101 Clinical Trials for Various Conditions
This study is designed to evaluate the effectiveness of a proprietary nutritional supplement that contains Krill Oil (KO), astaxanthin (AX) and hyaluronic acid (HA) to reduce pain and discomfort in participants, compared to an inert placebo (palm oil) control and to a positive control (glucosamine-chondroitin). The purpose of the study is to determine if the combination of KO, AX, and HA will benefit participants with joint pain.
This study involves imaging the skin movements of surface tissue on the back. A clinician will perform assessment and intervention procedures manually, using manual and light movements of stretch and compression.
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.
This study will use microdialysis to investigate myofascial pain. This pain is characterized by "trigger points" (exquisitely tender spots) in a group of tense muscle fibers that extend from the trigger point to the muscle attachments. Trigger points in the trapezius, a large muscle lying between the neck and shoulder, are typically caused by emotional stress, postures such as hunching shoulders, certain activities like using a telephone receiver without elbow support, or by wearing certain articles such as a heavy coat or heavy purse. Microdialysis uses a very thin needle probe (about the size and shape of an acupuncture needle) to collect and measure chemicals directly from soft tissue. Analysis of these chemicals will show whether changes in the tissue around a muscle with trigger points are confined to that muscle, or if these changes also occur in more distant muscles. The study will examine two types of trigger points. An "active" trigger point causes pain or other abnormal symptoms and often causes problems with movement. A "latent" trigger point often causes movement problems without causing pain. Many healthy adults have latent trigger points. People between 21 and 65 years of age with the following characteristics may be eligible for this study: 1) no neck pain or trigger points in either upper trapezius muscle; 2) no neck pain but a latent trigger point in at least one upper trapezius muscle; or 3) neck pain of less than 3 months' duration and an active trigger point in at least one upper trapezius muscle. Participants undergo the following procedures: * Physical examination of the muscles of the neck and shoulder area, testing strength and range of motion, and response to palpation to find trigger points. * Pain inventory. Subjects complete a questionnaire for measuring pain and its intensity, location, quality, causes, relievers, and associated symptoms. The questionnaire is filled in before and after each microdialysis procedure. * Microdialysis in upper trapezius muscle. An electrode patch is placed on either side of the site for insertion of the microdialysis probe and another electrode is placed on the outer edge of the shoulder. The electrodes are used to measure any electrical activity that occurs with insertion or movement of the probe. The subject lies face down and the probe is inserted in the upper trapezius muscle. It remains in place for 5 minutes while chemical substances are collected from the muscle. It is then advanced about 1.5 cm deeper into the muscle until a twitch response is obtained and remains in place for 10 more minutes while substances are collected. * Microdialysis in the gastrocnemius muscle (large muscle of the calf). The same procedure for the upper trapezius muscle is done in the calf muscle.
Lipedema is an inflammatory and painful disease of subcutaneous adipose tissue (SAT) in women that is associated with vein disease and lymphedema. There is controversy on whether there is edema in lipedema. This study seeks to determine: 1. Is there is edema in lipedema? 2. Can edema, lipedema subcutaneous adipose tissue (SAT), symptoms, and quality of life be improved by an advanced intermittent pneumatic compression device (IPCD)? During the course of the study subjects will be seen three times in the clinic for assessment and measurements. All subjects will be provided a compression legging at the first clinic visit. Half of the subjects (the treatment group) will be provided and use an advanced intermittent pneumatic compression device with pants-type appliance that applies dynamic compression therapy to the abdomen, hips, buttocks, legs and feet, starting at the second visit, for 30 days at home, along with daytime use of the compression legging. The other half (the control group) will use the compression leggings only. At the third visit, final measurements will be obtained. The measurements in the study include volume measurements using tape measure and a scanner; body composition measurements (bioimpedance); ultrasound and biopsy of the skin; timed walking and gait measurements; and questionnaires about pain and quality of life. Deidentified (without names) patient medical records will be examined for information on vein disease, body mass index, weight, age, and stage of lipedema (any stage or type). After the third visit, results will be analyzed.
