Funded Research Projects

Neuroma Cooled Radiofrequency Ablation for the Treatment of Refractory Phantom and Residual Limb Pain; a Pilot Study.

 Residual and phantom limb pain occur frequently and negatively impacts the function and well-being of amputees. For many patients with amputations, pain is the biggest barrier to prosthesis use. Amputee pain is distinct from other forms of pain due to sudden nerve severance and gross anatomic restructuring. While post-surgical amputee pain often resolves, phantom limb pain (in a distribution of the limb that is now amputated) and residual limb pain (in the distribution of the intact residual limb) often persist months to years after amputation. Unfortunately, there are few evidenced-based guidelines for the treatment of this problem. A small number of studies highlighting medicines, therapies, percutaneous interventions and surgeries have demonstrated limited efficacy. The purpose of this study is to determine if cooled radiofrequency ablation of residual limb neuromas for the treatment of refractory and residual limb pain is an effective and durable pain relief technique. In addition, this study will evaluate this procedure's ability to reduce pain medicine use, improve function, and decrease incidence of residual limb nerve surgeries for 6 months following cooled radiofrequency ablation.

This project is funded by the Foundation for PM&R.

Principal Investigator: Cole Cheney, MD

 

Overuse Injuries / Injury Prevention: Detection of precursors to Achilles tendon, patellar tendon, and plantar fascia injury in student-athletes with ultrasound imaging.

Tendinopathies (a type of overuse tendon injury) for the patellar and Achilles tendons are common injuries related to sports involving running and jumping but are also common in the general population. Similar findings are seen for plantar fasciopathy. These injuries can be costly, involve time-intensive treatments, and result in significant loss of playing time. Accordingly, prevention of injuries to student athletes in the NCAA has become a high priority. The primary objective of this research is to non-invasively identify precursors to tendon injuries in athletes before they become symptomatic.  The goal is to use ultrasound imaging to identify abnormal-appearing tendons/fascia without any symptoms (asymptomatic abnormalities).  Once these specific tendon/fascoa abnormalities are identified, and once these abnormalities are shown to be predictive of future injury (symptomatic tendon/fascia injury), interventions can be implemented to reduce the progression from harmless precursor to costly injury.

This project is a part of a larger clinical study funded by the PAC-12 Conference.

Principal Investigator: Daniel Cushman, MD

  

Ultrasound evaluation of the patellar tendon and Achilles tendon as a predictor of future injury in distance runners

Tendon injuries are one of the most common overuse injuries in sports, with two tendons, the patellar and Achilles tendons, causing a significant proportion of these injuries. Treatment for these injuries tend to require a significant amount of time for complete recovery. The primary objective of this line of research is to non-invasively identify precursors to tendon injuries in runners before they become symptomatic.  The goal is to use ultrasound imaging to identify abnormal-appearing tendons without any symptoms (asymptomatic abnormalities).  We then will track subjects to see if these abnormalities are more likely to cause pain over time.  If these abnormalities are more likely to progress to symptomatic tendon pain, we can use this method as a screening test for those at risk of future injury.

This project is funded by the American Medical Society for Sports Medicine.

Principal Investigator: Daniel Cushman, MD

  

The NICA Injury Surveillance System:  A Prospective, Controlled Injury Prevention Intervention for High School Mountain Bike Teams

Sports epidemiology is often viewed as a 4-step process.  The first step is to systematically characterize sports injuries in detail, including types of injuries and factors associated with the occurrence of injuries.  The second step is to determine mechanisms of injury and pre-disposing factors for injury, with a focus on those that are modifiable.  The third step is to devise and implement prospective, controlled, data-driven injury reduction strategies that target modifiable mechanisms and pre-disposing factors.  The fourth step is to evaluate efficacy by comparing injury rates after any intervention with injury rates prior to the intervention. The primary goal of the National Interscholastic Cycling Association (NICA) Injury Surveillance System (ISS) is to decrease injury rates among youth mountain bike racers using this 4-step process.

This project is funded by the University of Utah’s Department of Orthopaedics Pediatric Grant.

