Pain Faculty Grants and Awards, 2023
Project Title: Spinal Cord Stimulation improves pain, arterial stiffness and vascular flow in lower extremities in patients with Diabetes Mellitus Type II: A Multidisciplinary Collaborative Prospective Study
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Diabetes Mellitus (DM) is one of the most prevalent pathologies located across the globe, with a series of sequelae including, but not limited to, painful peripheral neuropathy and microvascular changes which can result in long-term health outcomes such as diabetic foot syndrome. As such, one of the FDA approved diagnoses for SCS implantation is painful peripheral neuropathy, which helps alleviate pain associated with small fiber neuropathy. Furthermore, it is postulated that SCS and neuromodulation of the autonomic nervous system can have a positive effect on vascular compliance in peripheral arteries, thus favorably influencing blood flow variations in those with DM who suffer from microvascular impairment. What the researchers aim to achieve with this multidisciplinary, collaborative, prospective study is to evaluate not only the effect of SCS on painful peripheral neuropathy in those with DM but also to measure the effects that SCS systems have on the microvascular environments and further understand the local reversible physiologic and metabolic changes associated with arterial stiffness in DM. The study is sponsored by the Women Board of the University of Chicago and was awarded by this entity through competition with other similar projects across Chicagoland region.
Project title: Genicular artery embolization improves pain and function in patients with moderate osteoarthritis refractory to conservative regimen
Co-investigator: Magdalena Anitescu MD, PhD
Overview: Knee osteoarthritis is one of the most common conditions encountered in physicians’ offices. While many treatments have been explored, to date, the ultimate treatment of knee OA is through knee replacement surgery. However, many patients have significant co-morbidities that preclude a surgical intervention; as such, genicular artery embolization is emerging as a possibility of treatment in situations when surgery is not indicated. Through a collaboration with interventional radiology section, the researchers aim to show effectiveness of this therapy for patients previously treated unsuccessfully with pain interventions. The study is supported through a grant awarded by Cannon to the principal investigator, Dr. Osmanuddin Ahmed in Interventional Radiology with Dr. Anitescu as principal co-PI.
Project Title: Educational activities to allow adoption of fascia iliaca block in Emergency department with involvement of pain service
Co-investigator: Magdalena Anitescu MD, PhD
Overview: As fracture of femoral head is a very painful condition requiring significant amounts of opioids, the patients suffering from this condition also are brought to hospital primarily to the emergency department often in the middle of the night; oftentimes, while they would benefit from regional analgesia there are not health providers that are comfortable with performing those procedures. Through a collaboration with ED physicians, the pain section initiated a project in which ED physicians would become comfortable with performing fascia iliaca block on patients with femoral head neck. The study is supported through a grant from The Mayday Fund to the principal investigator Dr. Tess Hogan with Dr. Anitescu as co-PI.
Industry sponsored studies
Project Title: FAST Study: A Study to Demonstrate the Value of Paresthesia-Free Fast-Acting Subperception (FAST) and other SCS therapies using WaveWriter™ Spinal Cord Stimulator Systems in the Treatment of Chronic Pain
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Parathesia-Free Fast-Acting Subperception (FAST) has emerged as one of the leading SCS therapy alternatives for the treatment of chronic intractable pain (CIP). The system works via the principle of surround inhibition – a mechanism by which the area of pain overlap is identified, and the corresponding inhibitory neurons are activated at specific subperception settings to effectively and expeditiously provide pain relief. This system not only provides parathesia-free pain relief, but also does so in a fraction of the time when compared to other forms of SCS which can take hours and/or days to obtain an effect. This project consists of a prospective, multi-center, single-arm study aimed at both evaluating the efficacy of the FAST-SCS system and additional SCS therapy options but also analyzing more objective metrics such as quality of life and patient preference, to name a few, from the patients receiving treatment. This study sets to answer the question as to whether the FAST-SCS can produce timely and efficacious relief of back pain as well as to shed light on the evolving technology associated with the treatment of CIP moving forward.