The purpose of the current investigation is to examine the effect of tissue-flossing on upper extremity, pain, strength and functional performance in subjects with musculoskeletal-related complaints of pain surrounding the elbow complex
The purpose of this study is to compare the effectiveness of standard medical therapy versus usual care in women with chest pain, coronary endothelial dysfunction and unblocked coronary arteries. Coronary endothelial dysfunction (CED) is a condition in which the layers of cells around the heart do not function properly and is believed to be key factor in the development of atherosclerosis (fat deposits in arteries). In addition, CED is associated with an increased risk for future cardiovascular events, such as heart attack and stroke. A coronary angiogram allows physicians to see if any of the arteries in the heart are blocked, usually by fatty plaque. In many instances, angiograms in women experiencing chest pain do not show evidence of coronary disease (free of significant plaque build-up). Currently, there is no standard of care treatment plan for patients with normal coronary arteries, despite symptoms of chest pain, and as a result these patients may not receive medical treatment. However, these women often return to their physicians more than once with chest pain and go through a similar battery of tests.
The purpose of this study is to study if lidocaine, given intravenously, reduces pain.
Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). The technique involves inserting a probe, guided by computed tomography or ultrasound, and sending radio waves through the probe. The radio waves generate heat, which both destroys adjacent tissue and cauterizes blood vessels. This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer pain that is not well controlled by other means, such as drugs. The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors. Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1 day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication. For the treatment, most patients will receive local anesthetic in the area where the probe is inserted. Some patients may require general anesthesia. The probe will remain in place typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.
The overall objective of this multi-center registry is to identify specific phenotypes of INOCA with both an anatomic evaluation (coronary angiography and intravascular imaging) and physiologic assessment with the Abbott Coroventis Coroflow Cardiovascular System, and to determine long-term outcomes.
Back pain is one of the most common complaints in pregnancy. It is caused by the growing pregnant abdomen which then strains the lower back and pelvis. Often Obstetricians recommend rest, Tylenol, pelvic support belts, or exercise. Typically, these do not provide the patient much relief. A physical therapy treatment known as soft tissue mobilization (tSTM) has been shown to be helpful in treating various types of pain. This study will explore whether tSTM can improve back pain in pregnancy.
The investigator hypothesizes that a benign directed ultrasound, when performed after a normal digital mammogram, will provide women with focal breast pain additional reassurance that the etiology of their symptom is benign. 160 women over the age of thirty with focal breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 - 7/1/2018 will be selected and randomized to three groups using a block randomization technique. All study participants will complete a survey assessing psychosocial factors, then receive a digital mammogram. Patients with a negative mammogram will continue on with the study and will either have a conversation about their negative mammogram with a radiologist or receive a directed ultrasound. A second survey will be conducted assessing psychosocial factors. All study participants who did not receive an ultrasound will receive an ultrasound so that all study participants are provided with the standard of care for focal breast pain. The results of the survey will be compared and appropriate statistical analyses such as an Analysis of Variance (ANOVA) test will be conducted to determine any statistically significant differences between the three randomized groups. The risks/safety issues of this study are believed to be minimal.
The purpose of this study is to compare the amount of acetylcholine release after a single injection of clonidine in normal volunteers and individuals with neuropathic pain.
Rotator cuff disease (i.e., rotator cuff tendinopathy or tear) is a common cause of shoulder pain in persons with chronic spinal cord injury (SCI). It usually resolves with non-operative treatments such as pharmacological agents and physical therapy; however, when this fails, rotator cuff surgery may be the only option. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes). The purpose of this study is to explore the safety and efficacy of autologous, micro-fragmented adipose tissue (Lipogems®) injection under ultrasound guidance for chronic shoulder pain in persons with SCI.
