242 Clinical Trials for Various Conditions
1. Investigators will determine the feasibility of a virtual reality pain control program (VR-PCP) as a non-pharmacologic adjunct for pain management while in the hospital (i.e. patient ability and willingness to use the system measured by average time spent on the device). 2. Investigators will evaluate if there is a difference between the average daily use of opioid medications taken by patients who received usual care pain management versus patients using a VR-PCP. 3. Investigators will assess for differences in short-term postoperative patient-reported pain intensity (PROMIS Patient Intensity v1.0) for patients who received usual care pain management versus those who also have access to a VR-PCP.
The project is meant to evaluate the effect of a combination of medications (Bupivacaine + Ketamine) used in an ultra-sound guided nerve block for patients presenting to the Emergency Department (ED) with hip and/or femur fractures. The goal is to see whether the combination of these two medications will result in greater and longer-lasting pain relief, longer-lasting motor and sensory block and overall less need for opioid rescue analgesia.
The goal of this pilot study is to determine the feasibility of an individually tailored yoga program delivered in a group setting for the treatment of chronic neck and back pain in a low income population. Chronic pain is one of the most common, costly, and disabling conditions, and is often refractory to treatment. Yoga is a promising treatment for chronic pain. This pilot study will test the hypothesis that study subjects will participate in a voluntary 12 week yoga intervention for the treatment of chronic neck and back pain, as assessed by attendance at 12 weekly yoga practice sessions. Secondary outcomes will include change in pain and quality of life scores over the 12 week study period as assessed by the Visual Analog Scale for Pain Severity and EQ-5D-3L.
Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.
Segmental facilitation, originally proposed by Korr in the 1950s, suggests that certain spinal segments can become hyperexcitable, leading to chronic pain development. In a facilitated segment, neurons governing sensory, motor, and autonomic functions are in a state of heightened sensitivity, making them responsive to normally weak stimuli. Clinical signs include non-fatigable muscle weakness, brisk reflexes, muscle hypertonicity, tenderness upon palpation, and trophic changes like an orange-peel appearance in the affected segment's innervated areas. It's hypothesized that increased synaptic excitability in facilitated segments could cause vasoconstriction and reduced blood flow, contributing to trophic changes and muscle hypertonicity. Manual therapies like dry needling have been shown to alleviate muscle inhibition in the extremities. Previous studies have demonstrated that mobilization of the C5-6 joint can reduce non-fatigable weakness in shoulder external rotators primarily innervated by these segments. However, the neurophysiological effects of dry needling (DN) on muscle inhibition due to a facilitated segment remain unclear. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. Therefore, this project aims to investigate whether DN applied at a facilitated segment could normalize blood flow to its associated muscles. Specifically, this study will explore whether DN at the C5-6 level improves blood flow in the infraspinatus muscle, enhances shoulder range of motion, and influences muscle strength over time. The secondary purpose is to determine whether C5-6 DN will reduce the number of tender points in the muscles supplied by C5-6.
This study will use multiple methods to assess the feasibility of conducting a fully powered multisite clinical trial to test the effectiveness of integrating mindfulness-based interventions into physical therapy for patients with chronic musculoskeletal pain and long-term opioid treatment. First, researchers will develop a manual for training physical therapists to provide mindfulness-based interventions to patients with chronic musculoskeletal pain and long-term opioid treatment. Next, the researchers will evaluate the competency of physical therapists to provided mindfulness-based interventions after being randomized to one of 3 different mindfulness training arms. Patients scheduled for physical therapy with the randomized physical therapists will be invited to enroll in the study. These patients will be asked to complete a variety of patient reported outcomes including self-reported average pain and the the amount of prescription opioid pain medication taken.
The present study involves a randomized clinical trial of Digital Cognitive Behavioral Therapy (dCBT) targeting worry and anxiety symptoms in a population with chronic pain and clinical levels of generalized anxiety disorder (GAD) symptoms. The clinical trial calls for the recruitment and randomization of 80 individuals with chronic musculoskeletal pain and clinical levels of GAD symptoms to either a dCBT program or a waitlist (Control) condition. The current research represents the first-step investigation of a treatment strategy with the potential to enhance care for patients with chronic pain by introducing a scalable, affordable, and system-friendly digital intervention (dCBT) that targets a prominent source of distress and associated disability in these patients. The investigators propose that by targeting GAD in chronic pain in a way that does not tax engagement in ongoing medical care provision, there is the potential to improve the uptake of effective care and to address both GAD and associated distress and disability.
This study examines the efficacy of a brief pre-hospital naloxone education module added to the standard "Total Joint Class" curriculum on patient safety and experience. Participants will consist of 250 patient-and-support-person pairs. The primary outcome is "readiness to use" naloxone - a proxy for opioid overdose safety. Patient factors contributing to this primary outcome as well as the effect on patient attitude and experience will also be investigated.