Principal Investigator:  Joshua Klatt MD. Co-Investigators:  Daniel Cushman MD, Masa Teramoto PhD, and Stuart Willick, MD

 

Reactive Postural Responses after Concussion: Objective Measurement of Balance Recovery and Prospective Injury Risk

Previously concussed, medically cleared athletes have double the odds of experiencing an acute musculoskeletal injury as their non-concussed teammates, but the cause of this increased injury risk is unknown. Wearable inertial sensors have identified residual impairments during challenging tasks, suggesting subtle balance deficits may persist beyond clinical recovery. However, despite the common need for athletes to reactively recover balance, reactive postural responses have received little attention after concussion. We hypothesize that the high rate of musculoskeletal injuries after concussion is in part due to impaired postural responses. This project will characterize acute and longitudinal deficits in reactive postural responses in athletes with a recent concussion compared to healthy control subjects.

This project is a part of a larger clinical study funded by the PAC-12 Conference.

Principal Investigator: Peter C. Fino, PhD. Co-Investigator:  Daniel Cushman, MD

 

International, Multicentre, Observational, Prospective, Longitudinal Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSH) 

Spasticity is one of the most common and disabling conditions associated with many neurological diseases in adults. Spasticity is characterized by the co-occurrence of paresis and involuntary velocity-dependent muscle hyperactivity due to exaggerated stretch reflexes, resulting in greater resistance to passive movement. The most effective pharmacological treatment of spasticity is botulinum toxin injections. Following recent approvals of Dysport for Adult LLS treatment in many markets, this international, multicentre, observational longitudinal study aims to assess the use and effectiveness of aboBoNT-A in real world clinical practice. This study also aims to assess in a real life setting the treatment management of adult subjects who receive aboBoNT-A for LLS, that may be associated with ULS.

This project is funded by Ipsen Pharma.

Principal Investigator: Steven Edgley, MD

 

Evaluation of the Long-Term Effects of Surgical Management of Spinal Cord Perfusion Strategies Using a Porcine Spinal Cord Injury Model

Currently the standard of surgical care of traumatic spinal cord injury (SCI) is based on alleviating compression to the injured spinal cord and artificially elevating the blood pressure in the hope that this aids spinal cord perfusion. The objective of this project is to directly test physiological assumptions that currently guide clinical management. In this highly translational research application, we will use a well-characterized and clinically relevant large animal model (porcine contusion SCI) to directly measure the spinal cord perfusion after SCI. Additionally, we will systematically evaluate the effect of the most common management strategies used as standards of care in the clinical management of spinal cord perfusion pressure on the local perfusion and long-term functional outcomes (motor and sensory) in the porcine model. 

This project is funded by the Department of Defense.

Principal Investigator: Candace Floyd, PhD

 

Pro-Inflammatory and Lipid Biomarkers after Spinal Cord Injury.

The goal of this study is to map the time course of inflammation markers and markers of lipid damage after spinal cord injury (SCI) in a pig model. The aims of the are to determine the time course of leukocyte activation and infiltration after porcine contusion SCI as well as to determine the time course of leukocyte activation and B1 integrin expression in human SCI. 

This project is funded by the National Institutes of Health CCTS University of Kentucky/University of Utah Inter-Institutional Pilot Collaborative Translational Science Award.

Principal Investigator: Candace Floyd, PhD

 

Focused Ultrasound Neuromodulation of Dorsal Root Ganglion for Noninvasive Mitigation of Low Back Pain.

The goal of this project is to test the efficacy of focused ultrasound to alleviate pain, using a pig model of low back pain. We aim to establish electrophysiologic normative data for detecting changes in pain in neuritis models and normals measured by EEG and somatosensory evoked potentials. The study will then demonstrate FUS neuromodulation of the DRG in pigs by (a) exploring FUS sonication parameters that results in DRG neuromodulation as assessed by SEPs during nerve stimulation and (b) evaluating the safety and efficacy of non-invasive FUS neuromodulation in neuritis pig model and controls by performing longitudinal unique behavioral assessments, which specifically test behaviors indicative of supraspinal pain sensation. Finally, we will design and construct an LBP-specific MRgFUS device for rapid translation to patients with back pain by fully characterizing FUS sonications for DRG neuromodulation using regulatory standards, constructing an MRI radiofrequency coil and transducer mount to allow targeting of the DRG in humans, and evaluating the prototype for image and sonication quality.

This project is funded by the National Institute of Neurological Disorders and Stroke.

Principal Investigator: Viola Rieke, PhD. Co-Investigator: Candace Floyd, PhD

 

Microglial Function and Neurological Outcome in Rat Pups after Experimental Traumatic Brain Injury: Effects of Timing and Duration of Docosahexaenoic Acid Therapy.