Project Title: SOLIS Study: A Randomized Controlled Study to Evaluate the Safety and Effectiveness of Boston Scientific Spinal Cord Stimulation (SCS) Systems in the Treatment of Chronic Low Back and/or Leg Pain with No Prior Surgeries
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: SCS therapy has long been used as an alternative treatment modality when conventional medical management (CMM) falls short of adequately controlling chronic intractable pain. The progression of CMM most often begins with oral medication, followed by physical therapy and/or less invasive interventions (kyphoplasty, neuraxial injections), with finally resorting to spine surgery if one’s pain persists. If surgery does not significantly relieve the pain, it is at this time that one typically becomes a candidate for SCS however what SCS as an Option for chronic Low back and/or leg pain Instead of Surgery (also known as SOLIS) aims to evaluate is the effectiveness and safety of WaveWriter SCS therapies before resorting to more invasive surgical options as dictated by CMM. This study consists of a prospective, multi-center, parlay-group randomized control trial with the intent of evaluating Boston Scientific Wave-Writer SCS systems provided to individuals with and without prior surgery. This project sets to answer the question as to whether patient outcomes related to safety and efficacy significantly differ depending on one’s surgical history prior to SCS implantation, as well as to help identify where SCS may fit into the CMM equation moving forward.
Project Title: A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated with Advanced Cancer
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Cancer related intractable pain, especially in advanced cancer where one’s malignancy is unlikely to be cured or controlled with treatment, is a widely seen sequela of metastatic spread that has historically been controlled with opioids in spite of less effective alternative forms of analgesia. Upon further molecular investigation, it has been seen that the transient receptor potential vanilloid-1 (TRPV1) receptor is selectively upregulated in the CNS in response to chronic noxious pain. A molecule has been synthesized (known as Resiniferatoxin or RTX) that serves as an agonist of this receptor, thereby initiating apoptosis of the pain neurons expressing the receptor. With the help of Sorrento Therapeutics, Inc., the researchers of this multicenter, phase 2 study aims to evaluate the safety and efficacy of a one-time injection of RTX into the epidural space vs a control vehicle as it relates to treating cancer-related intractable pain, specifically at the midthoracic level (T4). This study will ultimately help answer if RTX can serve as a suitable alternative for treatment of intractable pain in advanced cancer as well as if epidural injection of RTX will help limit unwanted effects (as opposed to intrathecal injectate, allowing for distant spread and off-target effects).
Project Title: Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator (REALITY)
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Abbott Laboratories is a world leader in the medical device industry, and one of the pioneers for the modern-day Spinal cord stimulator (SCS). As such, the company has devised several different modalities for SCS systems, include tonic stimulation which delivers an impulse at a constant amplitude, frequency, and pulse width to provide paresthesia pain relief as well as BurstDRTM which delivers impulses in rapid succession followed by a silent phase. Furthermore, the systems can target not only the spinal cord for stimulation, but also dorsal root ganglia, depending on the electrode location. What this prospective, multicenter, open label trial aims to achieve is post market surveillance of their SCS systems relating to the efficacy of pain relief with the hopes of understanding the use of Abbott neuromodulation systems in a broader, real-world, and long-term setting.
Project Title: An interventional, Phase III, double-blind, randomized, controlled, parallel-group, multi-site, clinical trial evaluating the efficacy and safety of Qutenza® in subjects with post-surgical neuropathic pain
Principal Investigator: Dalia Elmofty, MD
Overview: Capsaicin is an organic nitrogenous molecule found commonly in hot peppers that has incidentally been seen to be effective at relieving the effects of neuropathic pain due to its agonism at transient receptor potential vanilloid-1 receptors (TRPV-1). TRPV-1 receptors are found in excess long small diameter sensory neurons, and thus the agnostic relationship is responsible for the reduction of pain produced from noxious stimuli acting on these neurons. Although used for several years to eliminate neuropathic pain, what this study aims to evaluate is the safety and efficacy related to a novel, high potency capsaicin drug known as Qutenza pertaining to relieving post-surgical neuropathic pain (PSNP) when compared to lower dosed capsaicin systems. This multi-site study will help shed light on whether or not this treatment modality is a suitable non-invasive alternative for the relief of PSNP as well as help further the scope of conventional medical management of chronic pain.
Project Title: A randomized, double-blinded, placebo-controlled, Phase III trial to evaluate the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in adult subjects with pain associated with osteoarthritis of the knee
Principal Investigator: Dalia Elmofty, MD
Overview: Knee osteoarthritis is one of the most common over-use related injuries leading to frequent pain with ambulation and disability. The standard of care for knee OA is similar to other forms of conventional medical management, including non-invasive strengthening exercises and medication all the way to more invasive forms such as surgery. One such form a treatment involves an intra-articular injection, dissimilar to other more common forms of injection including steroid and local anesthetic, containing RTX-GRT7039 which acts as an agonist of Transient Receptor Potential Vanilloid receptor 1 (TRPV1). This multi-site study will evaluate the safety and efficacy of a single injection of this chemical in comparison to a placebo. This study will serve as a means of analyzing this injection as a suitable form of injectate and will help mold the standard of care of knee osteoarthritis moving forward.