The purpose of this research study is to evaluate the effect of brief bouts of intermittent walking on bodily pain, pain during movement, and how the body adapts to musculoskeletal pain in older adults.
This study will compare online yoga with Acceptance and Commitment Therapy (ACT), an established treatment for chronic pain. We will compare the efficacy of the two treatments for reducing chronic musculoskeletal pain in veterans.
The goal of this clinical trial is to learn about the use of cannabidiol (CBD) capsules as a treatment for musculoskeletal pain. CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. The main questions it aims to answer are: Is CBD more effective than placebo at relieving pain for upper extremity musculoskeletal pain ? Is CBD safe for participants with upper extremity musculoskeletal pain? Participants will: take 4 weeks of daily CBD capsules take 4 weeks of daily placebo capsules answer surveys about how they are feeling and functioning. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].
This project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (CCBR) training for chronic musculoskeletal pain.
This is a trial to measure the effectiveness and safety of the invisa-RED® IR REHAB device. The researchers will compare the muscle and joint pain relief of participants who are treated with the real machine, to those treated with a non-working "look-a-like" device. If there is a significant difference of pain relief between those treated with the real machine and those treated with the 'look-a-like' device and no safety issues are discovered, the researchers will be able to assume the IR REHAB device is safe and effective for the treatment of muscle and joint pain.
The goal of this randomized control trial is to learn if physical therapy coaching and education improves work-related muscle pain in surgeons more than education alone. The main focuses of this study are to: 1. To evaluate pain in surgeons before and after surgical cases. 2. To evaluate work-load related stress in surgeons after surgical cases. 3. To evaluate surgeons' quality of life. 4. To evaluate surgeons' grip strength. Participants will be put into two groups at random. One group will watch an educational video only. The other group will watch an educational video and get a coaching session from a physical therapist.
The goal of this clinical trial is to learn about resilience coaching in adolescents with chronic musculoskeletal pain. The main questions it aims to answer are to 1) determine how helpful resilience coaching is for teens with chronic musculoskeletal pain, 2) which participants are best suited for resilience coaching, and 3) barriers and facilitators to implementing resilience coaching as part of routine clinical care. Participants will complete survey measures and participate in the resilience coaching intervention called Promoting Resilience in Stress Management (PRISM). Researchers will compare youth in PRISM to those receiving usual care to determine whether PRISM leads to greater improvements in functional disability, psychological distress, and pain intensity than usual care alone.
The goal of this study is to evaluate the effect of intraoperative microbreaks and exercises on gynecologic surgeon body discomfort by conducting a randomized trial. We hypothesize that gynecologic surgeons will experience decreased pain on surgery days with intraoperative microbreaks and exercises without compromising overall surgical performance.
Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and Tai Chi mindfulness intervention can improve physical function in Veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R\&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in Veterans with chronic disease.
In this work the investigators will study the relationship between chronic musculoskeletal pain and abnormal blood flow (neovascularity) around the shoulder, hip and knee. Veterans with as history of chronic shoulder, hip or knee pain and mild/moderate joint degenerative changes will be potential study subjects. Blood flow around joints will be evaluated using perfusion magnetic resonance imaging (MRI). Participants with demonstrably abnormal blood flow around their painful joint will be eligible for enrollment in a pilot study of joint embolization to treat their pain. Participants who choose to not undergo treatment will be re-assessed with MRI after one year to characterize the natural history of joint neovascularity and its relationship to pain.
assess the efficacy of the Signal Relief patch for the management of general musculoskeletal pain
The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.
Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
This project proposes to systematically develop and evaluate the feasibility and preliminary effectiveness of a digitally delivered, graded exposure treatment for youth with chronic musculoskeletal pain, utilizing a sequential replicated and randomized single-case experimental design (SCED). SCED provides the opportunity to rigorously evaluate treatment effectiveness at the individual level. Development of iGET Living will be based on a series of short iterations, with alpha testing (Aim 1) on a small sample of adolescents with chronic pain (N = 15). For Aim 1, participants will participate in three, two hour focus groups (one per week over the course of three weeks), resulting in 6 total hours of participation per participant for Aim 1. Aim 2 will involve a sample (N = 20 youth) of naïve end-users. Participants will be enrolled in a baseline period ranging from 7-25 days (done to support SCED methodology) after which they will be enrolled in the online intervention program, lasting 6-weeks. Patients will be contacted 3-months post-discharge from treatment (week 22 of enrollment) and will complete self-report outcome measures at this time.
