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JOURNAL ARTICLE
Martijn R Mons, Kenneth B Chapman, Chris Terwiel, Elbert A Joosten, Jan Willem Kallewaard
INTRODUCTION: Chronic discogenic low back pain (CD-LBP) is caused by degenerated disks marked by neural and vascular ingrowth. Spinal cord stimulation (SCS) has been shown to be effective for pain relief in patients who are not responsive to conventional treatments. Previously, the pain-relieving effect of two variations of SCS has been evaluated in CD-LBP: Burst SCS and L2 dorsal root ganglion stimulation (DRGS). The aim of this study is to compare the effectivity in pain relief and pain experience of Burst SCS with that of conventional L2 DRGS in patients with CD-LBP...
May 16, 2023: Neuromodulation: Journal of the International Neuromodulation Society
#22
JOURNAL ARTICLE
Maike H J Schepens, Annemarie C Trompert, Miranda L van Hooff, Erik van der Velde, Marjon Kallewaard, Iris J A M Verberk-Jonkers, Huib A Cense, Diederik M Somford, Sjoerd Repping, Selma C Tromp, Michel W J M Wouters
BACKGROUND: Reuse of health care data for various purposes, such as the care process, for quality measurement, research, and finance, will become increasingly important in the future; therefore, "Collect Once Use Many Times" (COUMT). Clinical information models (CIMs) can be used for content standardization. Data collection for national quality registries (NQRs) often requires manual data entry or batch processing. Preferably, NQRs collect required data by extracting data recorded during the health care process and stored in the electronic health record...
March 2023: Applied Clinical Informatics
#23
JOURNAL ARTICLE
Tjitske D Groenveld, Merlijn L M Smits, Jesper Knoop, Jan Willem Kallewaard, J Bart Staal, Marjan de Vries, Harry van Goor
OBJECTIVES: Low back pain is the leading cause of years lived with disability with a large impact on quality of life and resistant to a broad array of current treatments. This study aims to investigate the effect of a novel self-administered behavioural therapy-based Virtual Reality (VR) application on quality of life of patients with non-specific chronic low back pain (CLBP). METHODS: A pilot randomised controlled trial was conducted in adults with non-specific CLBP with moderate to severe pain, waiting for treatment in a teaching hospital-based pain clinic...
April 1, 2023: Clinical Journal of Pain
#24
LETTER
Simon Thomson, Jan Willem Kallewaard, Kliment Gatzinsky
No abstract text is available yet for this article.
March 14, 2023: JAMA
#25
JOURNAL ARTICLE
Richard L Rauck, Eric Loudermilk, Simon J Thomson, Jose Francisco Paz-Solis, Louis Bojrab, John Noles, Jan Vesper, Joseph Atallah, Daniel Roth, Joseph Hegarty, Michel Prud'Homme, Gregory M Phillips, Stephen G Smith, Mohab Ibrahim, Channing D Willoughby, Jon B Obray, Mayank Gupta, Julio Paez, Anthony P Berg, Nathan J Harrison, Paolo Maino, Praveen Mambalam, Matthew McCarty, Glyn Towlerton, Sarah Love-Jones, Shakil Ahmed, Albert Lee, Binit Shah, Itay Goor-Aryeh, Marc A Russo, Nicolas Varela, Jeffrey B Phelps, José Cid, Tacson Fernandez, Concepción Pérez-Hernández, Douglas Keehn, Joshua M Rosenow, Nameer Haider, Andrew G Parrent, Melinda M Lawrence, Peter Georgius, Laura Demartini, Agustin Mendiola, Vivek Mehta, Reinhard Thoma, Atef F Israel, Giuliano De Carolis, Sanjay Bhatia, Matthew Green, Armando Villarreal, Matthew T Crooks, Ryder P Gwinn, Julie G Pilitsis, Hitoaki Sato, Sergio Maldonado Vega, M Gabriel Hillegass, Paul Carnes, Christian Scherer, Silviu Brill, James Yu, James J Brennan, Kliment Gatzinsky, Annu Navani, Lee T Snook, Borja Mugabure Bujedo, Javier De Andrés Ares, Abel Murillo, Andrew T Trobridge, Kamyar Assil, Jawad Shah, Carroll McLeod, Joseph Buwembo, Olivier De Coster, Nathan Miller, Mehendra Sanapati, Medhat Mikhael, Rene Przkora, Norihiko Sukenaga, Louis J Raso, Aaron K Calodney, Luz Elena Cáceres Jerez, Takuya Uchiyama, Jan-Willem Kallewaard, Brett Chandler, Fabián Piedimonte, Kenneth D Candido, Tristan E Weaver, Takashi Agari, David Holthouse, Rex Woon, Nileshkumar Patel, Kristen Lechleiter, Roshini Jain
Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief...
