Treatment Trials

26 Clinical Trials for Various Conditions

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SPR PNS for Chronic Shoulder Pain
Description

The purpose of this research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. The System delivers mild electrical stimulation to the muscles in your shoulder. The System includes up to two leads (small wires) that are placed through your skin into your shoulder. The leads attach to a device worn on your body that deliver stimulation (called a Stimulator). The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain.

Conditions

Shoulder Pain, Shoulder Injuries, Shoulder Arthritis

Embodiment in Virtual Reality as a Telemedicine Digital Therapeutic for the Treatment of Chronic Shoulder Pain
Description

Chronic shoulder pain is a common musculoskeletal pain condition that can have a profound impact on a sufferer's life and a large socioeconomic healthcare burden to society. The aim of this study was to determine the feasibility of delivering telemedicine enabled functional shoulder rehabilitation for chronic shoulder pain patients using immersive virtual reality. Ten chronic shoulder pain patients were recruited from local pain clinics. Patients engaged in three sessions of virtual embodiment training per week over the course of eight weeks. Rehabilitation sessions were delivered on an Oculus Quest head-mounted display and hand controllers. Rehabilitation exercises (virtual embodiment training) leverage techniques from graded motor imagery, such as visual mirror feedback and augmentation of the virtual avatar's movements. Eight pain assessments were administered prior to the first session, and at weeks four and eight to get an indication of the effect that telemedicine delivered virtual embodiment training has on symptoms of chronic shoulder pain.

Conditions

Chronic Pain, Low Back Pain, Shoulder Pain

Micro-Fragmented Adipose Tissue (Lipogems®) Injection for Chronic Shoulder Pain in Persons With Spinal Cord Injury
Description

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.

Conditions

Shoulder Pain, Shoulder Impingement Syndrome, Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Syndrome of Shoulder and Allied Disorders, Spinal Cord Injuries

"MILNACIPRAN" in Subjects With Chronic Shoulder Pain
Description

The purpose of this study is to compare the safety and efficacy of multiple doses of "Milnacipran" to a placebo dose in subjects with Chronic Shoulder Pain.

Conditions

Chronic Shoulder Pain

Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)
Description

The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.

Conditions

Osteoarthritis

An Implantable Microneuromodulator for the Treatment of Chronic Shoulder Pain in Chronic Post-Stroke Subjects
Description

The goal of this research study is to investigate safety and gather initial effectiveness data for a new implanted device designed to treat chronic shoulder pain in chronic post-stroke subjects. The BBPM weighs less than 0.03 ounces and measures 1" x 0.1". It is implanted into the shoulder to stimulate the axillary nerve. Stimulation of this nerve may reduce shoulder pain, reduce shoulder subluxation, improve motion, improve function, and possibly decrease use of pain medication. CAUTION--Investigational device. Limited by Federal law to investigational use.

Conditions

Shoulder Pain Chronic

Treatment of Shoulder Osteoarthritis
Description

The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity ("electrical stimulation") to the nerves relaying sensory information to the shoulder. This study will use a device called Sprint PNS system. PNS stands for Peripheral Nerve Stimulation. This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

Conditions

Chronic Shoulder Pain

Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Description

The purpose of this study is to evaluate the effectiveness and safety of using suprascapular nerve block for individuals with chronic spinal cord injury who have chronic shoulder pain.

Conditions

Chronic Shoulder Pain

Arthroscopic Transosseous vs. Anchored Rotator Cuff Repair
Description

This study will compare arthroscopic transosseous versus anchored rotator cuff repairs in terms of clinical outcomes, rotator cuff integrity, and cost-effectiveness. With the collection of patient-reported outcomes the health of patients undergoing each rotator cuff repair technique will be assessed. The aims of this study will be achieved through a clinical randomized controlled trial and a cost-effectiveness analysis.

Conditions

Shoulder Pain Chronic, Shoulder Pain, Rotator Cuff Tear, Rotator Cuff Injury

The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
Description

This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep quality in patients who present to UTSW physicians with shoulder pain. The investigators plan to randomize participants into treatment and control groups, but the investigators will provide education on sleep hygiene for each group. The treatment group will also receive instruction to mobilize their thoracic spine and ribs each night before going to sleep.