Internally Funded studies
Project Title: A retrospective chart-review of 27 patients with chronic back or radicular leg pain; analyzing the onset of analgesia in the novel Fast Acting Sub-perception Therapy (FAST) spinal cord stimulation (SCS) compared to conventional SCS therapy.
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Conventional SCS systems have been proven to effectively provide significant pain relief by way of decreased neuropathic pain via the process of habituation. These systems historically utilize the production of paresthesia to elicit the target effect, however, can take several days to achieve maximum relief. Novel SCS systems have subsequently been developed that focus heavily on the Gate Control Theory of pain and work on the principal of contact inhibition, thereby targeting the inhibitory neurons responsible for moderating a pain response to a noxious stimulus. These alternative modalities eliminate the production of parathesia altogether and produce pain relief much more quickly in comparison to traditional systems. This retrospective, single site study will assess the level of pain relief in timed increments following the placement of both the convention SCS system and FAST, helping answer the question of whether these devices have utility in both effectively and expeditiously relieving pain when compared to their traditional counterparts as well as if the treatment paradigm should be shifted to FAST-SCS therapies altogether.
Project Title: A prospective observational study of the frequency of programming changes after the spinal cord stimulation device implant over one year. (POST-FrePASS)
Principal Investigator: Tariq Malik, MD
Overview: SCS therapy has long been used as a suitable alternative to relinquishing pain in those individuals with chronic pain related pathologies. Although clinically useful, there are risks and drawbacks to the procedure which may lead to poor clinical outcomes and/or morbidity related to the procedure itself. One such drawback is the frequency of programming changes required for SCS over a long-term basis to ensure maximum utility and usefulness. The frequency of reprogramming is poorly studied and as a result, an underrepresented and underappreciated component of SCS implantation. This prospective, observational study aims to evaluate the burden associated with frequent programming changes as a reflection of therapy failure as well as to identify factors that may improve patient selection for these devices moving forward.
Project Title: A retrospective chart-review of 9 patients with lumbar radicular pain; comparing neuro-physiologic waveforms in asleep vs. awake patients undergoing percutaneous SCS lead placement.
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Spinal cord stimulator implantation has long been a procedure performed under moderate sedation to allow for the response to verbal and/or tactile stimuli intra-op, thus leading to proper placement of percutaneous leads. This system permits the patient to work in conjunction with the clinician to map out precisely where lead placement is necessitated in order to provide adequate relief of pain. This modality has drawbacks, including (but not limited to) varying levels of sedation leading to the potential complications including improper lead placement and decreased overall success. Other implantation approaches have been created that utilize neurophysiological monitoring as a means of identifying proper lead placement under the use of general anesthesia. Once such approach is known as Compound Muscle Action Potential (CMAP) which operates on the principle of dermatomal/myotomal overlap. This retrospective, single site study aims to evaluate the utility of this overlap mapping method under general anesthesia in comparison to lead placement under moderate sedation and serves to answer the question whether this technique has significant effect on patient outcomes and/or complications as well as act as a tool to help guide clinician decision making regarding the use of these techniques moving forward.
Project Title: Neuromonitoring protocols for percutaneous spinal cord stimulation leads.
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Intra-operative neurophysiological monitoring (IONM) as it relates to SCS implantation operates on the principal of myotomal mapping and the subsequent evaluation of dermatomal overlap using a method known as Compound Muscle Action Potential (CMAP) which is performed under general anesthesia. This process contraries other forms of SCS implantation, which typically only require moderate sedation so that the patient may respond to verbal/tactile stimuli to assist with lead placement for optimal pain relief. CMAP has primarily been achieved using paddles instead of percutaneous leads; what this study aims to analyze is the efficacy of pain relief provided by percutaneous leads in SCS placement using CMAP at specific spinal levels (T7- upper portion of T10) when compared to paddle leads, and assessing if this technique would serve as a suitable alternative to SCS implantation moving forward.
Project Title: Single-center, Observational Pilot Study on the Use of Intra-Operative Neurophysiological Monitoring in Spinal Cord Stimulator Trials.
