159 Clinical Trials for Various Conditions
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.
The purpose of this study is to evaluate whether intramuscular injections of VM202 into the calf is safe and effective in the treatment of critical limb ischemia.
Objectives: The purpose of this study was to determine whether tenderness and other commonly used chiropractic measures, when operationalized, improve after lumbar chiropractic manipulative therapy (CMT) in patients with lower back and/or leg pain. A secondary aim was to determine whether changes in tenderness as measured using algometry, correlate with other commonly used measures before and after care.
After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The proposed work will contrast the efficacy of two virtual reality treatments for phantom limb pain: a 'Distractor' and an Active VR treatment. In the Distractor treatment, participants are engaged in a visually immersive virtual reality experience that does not require leg movements (REAL i-Series® immersive VR experience). In the Active VR treatment, subjects play a series of VR games using the virtual rendering of both legs.
Guidelines advocate several complementary modalities as alternatives to drugs and other invasive treatments for chronic low back pain (LBP) conditions. However, there is little high-quality research investigating treatments for back-related leg pain, one of the more severe and disabling presentations of LBP. The investigators are conducting a pilot study to assess the feasibility of a future phase II multi-site randomized clinical trial (RCT). The future trial will assess the comparative effectiveness of a novel supported biopsychosocial self-management (SBSM) intervention versus Medical Care (MC).
To evaluate the safety and effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities compared to Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain who have not undergone spinal surgery when using the Boston Scientific WaveWriter SCS Systems.
Aging of the back is common in the older people and can result in difficulties standing and walking. Conservative treatment is recommended before considering surgery. Some recommended exercises involve the use of expensive equipment. The present study plans to evaluate if specifically moving the nerves in the legs/back and improving flexibility of the hip and back can benefit patients. These exercises require no equipment, are simple to perform, and can provide patients a way to continue to perform these exercises at home. The purposes of this study are to (1) observe the benefit of a treatment program involving moving the nerves of the leg/back, stretching the legs and low back in patients with low back pain and difficulties walking; and (2) determine if benefits received remain at a 3-month follow-up.
The objective of the study is to demonstrate that treatment with Apligraf reduces venous leg ulcer (VLU)-related pain and improves the quality of life (QOL) of patients with a painful VLU.
Peripheral arterial disease (PAD) is a disorder that affects more than 8 million people in the United States. As a result of decreased blood flow to the legs, people with PAD may experience leg pain and difficulty with walking. This study will examine the effectiveness of two exercise programs-a treadmill walking program and an aerobic arm exercise program-at increasing walking distance and decreasing leg pain in people with PAD.
The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.
1. Research question: Does vitamin D reduce the frequency and severity of nocturnal leg cramps in older persons who previously took quinine for leg cramps? 2. Experimental Design: This is a randomized, double blind, placebo controlled study of 70 men and women veterans receiving care at the Madison VA Medical Center(VAMC) or at the University of Wisconsin Hospitals and Clinics (UWHC). Individuals age 50 or more who have previously taken quinine for nocturnal leg cramps and meeting baseline criteria are eligible to enroll. Enrollees meeting laboratory criteria, including low-normal vitamin D levels, will undergo a 2-week "diary run-in" period to confirm cramp frequency. Those who report two or more leg cramps in each week will continue in the study and will be randomized to vitamin D or placebo. After a two-week wash-in, subjects will take a vitamin D capsule (50,000 units) once daily for 10 days, followed by a once weekly vitamin D (50,000 units) maintenance dose for 7 weeks. Subjects will record by diary the number and severity of leg cramps from the start of the "diary run-in" until a week after the last dose of study drug. Study investigators will call subjects at scheduled intervals to assess compliance, tolerability, and diary use. 3. Major risks to subjects: No major risks are anticipated. Excessive vitamin D can increase blood calcium levels (hypercalcemia), with symptoms such as thirst, nausea, and weakness. However, symptomatic hypercalcemia has not been reported except for those taking more than 40,000 units daily for several months. This is far above the cumulative dose in our study. 4. Potential benefits: Subjects may not receive any benefit. Vitamin D may alleviate leg cramps for subjects who receive it. 5. Consent Procedure: Flyers describing the study and telephone contact information will be mailed to patients who have received quinine during the period 2002-2007. The PI or Co-PI will return calls to describe the study and answer any questions. For persons meeting preliminary (pre-lab) study criteria, two copies of the consent form will be mailed, with the patient mailing back one signed consent to the PI.
