. Nurses will use a Pain Assessment and Intervention for the Non-communicative (PAIN) Algorithm to guide assessment of pain, selection of pain medications, and management of medication side effects. The researchers will evaluate whether patients who are managed with the PAIN Algorithm have less severe pain and increased use of pharmacologic pain management strategies than those who are not managed with the PAIN Algorithm. The study design is a non-randomized quasi-experimental cohort design with two cohorts who will be sequentially studied. In phase 1, patients will comprise the usual care group (UCG), or control cohort, defined as receiving pain assessment and management practices that nurses are currently performing on the study units. In phase 2 the PAIN Algorithm coupled with analgesic order sets will be introduced to nurses and physicians on all participating units as the intervention. Patients enrolled in this phase will be considered the intervention group (IG), also called the experimental cohort. Nurses will be enrolled from the participating inpatient units to provide data on the clinical utility of the PAIN Algorithm
The purpose of this study is to compare, the safety, efficacy and level of parent and nurse satisfaction with three methods of opioid administration post-operatively in children (4-18 years of age) with developmental delay.
The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.
The purpose of the study is to improve a questionnaire (the Pain Quality Assessment Scale) used for measuring different types of pain people may experience. An improved version of this questionnaire will help researchers better understand the impact of pain treatments on different types of pain through the use of this questionnaire.
We believe information to be obtained from this proposed study will prove critical for planning future VA healthcare strategies and developing effective and efficient treatments targeting pain and emotional adjustment difficulties among individuals with polytrauma and returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) personnel. More specifically, this study will be the first to provide systematic data regarding pain and emotional problem prevalence, course, associated impairments, risk factors, and barriers to care and community reintegration among returning OEF and OIF service members with and without polytrauma.