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. Post-operative pain scores will be measured by a 0-10 Likert scale 6 hours after the end of surgery while the patient is still hospitalized (post-operative day 0). This will be patient-provided data. Unblinded data analysis will compare scores between treatment and control groups. Secondary Objectives To determine if post-operative moving pain scores, opioids use, nausea, and sleep interference differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. Pain score, opioids use, nausea, and sleep interference data will be collected via patient self-report. When possible (i.e., while hospitalized) objective data on opioids and other pain medication administered to the patient will be used. Tertiary Objectives To determine if long-term changes in Quality of Life scores \[the RAND-36 Health Survey, Disability of the Arm, Shoulder, and Hand (Quick DASH) questionnaire, and Breast-Q scores\] differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. This data will be collected via validated questionnaires through patient interviews at 3-months, 2-years, and 4-years (±14 days) after surgery. Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years following surgery in order to get final pain scores and quality-of-life/health outcome survey information. Participants who cannot be contacted after several phone attempts and the sending of 2 certified letters via US Postal Service for 3-month, 2-year, and/or 4-year outcome assessments will be considered lost to follow-up.
About 15 to 20 percent of individuals living in the United States have chronic abdominal pain, often of unknown origin, which is often difficult to diagnose and treat. One possible cause of chronic abdominal pain is an inflammation of the intestines, but it is not known whether the two are related. Furthermore, although overweight people tend to be more likely to have increased inflammation, it is not known whether there is a connection between increased body weight and chronic abdominal pain. This study will examine the relationship between symptoms of chronic abdominal pain and intestinal inflammation by comparing the medical test results of normal weight and overweight patients who have a history of chronic abdominal pain. This study will include 224 subjects, who must be men and women between the ages of 13 and 45. Half the subjects will be healthy participants, and half will have had chronic abdominal pain of unknown origin for longer than 6 months. Female participants must take a urine pregnancy test before starting the study, and will not be allowed to participate if the test is positive. During the study, patients will visit the NIH Clinical Center on two occasions for testing. On the first visit, patients will provide a medical history, including information about current medications or natural remedies and tobacco and alcohol use, and will also fill out questionnaires to provide information about symptoms, current levels of gastrointestinal pain, and general quality of life. The study researchers will conduct a physical examination, measure patients height and weight, and draw blood for testing. Patients will be asked to not eat or drink anything for 8 hours before the second visit, and will be asked to bring a bathing suit and a swim cap to the Clinical Center. On the day of the visit, patients will fill out questionnaires to provide information about symptoms, current levels of gastrointestinal pain, and general quality of life. Patients will also provide a blood sample for testing. Researchers will measure patients blood pressure and heart rate, height, weight, waist/hip circumference, and intra-abdominal measurement. Patients will also be asked to put on the bathing suit and swim cap to have their body fat measured using a machine called the BOD POD. To test the gastrointestinal system, patients will then be asked to drink a sugar-based test solution, and researchers will collect all voided urine for the next 5 to 6 hours. (Patients may drink water during this time.) On either Day 1 or Day 2 of the study, patients will sip, swish and spit an additional sweet taste solution. Patients will sip, swish, and spit different concentrations of this sweet taste solution, for a total of 25 tastings of this solution. Subjects will then complete questionnaires about their sweetness preferences related to these 25 tastings.
The goal of this randomized cross-over mechanistic trial is to compare pre- and post-level cortisol and oxytocin changes in patients with chronic spine pain who receive either a hand's on (massage) or a hand's off (talk-based) approach. The study plans to address two primary aims. Specific Aim One: Directly compare pre- and post-session oxytocin and cortisol levels across two sessions of massage and talk-based therapy. Hypothesis 1: It is expected that in both treatments, oxytocin will increase and cortisol will decrease, demonstrating no significant between-group differences in hormone levels. Specific Aim Two: The study plans to compare pre- and post-session oxytocin and cortisol change scores a therapeutic alliance (TA) scale change scores and PROMIS patient-reported outcomes associated with pain, depression, and disability. Hypothesis 2a: It is projected that there will be moderate +/- relationships (R\>.4) between the therapeutic alliance change score and oxytocin and cortisol levels, suggesting that the hormones moderately reflect the construct associated with TA. Hypothesis 2b: It is expected that there will be weak (R\>.1) +/-relationships between hormone measures and PROMIS pain/disability/depression measures, which reflects similar findings to preliminary work. Participants will participant in a massage based treatment and a talk-based treatment approach. Participants will also complete patient report outcomes and will receive a total of four salivary swabs.