The goal of the project is to test the efficacy of DHA as a therapy for pediatric brain injury in a rat model. To accomplish this, we aim to test the hypothesis that DHA confers neuroprotection in a pediatric rat model of brain injury and to test the effect of DHA on inflammation and microglial activation in a pediatric rat model of brain injury

This project is funded by the National Institute of Neurological Disorders and Stroke.

Principal Investigator: Michelle Schober, MD. Co-Investigator: Candace Floyd, PhD

 

Patient-Centered Rehabilitation and Dexterous Assistive Devices for Stroke Patients Using Bionic Exoskeletons Controlled by Non-Invasive Electromyography

Stroke is one of the leading causes of disability worldwide and the most common stroke-related impairment is upper-limb hemiparesis, affecting 80% of stroke patients acutely and 40% chronically. Full recovery is unlikely with current rehabilitation approaches, and as a result, stroke reduces quality of life, increases healthcare costs, and burdens caregivers. The long-term goal of this project is to leverage assistive bionic devices to restore motor function and promote long-term neuro-regeneration, ultimately replacing more expensive and less effective rehabilitation approaches with a patient-centered rehabilitation strategy. The objective of this project is to control assistive bionic exoskeletons and quantify stroke recovery with electromyographic (EMG) recordings of residual muscle activity from the paretic arm. Our central hypothesis is that an EMG-controlled powered orthosis – that assists individuals in activities of daily living – can be used as a patient-specific rehabilitative tool that improves stroke recovery. Aim 1 will adapt dexterous EMG-control algorithms for upper-limb orthoses, and then demonstrate improved hand dexterity and functional mobility for stroke patients. Aim 2 will utilize large EMG datasets over time to precisely quantify changes in muscle strength and spasticity throughout recovery and to provide robust long-term control of assistive devices via deep learning. Aim 3 consists of a pilot study to determine the feasibility of patient-specific assistive-device-driven rehabilitation. The proposed research is innovative because it will address gaps in knowledge critical to merging assistive and rehabilitative devices. These findings are significant because they will enable devices that can immediately and simultaneously promote usage, strengthen muscles, and provide closed-loop visual feedback – thereby merging multiple effective rehabilitation strategies into a single holistic approach. This proposal will have a positive impact on society by increasing rehabilitation compliance, promoting independence and improving recovery outcomes for stroke patients, ultimately reducing healthcare costs and improving patients’ quality of life.

This project is funded by the National Institutes of Health: Office Of The Director, Eunice Kennedy Shriver National Institute Of Child Health & Human Development (NICHD), and National Institute Of Dental & Craniofacial Research (NIDCR).

Principal Investigator: Jacob A. George, PhD

 

Hyperhidrosis of the Residual Limb in Patients with Amputations: Developing a Treatment Approach

Despite the frequency and impact of hyperhidrosis in amputees, there is a lack of evidence-based guidelines for evaluating and treating this problem.  A number of knowledge gaps exist, including no clear standard for assessing the burden of sweating in amputees, and no evidence base from which to inform treatment decisions for either simple or more elaborate interventions. The objective of this study is to establish an evidence base for a hyperhidrosis treatment algorithm in amputees.  We will accomplish this by completing the following specific aims. Aim 1) Test the validity of the Minor iodine-starch test in amputees, a test that consists of an application of iodine, which is allowed to dry and then dusted with cornstarch. Aim 2) Test the effectiveness of a prescription strength topical antiperspirant (Aluminum Chloride 20%) on hyperhidrosis of the residual limb. Aim 3) Test the effectiveness of Botulinum Toxin Therapy in subjects who fail Aluminum Chloride.

This project is funded by the Department of Defense.

Principal Investigator: Colby Hansen, MD. Co-Investigator: Bradeigh Godfrey, DO

 

Product Surveillance Registry (PSR)

The Product Surveillance Registry (PSR) is a web-based outcome registry designed to monitor the product performance of Medtronic Infusion Systems. The Registry is comprised of a global network of hospitals, clinics and clinicians from which reliable “real-world” product safety and patient clinical outcome information is generated. The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of market-released products for their intended use. Conducting product surveillance in large populations over time provides an effective means of assessing product performance, patient safety and clinical outcomes. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.

This project is funded by Medtronic.

Principal Investigator: Alison Oki, MD

 

A Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the treatment of Lumbosacral Radicular Pain due to Spinal Stenosis: The SAFE Trial.