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: SCS implantation has long been performed under moderate sedation to allow for intra-operative response to stimulation from SCS leads as well as to provide a level of safety in the event of complication. This anesthetic approach has potential drawbacks including, but not limited to, varying levels of sedation as well as patient inability to differentiate pain syndrome from effects of sedation which have led to significant effects on patient outcomes and implant success. Alternative methods have been proposed, including undergoing general anesthesia and utilizing intraoperative neurophysiological monitoring (IONM) to pinpoint myotome coverage of pain which in theory corresponds to dermatomal coverage. One such IONM modality known as Compound Muscle Action Potential (CMAP) has been formulized to reliably map the dermatomal overlap associated with alpha motor neurons in the target muscle. The researchers involved with this study aim to analyze the safety and efficacy of SCS implantation using CMAP in patients with lumbar radiculopathy using percutaneous leads and hope to answer whether or not this technique has the potential to become the mainstay for SCS implantation moving forward when compared to other anesthetic approaches and differing forms of IONM.
Project Title: Single-Center, Observational Study Evaluating the Efficacy and Safety of IV Ketamine vs IV Lidocaine in the Perioperative Setting
Principal Investigator: Maunak Rana, MD
Overview: The use of both Ketamine and Lidocaine in the peri-operative setting has been shown to provide a significant level of analgesia for surgical patients, thereby decreasing the need for opioid pain medications post-operatively and improving post-surgical outcomes. Although operating under differing mechanisms of action, both have proven to be safe and efficacious. What this retrospective study aims to achieve is a thorough analysis of the two medications with the intent of identifying which medication provides a more effective level of pain relief and displays the most favorable safety profile among patients with varying conditions/disease states/co-morbidities. Three patient populations will be scrutinized (sickle cell disease, post-amputation, and post-laparoscopy patients), with the end goal of helping answer the question regarding whether one medication reigns superior among different patient populations as well as to help provide a pathway for clinician decision making moving forward.
Project Title: Retrospective Analysis of Efficacy of Erector spinae catheter and Thoracic Epidural catheter for post-operative management of pain following Nuss procedure
Principal Investigator: Tennison Malcolm, MD
Overview: Procedures involving the correction of Pectus Excavatum, such as the Nuss procedure, have long been used to correct this pathology however result in the onset of severe pain that has proven to be difficult to control. Various treatment modalities have been explored, including PCA pumps and continuous thoracic epidural analgesia (TEA) to assist with relief of this pain, however limited data exists analyzing the utility of other forms of relief such as the Erector Spinae Plane block in comparison to more traditional forms of analgesia. What this retrospective, single site study aims to evaluate is the safety of administration and efficacy of pain relief provided by both TEA and ESP blocks in patients undergoing Pectus Excavatum repair, such as the Nuss procedure, in an attempt to identify which modality may offer the greatest balance amongst safety and postoperative pain management after these procedures. This study will serve as a tool that can best be utilized by pain physicians when handling this type of refractory pain in this setting moving forward.
Project Title: A Single-Center, Retrospective, Observational Chart Review Assessing Efficacy of Vertiflex Procedure in treating Pain Symptoms In Patients with Spinal Stenosis.
Principal Investigator: Magdalena Anitescu, MD PhD
Overview: Spinal stenosis is characterized as the narrowing of spinal canal thereby compressing spinal nerves and/or the cord itself and subsequently producing pain. Classically relieved by passive flexion of the spine, conventional medical management for such a condition range from non-invasive (physical therapy and/or pain medication) to more aggressive forms of relief involving surgery. One technique has been developed that utilizes the implantation of an interspinous process spacer device to provide mechanically supportive spinal flexion to provide pain relief in spinal stenosis as well as preserving the option for surgical management if pain persists. What this retrospective, single site study aims to analyze is the efficacy surrounding the placement of these spacers (known as Vertiflex) and the quantification of pain relief that these devices provide. This study will help shed light on the utility of these therapies and help guide clinical decision making regarding their implantation moving forward.
Project title: Fascia iliaca catheter improves pain in patients with femoral head fractures
Principal Investigator: Tom Xiao, MD
Overview: Patients with femoral head fractures status post falls are usually complaining of significant pain. In many situations, those patients are elderly with significant co-morbidities. The usual treatment of pain in emergency department and on floor is with opioid analgesics with the usual side effects of those types of medications. Following the successful implementation of the fascia iliaca block in the ED, the researchers are investigating the fascia iliaca catheter in efficacy to treat pain and decrease opioid consumption in the perioperative period.