Conditions

Shoulder Pain Chronic

Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA
Description

This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and/or chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.

Conditions

Chronic Pain, Acute Pain, Post Operative Pain, Fibromyalgia, Primary, Fibromyalgia, Secondary, Fibromyalgia, Irritable Bowel Syndrome, Chronic Headache Disorder, Chronic Migraine, Chronic Pelvic Pain Syndrome, Temporomandibular Joint Disorders, Endometriosis-related Pain, Arthritis, Chronic Low-back Pain, Failed Back Surgery Syndrome, Post Herpetic Neuralgia, Neuropathic Pain, Painful Diabetic Neuropathy, Painful Bladder Syndrome, Trauma-related Wound, Trauma, Multiple, Chronic Pain Syndrome, Chronic Shoulder Pain

Digital Versus Conventional Physical Therapy for Chronic Shoulder Tendinopathy
Description

This is a single-center, prospective, randomised, controlled study, with two parallel groups, designed to assess the clinical impact of a digital exercise program against conventional rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured will significantly improve after the program, and patients using this novel system will attain at least the same outcomes than the ones attained by the conventional PT group.

Conditions

Musculoskeletal Pain, Chronic Shoulder Pain, Shoulder Tendinopathy

MDR SureLock All-Suture Anchor
Description

To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.

Conditions

Shoulder Pain, Shoulder Injuries, Shoulder Disease, Shoulder Pain Chronic, Shoulder Syndrome, Labral Tear, Glenoid

Chronic Pain, Couples, & Physical Activity
Description

Chronic pain affects more than 50 million adults in the United States and is estimated to cost the nation more than $560 billion dollars each year. Regular physical activity is widely recognized as essential for maintaining health for all individuals, but is particularly important for individuals with chronic pain (ICPs) as physical activity can prevent further deconditioning and may even improve pain outcomes. Previous literature has shown that certain categories of partner behaviors (e.g., solicitous, punishing, distracting) are associated with different health outcomes for ICPs, and recently researchers have begun examining partner behaviors through the lens of Self-Determination Theory, specifically looking at the effects of autonomy support from a spouse on physical activity among ICPs. Partner autonomy support has been positively associated with physical activity levels and better health outcomes, but no studies to date have explored what factors predict whether or not a partner will use an autonomy supportive interpersonal style (as opposed to a controlling interpersonal style) with the ICP. Similarly, more research is needed on the mechanisms by which autonomy support promotes positive outcomes for ICPs. Though receiving autonomy support has been linked to increased physical activity and improved mental health, no studies have yet tested the full Self-Determination Theory model as one possible explanation of the link between this form of partner support and desirable health outcomes. In particular, it is important to understand the ICP's perspective on how partner autonomy support influences need satisfaction and autonomous motivation as possible mediators between autonomy support and ICP physical activity. Furthermore, little research has explored other need supportive behaviors or their need frustrating counterparts. The current study will not only provide greater understanding of autonomy support, but will also expand the literature regarding these other need supportive and need thwarting behaviors. Lastly, given the value of need supportive behaviors from one's partner, it is essential to evaluate how partner perceptions of those need supportive behaviors align with ICP's perceptions of those behaviors. Any need support a partner provides is likely moderated by the ICP's perception of that support.

Conditions

Chronic Pain, Fibromyalgia, Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Ankylosing Spondylitis, Rheumatoid Arthritis, Chronic Low-back Pain, Chronic Shoulder Pain

Electrical Stimulation for the Treatment of Chronic Post-Stroke Shoulder Pain Using the Smartpatch System
Description

The purpose of this study is to determine if electrical stimulation (small levels of electricity) reduces post-stroke shoulder pain. This study involves a device called the Smartpatch System. The Smartpatch System delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a "Lead") that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator).