The primary aims of the project are to determine the clinical efficacy of chiropractic Spinal Manipulative Therapy (SMT) plus self-care education versus self-care education alone in 192 patients with sub-acute and chronic Back Related Leg Pain (BRLP) in both the short-term (after 12 weeks) and long-term (after 52 weeks). The primary outcome variable is leg pain and secondary outcome variables include low back pain, disability, bothersomeness and frequency of symptoms, general health status, and fear avoidance behavior. Secondary aims are to describe and estimate between group differences in patient satisfaction, improvement, medication use, straight leg raise, torso endurance, and three biomechanical measures: continuous spinal motion, postural sway, and neuromuscular response to sudden load. Patient perceptions of treatment will also be assessed.
The primary objective of this study is to identify the brain regions in which activity is affected by SCS. Baseline cerebral blood flow scans with the device turned off will be generated compared to scans produced with the device operating at parameters which produce optimal coverage of the painful areas. The relationship between cerebral blood flow and pain rating scores will be evaluated in both conditions.
The goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). Stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking. This study is a double-blind, randomized study to compare CD34-positive stem cells versus a placebo agent (salt water solution known as normal saline). The patient will have a 3:1 chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.
The purpose of this study is to apply Anodyne therapy to active duty soldiers, who have shin splints, to evaluate healing time and effectiveness.
Hypothesis - This study is designed to evaluate the results of using the Orthotrac Pneumatic Vest versus an EZ form brace in patients with radiating leg pain from disc bulge / protrusion / herniation. Specifically, our hypothesis is that patients given the Orthotrac Pneumatic Vest (OPV) will have greater pain relief and increased self-reported functionality and fewer progressions to surgery than those using the EZ form brace.
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
The main purpose of this study is to establish the extent that chronic pain patients implanted with surgical, laminectomy-type, leads experience position-related variation in spinal cord stimulation therapy and to investigate the effects of manual versus automatic position-adaptive spinal cord stimulation on clinical outcome.
The purpose of this study is to determine the incidence of pegfilgrastim-induced back and leg pain and to determine whether the antihistamine loratadine can prevent pegfilgrastim-induced back and leg pain.
The purpose of this study is to characterize a patient's activity levels before and after spinal cord stimulation therapy.
The purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
To improve the safety of diagnosis and therapy for a set of conditions and undifferentiated symptoms for hospitalized patients, the investigators will employ a set of methods and tools from the disciplines of systems engineering, human factors, quality improvement,and data analytics to thoroughly analyze the problem, design and develop potential solutions that leverage existing current technological infrastructure, and implement and evaluate the final interventions. The investigators will engage the interdisciplinary care team and patient (or their caregivers) to ensure treatment trajectories match the anticipated course for working diagnoses (or symptoms), and whether they are in line with patient and clinician expectations. The investigators will use an Interrupted time series (ITS) design to assess impact on diagnostic errors that lead to patient harm. The investigators will perform quantitative and qualitative evaluations using implementation science principles to understand if the interventions worked, and why or why not.
A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study stimulation testing following the conclusion of a successful SCS commercial trial.
Spinal Cord Stimulation (SCS) uses electrical signals to disrupt noxious signals arising from painful areas, thereby reducing pain perception. Successful SCS implants lead to a broad range of positive outcomes: 1) long-term pain can be expected to be reduced by at least by 50%; 2) quality of life as assessed by subjective measurements improves substantially; 3) patients can significantly reduce opioid medication intake.1 However, the impacts of SCS intervention on neuromuscular and biomechanical outcomes including gait and balance have not been fully explored. Fifty subjects with symptomatic leg pain and/or low back pain (LBP) who are deemed appropriate SCS candidates and are scheduled for surgery will undergo gait and balance analyses preoperatively as well as 6 weeks and 3 months post operatively. In addition, 50 control subjects having no pain will undergo 1 session of gait and balance assessment. Objective spine and lower extremity motion and neuromuscular control will be evaluated using dynamic surface EMG and a video motion capture system during functional evaluation. Also, explored will be the relationship of changes in gait and balance to psychosocial factors that have previously been shown to be correlated with SCS outcomes.
This study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by SCS.
To explore the optimal stimulation parameters and locations for sub-perception programming in patients with previously implanted spinal cord stimulation systems for the treatment of chronic back and/or leg pain.
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering from predominant low back pain due to failed back surgery syndrome (FBSS).
The overall objective of this study is to assess patterns of fMRI cortical activation with spinal cord stimulation (SCS) in patients with neuropathic leg pain and therefore define cortical correlates, as well as to investigate cortical representations of pain and pain relief and the interactions therein, in the setting of neuropathic leg pain and SCS.
This study is being undertaken to compare the clinical outcomes of patients that have unilateral posterolateral lumbar interbody fusion using a traditional open approach versus the MiLIF procedure based on the MiCOR Precision Bone Allograft, specialized Atavi instrumentation, and minimally invasive visualization capabilities.