This document is a protocol for a human research study. This study is to be conducted according to United States standards of Good Clinical Practice in accordance with applicable Federal regulations and institutional research policies and procedures. Extracellular matrix grafts have been used to help with postoperative inflammation.
The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will reduce pain scores related to that procedure. In a double blinded randomized trial of 60 women receiving either normal saline or lidocaine infused through an endometrial aspirator, pain scores will be obtained for each step of the IUD placement procedure and for the total experience.
To understand the effects of leg strengthening exercise, we will study the effects of strength training of the legs in four groups of people: (1) osteoarthritis (OA) with knee pain; (2) OA without knee pain; (3) no OA but elderly with knee pain; and (4) normal elderly with no OA or knee pain. In each of the first three groups, we will look at whether people who do strength training have less pain and/or slower progression of x-ray signs of OA over 30 months than people who perform nonstrengthening, range-of-motion exercises. We are including the fourth group to find out whether people with OA (groups 1 \& 2) have the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 \& 3) have the same response to training as those without joint pain.
The purpose of this study is to evaluate the safety profile of BRC-OA for pain treatment in patients with mild to severe OA of the knee, focusing particularly on two distinct doses. Alongside safety assessments, the study also aims to investigate the initial efficacy of BRC-OA in treating pain among these patients. The study product is a cryopreserved devitalized adipose tissue allograft (BRC-OA). BRC-OA is composed of a devitalized human adipose particulate that retains the inherent properties of adipose such as tissue architecture, extracellular matrix, and signaling molecules.
The purpose of this research study is to determine if the effectiveness of a single injection of CTM Boost in the treatment of patients with rotator cuff tendinopathy (RCT) is as effective as a single injection of platelet rich plasma (PRP) in reducing the symptoms of RCT.
This research project is intended to understand the mechanisms of action for the pain-relieving properties of visual green light exposure. The investigators have shown previously that greenlight exposure decreased acute and chronic pain in both animals and humans. However, the investigators do not yet understand how green light exposure is capable of such function.
When harvesting autogenous free grafts to treat periodontal conditions (e.g., lack of attached keratinized tissue, ridge defects, and other mucogingival deformities), the hard palate is the preferred donor site. The primary disadvantage of this technique is the creation of a second surgical site. This sacrificial traumatic lesion on the palate is associated with significant post-operative morbidities, including patient discomfort, infection, inflammation, hemorrhage, and necrosis. A pilot, blinded Randomized Control Trial will be conducted with subjects who are treatment planned to receive free gingival graft palatal harvest surgery. The palatal wound donor site for treatment group 1 will not receive an allograft membrane; while the donor site for treatment group 2 will receive an amnion-chorion allograft membrane (BioXclude) secured with a suture. The severity of pain at the palatal wound site will be assessed using an at home survey (Visual Analog Scale, Pain Catastrophizing Scale, \& Patient-Reported Outcomes Measurement Information System Scale). The healing of the palatal donor site will be evaluated quantitatively and qualitatively (PVS impression, optical scan, endoscopy, and ultrasnonography).
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.
This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.
The purpose of the study is to investigate in healthy human subjects how much desmetramadol (Omnitram) gets in the blood after different oral doses are taken with or without food.
The purpose of this study is to assess safety and efficacy of BAY 1817080 compared to elagolix and placebo in women with symptomatic endometriosis. Study details include: * Study duration: 155 up to 285 days * Treatment duration: 84 days * Visit frequency: 3 laboratory every 2 weeks for participants on BAY 1817080 or placebo
The purpose of this study is to determine if creation of a skin wheel with bacteriostatic normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar level of anesthesia compared to 1% lidocaine. Participants will receive both types of anesthesia, in random order.