The proposed randomized control trial will evaluate auricular point acupressure (APA) treatment administered by the participant themselves with the use of a phone app on chronic musculoskeletal pain (CMP) outcomes. This study will randomly assign participants into three groups: (1) Self-guided mAPA (S-mAPA), (2) In-Person Training + mAPA (IP-mAPA), and (3) Usual Care Control (UC). EMA will be used to assess momentary pain outcomes and APA adherence. Data will be collected at pre- (T1), post-completion of intervention (T2), follow-ups at post 1M- (primary endpoint) (T3), 2M (T4), and 3M (secondary endpoint, long-term sustained effect) (T5) for a total of four assessments.
Acute Pain is one of the most frequent chief complaints and the main reason for visiting the Emergency Department (ED). The acute pain in the ED is largely prevalent across the country with recent literature demonstrating that 61-91% of patients are admitted to the ED due to a variety of acute painful syndromes. There is a lack of good options for pain control in such settings.
This is an Individual Patient Expanded Access IND providing multiple administrations of HBadMSCs for the treatment of Chronic Musculoskeletal Pain. The study duration is approximately 32 weeks, during that time the study subject will complete 1 screening visit, 6 infusion visits, one follow-up visit without infusion and one end of study visit. Next day telephone follow-up visits will occur following each infusion. Efficacy and safety labs as well as quality of life and VAS scores will be obtained.
The purpose of this study is to assess whether a daily, 15-minute stretching routine for one year reduces musculoskeletal pain and improves quality of life in personnel working in the radiology and cardiology departments at Mayo Clinics and Mayo Clinic Health System sites.
An uncontrolled pilot in which Veterans age 60-95 years with chronic musculoskeletal (MSK) pain will undergo Emotional Awareness and Expression Therapy (EAET) delivered over video teleconference (VTC; together vEAET). This study aims to obtain early implementation outcomes, as well as evaluate efficacy and estimated effect sizes.
Acceptance and Commitment Therapy (ACT) has been recognized as an effective, non-pharmacologic treatment for a variety of CP conditions. However, little is known about the neurologic mechanisms underlying ACT. The investigators conducted an ACT intervention in women (n=9) with chronic musculoskeletal pain. Functional magnetic resonance imaging (fMRI) data were collected pre- and post-ACT, and changes in functional connectivity (FC) were measured using Network-Based Statistics (NBS). Behavioral outcomes were measured using validated assessments such as the Acceptance \& Action Questionnaire (AAQ-II), the Chronic Pain Acceptance Questionnaire (CPAQ), the Center for Epidemiologic Studies Depression Scale (CES-D), and the NIH Toolbox Neuro-QoLTM (Quality of Life in Neurological Disorders) scales. Results suggest that, following the four-week ACT intervention, participants exhibited reductions in brain activation within and between key networks including self-reflection (default mode, DMN), emotion (salience, SN), and cognitive control (frontal parietal, FPN). These changes in connectivity strength were correlated with changes in behavioral outcomes including decreased depression and pain interference, and increased participation in social roles. This study is one of the first to demonstrate that improved function across the DMN, SN, and FPN may drive the positive outcomes associated with ACT. This study contributes to the emerging evidence supporting the use of neurophysiological indices to characterize treatment effects of alternative and complementary mind-body therapies.
The purpose of this project is to determine the feasibility, acceptability and effectiveness of acupuncture in the Emergency Department (ED) for treating acute musculoskeletal pain. The overall goal is to reduce acute and subacute opioid use by improving acute pain, anxiety and disability with non-pharmacologic treatment options at a critical entry point for patients into the healthcare system. This full-scale randomized controlled trial (RCT) has been statistically powered to test the effectiveness of ED-based acupuncture for both one-hour (Stage 1) and one-month (Stage 2) pain reduction outcomes. The feasibility will be assessed based on patient recruitment and retention rates, while the acceptability will be assessed using patient reported outcomes and qualitative semi-structured interviews. Stage 1 is a 2-phase study design. Phase (1): Enrolled subjects will be randomized to auricular (ear) acupuncture, peripheral acupuncture, or the control group receiving no acupuncture. Subjects assigned to an acupuncture arm will receive information and access to acupuncture in an outpatient clinic for the 4 weeks following ED visit. Subjects may also have a blood draw for biomarker analysis during their ED visit. A planned interim analysis of the first 60 patients (2/3 of the Phase 1 arm completed) will be completed to select the more effective and/or acceptable arm for Phase 2. At interim analysis, it was determined by the DSMB that neither arm was superior, so the recommendation was to continue Stage 1 Phase 2 unchanged with 3 arms. Stage 1 is complete, and we will proceed with Stage 2 powered to the 4-week pain score outcome. Stage 2 will proceed with the same procedures as stage 1, only powered to a different outcome.
The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.