There is a large population of patients with lumbosacral radicular pain due to spinal stenosis who do not respond to physical therapy or oral medication management, yet wish to avoid spinal surgery or are simply not candidates due to medical co-morbidity. Currently, the typical treatment for this population is serial corticosteroid injection. Sterile amniotic fluid filtrate is a promising new biologic treatment with neuro-protective and regenerative properties. The purpose of this study is to determine if epidural injection of sterile amniotic fluid filtrate compared to dexamethasone for the treatment of lumbosacral radicular pain due to spinal stenosis results in superior pain relief, superior reduction of functional disability, superior improvement in psychological functioning, superior reduction of oral analgesic use, including opioids, lower incidence of spinal surgery for refractory pain/stenosis symptoms, superior patient-perceived global impression of change, need for fewer repeat injections prior within 3 months from the index injection, and superior safety profile.

This project is funded by the Skaggs Research Foundation.

Principal Investigator: Zachary McCormick, MD

 

The Intracept Global Registry (TIGR)

Vertebrogenic pain from degenerated or damaged vertebral endplates is an important source of chronic low back pain (CLBP). The basivertebral nerve (BVN) within the vertebral disc has nociceptors that receive pain signals from the damaged and inflamed endplate(s) and transmit these pain signals to the central nervous system. The Intracept device is a minimally-invasive intervention using a transpedicular approach to deliver radiofrequency energy to ablate the BVN.  Once ablated, these nerves no longer transmit pain signals.  The objective of this independent data collection is to evaluate the “real world” effectiveness of the Intracept® Intraosseous Nerve Ablation System for the treatment of CLBP. This is a prospective, noninterventional, observational global post market data collection study of the effectiveness, safety, and satisfaction outcomes of patients treated with the Intracept Procedure.

This project is funded by Relievant Medsystems Inc. 

Principal Investigator: Zachary McCormick, MD

 

A Prospective, Multi-center, Randomized, Single-Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency ablation of the Genicular Nerves in the Management of Knee Pain in an Osteoarthritic Patient Population.

Radiofrequency ablation has emerged as a viable pain management option for patients suffering from pain related to OA of the knee. While the technology shows effect, there are limitations to its use and outcomes based on the variability of anatomy and physics involved with lesion creation. COOLIEF* Cooled Radiofrequency Ablation (CRFA) was developed to overcome those limitations. This prospective, multi-center, randomized, single-blind comparison study examines the effects of the COOLIEF* Cooled Radiofrequency Probe used for radiofrequency neurotomy of the genicular nerves compared to Standard Radiofrequency Probe in patients to manage osteoarthritic knee pain. The primary rationale for conducting this study is to formally compare the two technologies to determine if there are differences in both effect and durability of analgesia associated with the use of one technology compared to the other.

This project is funded by Avanos Medical Inc. 

Principal Investigator: Zachary McCormick, MD

 

A Prospective Trial of Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome

 Chronic, non-neurogenic low back pain (CLBP) is a common condition that affects many individuals across their lives. The lumbar facet joint has been implicated as an important source of this pain. This study seeks to measure outcomes by examining two currently used and recognized standard of care procedures, Cooled Radiofrequency Ablation (C-RFA) of the medial branch nerves (MBN) and zygapophyseal (“facet”) joint injection of corticosteroid (FJI).

The objectives of this project are to 1) determine the proportion of patients with a successful response to lumbar MBN C-RFA versus facet joint injection of corticosteroid 2) evaluate the functional improvement observed in both groups 3) evaluate reductions in opioid and non-opioid analgesic use in both groups 4) evaluate differences in the proportion of patients with a successful treatment response in those who report 100% relief from dual comparative diagnostic lumbar MBN blocks relative to those with at least 80% improvement but less than 100% relief from the dual comparative blocks and 6) Report immediate, short-term, and long-term adverse effects, using a standardized survey that includes a comprehensive query of known adverse events associated with systemic steroid effects.

This project is funded by Avanos Medical Inc.

Principal Investigator: Zachary McCormick, MD 

  

A Randomized, Controlled, Multicenter Trial of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Back Pain

Chronic low back pain (CLBP) is a significant problem. For many patients, current are often ineffective or associated with side effects and complications. Percutaneous peripheral nerve stimulation (PNS) has been shown to relieve CLBP, while improving disability and quality of life. This study aims to determine if the safety and effectiveness of percutaneous PNS is equivalent (and if so, if it is superior) to that of standard of care management of CLBP and to determine if PNS produces clinically significant reductions in pain, disability, and other key patient-centric outcomes. A health economic analysis will be performed as part of this multicenter randomized controlled trial.