Conditions

Post-stroke Shoulder Pain, Hemiplegic Shoulder Pain

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy
Description

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

Conditions

Shoulder Pain, Tendinopathy, Rotator Cuff Tendinitis, Rotator Cuff Tendinosis, Embolization, Arterial Occlusion

Perfusion MRI-targeted Joint Embolization for Chronic Musculoskeletal Pain of the Shoulder, Hip and Knee
Description

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.

Conditions

Osteoarthritis, Knee, Osteoarthritis, Hip, Osteo Arthritis Shoulders, Synovitis of Knee, Synovitis/Tenosynovitis - Hip, Synovitis, Pain, Chronic

Trial for Shoulder Pathology and Pain in Chronic SCI
Description

This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.

Conditions

Shoulder Pain

StimRouter™ for Pain Management in Post-stroke Shoulder Pain
Description

StimRouter Neuromodulation System includes an implanted lead which provides peripheral nerve stimulation for chronic pain. Post-stroke shoulder pain patients will be the focus of this study. After meeting inclusion/exclusion criteria, approximately 50 enrolled patients will participate in the study through 6 months of follow-up. Various measures will be used to assess patient response to use of the device.

Conditions

Chronic Pain, Hemiplegic Shoulder Pain

Noxipoint Therapy Versus Standard Physical Therapy Using Electrical Stimulation for Chronic Pain
Description

The purpose of this study is to validate the efficacy of Noxipoint(TM) therapy on chronic pain, and compare it with standard physical therapy using electrical stimulation on patients with chronic pain. Invented by Dr. Charlie Koo at Stanford University, Noxipoint Therapy is a specific procedure with precise location, duration and intensity of TENS stimulation within the general FDA guidelines. The therapy substantially relieves general muscular/tendon pain and persistently restores the muscle and tendon function. The surface locations of nociceptors at the free nerve ending (i.e., "Noxipoints") are focused on in the stimulation therapy. Multiple clinical uses of Noxipoint Therapy confirmed the consistent efficacy of such stimulation at Noxipoints. An observational study of Noxipoint therapy within the FDA-approved use of TENS demonstrated an encouraging 93% success rate in eliminating the chronic pain, such as frozen shoulder pain, within 2-3 sessions. It is an order-of-magnitude improvement over the non-specific application of TENS and any other modalities in pain treatment. A unique neuro-immuno-signaling pathway that implicates the activation of adult stem cells, such as satellite cells in muscles, is implicated based on such a high success rate.

Conditions

Shoulder Pain, Neck Pain

Feasibility of Near-infrared Spectroscopy to Measure Cortical Pain Pathway (Brain) Activation During Dry Needling
Description

The benefit experienced by some patients when treated with dry needling,1 combined with the field-expedient nature of this intervention, make dry needling uniquely suited for the military healthcare environment. An improved understanding of the mechanism by which dry needling exerts its clinical benefits will allow clinicians to adopt more efficacious treatment strategies for Soldiers with chronic musculoskeletal pain. The proposed study will utilize functional near-infrared spectroscopy and structural health monitoring (SHM) to provide insight on the central and peripheral mechanisms of dry needling. Phase 1 will compare the cortical pain pathway response of thirty participants with non-traumatic shoulder pain receiving either true or sham dry needling. An additional 15 participants will be enrolled to receive true dry needling to determine if brain responses may be able to predict clinical improvement (responders versus non-responders) in phase 2. Since chronic pain after musculoskeletal injury is the leading cause of medical discharge from service and a primary source of disability in the U.S. military2,3, improved complementary and alternative treatment strategies have the potential to have a large impact on both military readiness and health care costs within the Armed Forces.

Conditions

Shoulder Pain, Chronic Pain, Musculoskeletal Injury

Study of Strengthening Exercises and Improving Movement for Painful Shoulders in Adults With Spinal Cord Injury
Description

The purpose of this study is to conduct research to see if we can help people who have a spinal cord injury and shoulder pain to decrease the pain in the shoulders. We are investigating the effectiveness of a home exercise program for the shoulders and changes in how tasks are performed compared to an educational program on shoulder pain. There are no new experimental procedures included in this study; instead it is a comparison of two types of treatment that have been provided for this problem before. The new part of this study is the collecting of information before and after treatment. We hypothesize that those who participate in this home exercise program will have decrease shoulder pain and increase activity.