This project is funded by SPR Therapeutics.

Principal Investigator: Zachary McCormick, MD

 

A Sequenced-strategy for improving outcomes in people with Knee OsteoArthritis Pain (SKOAP)

There is an urgent public health need to reduce our reliance on opioids for effective long-term pain management, particularly in the case of knee osteoarthritis (KOA). This effectiveness trial compares standard of care recommended treatments to reduce pain and functional limitations due to KOA and seeks to identify clinical and patient factors associated with a successful treatment response. These results will lead to improved patient selection for treatment and inform evidence‑based guidelines by offering well-tested, effective, non-opioid alternatives. To accomplish this, the study’s main objectives are 1) to determine the extent to which duloxetine and the combined effects of PainTRAINER (phone app) and duloxetine improve pain and function in participants with KOA; 2) among those interested in additional treatment, including those following conservative treatment and those inappropriate for conservative care, determine whether nonsurgical procedural interventions improve pain and function; and 3) to identify clinical and psychosocial phenotypes that predict short- and long-term outcomes.

This project is funded by National Institutes of Health, John Hopkins sub-award.

Principal Investigator: Zachary McCormick, MD

 

The Effectiveness of Cervical Transforaminal Epidural Steroid Injection for the Treatment of Cervical Radicular Pain: A Prospective Cohort Study.

Neck pain is now the fourth leading cause of years lost to disability, shortly after back pain, depression, and arthralgia. A significant proportion of patients experience severe pain and associated functional impairment despite conservative care, which often prompts physician directed interventions. Cervical transforaminal epidural steroid injection (TFESI) is a target-specific treatment for refractory radicular pain. Few studies have addressed clinical outcomes associated with cervical TFESI in which appropriate procedure technique, outcome measurement, data analysis, and results interpretation have been reported. This study is intended to assess outcomes for 1 year following cervical TFESI. The aim is to determine the proportion of patients with improvement in arm and neck pain, physical function, sleep, and analgesic medication use following an initial cervical transforaminal steroid injection (TFESI) at 4 weeks post-injection and the duration of response up to 12 months. 

This project is funded by the Spine intervention Society.

Principal Investigators: Aaron Conger, DO and Zachary McCormick, MD  

 

Project RACR: Promoting Resilience, Adjustment, and Community Reintegration after Spinal Cord Injury (SCI)

Many individuals with SCI identify a need for interventions to address SCI-related social impacts at the community and family level such as employment, assistance with mobility and transportation, and restoration of meaningful relationships and social roles. The objective of this study is to address the current need for individualized interventions that promote adjustment and resilience through increased community participation (CP) after spinal cord injury (SCI). This will include engaging an expert panel of individuals with SCI, caregivers, and SCI rehabilitation specialists to identify relevant existing modules and develop new interventions, delivering the intervention to a sample of at least 20 community dwelling individuals with SCI, and finalizing the adapted intervention after incorporation of feasibility feedback for future use in an efficacy trial that includes randomization and assessment of behavioral change and clinical outcomes. 

This project is funded by the Craig H. Neilsen Foundation.

Principal Investigator: Melody Mickens, PhD

 

Head Trauma: The Subtypes of Concussion – Classification and Recovery Trajectories in Pac-12 Student Athletes

The goal for this study is to advance the science of concussion care and change how concussions are diagnosed and managed, allowing for earlier and more focused rehabilitation and treatments. By performing clinical research, this study will look to characterize and compare concussion subtypes over time and by gender, sport, school and medical history, including cardiovascular health, while also assessing recovery trajectories by concussion subtypes over a six-month span to allow for anticipated outcomes and targeted-treatment options.

This project is funded by the PAC-12 Conference. 

Principal Investigator: Angela Lumba-Brown, MD (Stanford). Co-Investigator: Masaru Teramoto, PhD.

 

Research Volunteers

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Research Volunteers

CONTACT US

 

PM&R Research Office
Heidi Hansen, Research Coordinator
University of Utah, Craig H. Neilsen Rehabilitation Hospital
85 North Medical Drive
Salt Lake City, UT 84132

Telephone: 801.585.2373
Email: heidi.hansen@hsc.utah.edu
Fax Number: 801.646.8980