Conditions

Shoulder Pain

Cryoanalgesia to Prevent Acute and Chronic Pain Following Surgery: A Randomized, Double-Masked, Sham-Controlled Study
Description

The ultimate objective of the proposed line of research is to determine if cryoanalgesia is an effective adjunctive treatment for pain in the period immediately following various painful surgical procedures; and, if this analgesic modality decreases the risk of persistent postoperative pain, or "chronic" pain. The objective of the proposed pilot study is to optimize the protocol and collect data to power subsequent, definitive clinical trials. Specific Aim 1: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia decreases the incidence and severity of post-surgical pain. Hypothesis 1a (primary): The severity of surgically-related pain will be significantly decreased on postoperative day 2 with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1b: The incidence of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 1c: The severity of chronic pain will be significantly decreased one year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Specific Aim 2: To determine if, compared with current and customary analgesia, the addition of cryoanalgesia improves postoperative functioning. Hypothesis 2a: Following primary unilateral knee and shoulder arthroplasty as well as rotator cuff repair, joint range of motion will be significantly increased within the year following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment. Hypothesis 2b: Following video-assisted thoracoscopic surgery, inspiratory spirometry will be improved within the month following surgery with the addition of cryoanalgesia as compared with patients receiving solely standard-of-care treatment.

Conditions

Mastectomy, Upper Limb Amputation Below Elbow, Upper Limb Amputation Above Elbow, Lower Limb Amputation Below Knee, Lower Limb Amputation Above Knee, Knee Arthropathy, Shoulder Arthroplasty, Rotator Cuff Repair, Video-Assisted Thoracoscopic Surgery (VATS), Skin Grafting

Percutaneous Needle Tenotomy (PNT) Versus Platelet Rich Plasma (PRP) With PNT in the Treatment of Chronic Tendinosis
Description

Tendinopathy is a clinical syndrome of chronic pain and tendon degeneration that impairs a person's ability to perform daily activities and recreation. Traditional conservative treatments include activity modification, exercises, ice/heat, and medications and corticosteroid injection. A newer treatment is percutaneous needle tenotomy (PNT), in which the affected area is repetitively needled to disrupt pathological tissue and induce bleeding. This turns a nonhealing chronic injury into an acute injury with enhanced healing capability. Another is Platelet Rich Plasma (PRP), whereby patients' own platelets are injected into the affected area, also activating growth factors. There has been promising research in these tendinopathy treatments but more research is needed. The investigators plan to expand on prior studies to identify a reproducible and efficacious treatment for chronic tendinopathy to reduce pain and improve function and quality of life. Our goal in this study is to assess the efficacy of ultrasound guided (USG) PNT versus PNT with peritendinous PRP as a treatment for chronic tendinopathy.

Conditions

Chronic Tendinopathy

Embo Registry; National Registry for Artery Embolization
Description

Embo Registry is a retrospective and prospective observational study to evaluate real world effectiveness and the use of Artery Embolization as a treatment for chronic pain with patients that have osteoarthritis and localized pain to provide symptomatic relief. This study is to determine the efficacy and validity of procedure and that following procedure patients had decreased pain and improved quality of life.

Conditions

Chronic Pain, Osteoarthritis, Knee, Osteoarthritis Thumb, Osteoarthritis Shoulder, Pain, Chronic, Tendonitis Elbow, Tendonitis Shoulder, Tendonitis;Achilles, Tenosynovitis

Comparison of Outcomes Between Biceps Tenotomy and Tenodesis in the Treatment of the Long Head of the Biceps Pathology
Description

The purpose of the study is to determine what the different outcomes are for biceps tenodesis and tenotomy in the treatment of the long head of the biceps pathology.

Conditions

Chronic Refractive Bicipital Pain