January 24, 2023: Pain Management
#26
RANDOMIZED CONTROLLED TRIAL
Thibaut Vanneste, Amy Belba, Jan Willem Kallewaard, Sander M J van Kuijk, Marloes Gelissen, Peter Emans, Johan Bellemans, Kristof Smeets, Chris Terwiel, Koen Van Boxem, Micha Sommer, Jan Van Zundert
BACKGROUND: Radiofrequency (RF) treatment of the genicular nerves has the potential to reduce chronic knee pain due to osteoarthritis or persistent postsurgical pain, however, a direct comparison between the two main modalities used, conventional and cooled, is lacking. METHODS: This double blind, non-inferiority, pilot, randomized controlled trial compared the effects of cooled and conventional RF in chronic knee pain patients suffering from osteoarthritis or persistent postsurgical pain after total knee arthroplasty...
May 2023: Regional Anesthesia and Pain Medicine
#27
JOURNAL ARTICLE
Robert M Levy, Nagy Mekhail, Alaa Abd-Elsayed, David Abejón, Magdalena Anitescu, Timothy R Deer, Sam Eldabe, Lisa Goudman, Jan W Kallewaard, Maarten Moens, Erika A Petersen, Julie G Pilitsis, Jason E Pope, Lawrence Poree, Ahmed M Raslan, Marc Russo, Dawood Sayed, Peter S Staats, Rod S Taylor, Simon Thomson, Paul Verrills, Rui V Duarte
BACKGROUND: Treatment response to spinal cord stimulation (SCS) is focused on the magnitude of effects on pain intensity. However, chronic pain is a multidimensional condition that may affect individuals in different ways and as such it seems reductionist to evaluate treatment response based solely on a unidimensional measure such as pain intensity. AIM: The aim of this article is to add to a framework started by IMMPACT for assessing the wider health impact of treatment with SCS for people with chronic pain, a "holistic treatment response"...
January 3, 2023: Neuromodulation: Journal of the International Neuromodulation Society
#28
JOURNAL ARTICLE
Andrew Dippel, Austin Gallegos, Vineela Aleti, Arnita Barnes, Xiaoru Chen, Elizabeth Christian, Jared Delmar, Qun Du, Reza Esfandiary, Erika Farmer, Andrew Garcia, Qing Li, Jia Lin, Weiyi Liu, LeeAnn Machiesky, Neil Mody, Arun Parupudi, Meagan Prophet, Keith Rickert, Kim Rosenthal, Song Ren, Harini Shandilya, Reena Varkey, Kevin Wons, Yuling Wu, Yueh-Ming Loo, Mark T Esser, Nicole L Kallewaard, Sarav Rajan, Melissa Damschroder, Weichen Xu, Gilad Kaplan
To combat the COVID-19 pandemic, potential therapies have been developed and moved into clinical trials at an unprecedented pace. Some of the most promising therapies are neutralizing antibodies against SARS-CoV-2. In order to maximize the therapeutic effectiveness of such neutralizing antibodies, Fc engineering to modulate effector functions and to extend half-life is desirable. However, it is critical that Fc engineering does not negatively impact the developability properties of the antibodies, as these properties play a key role in ensuring rapid development, successful manufacturing, and improved overall chances of clinical success...
2023: MAbs
#29
JOURNAL ARTICLE
Frédérique Mol, Marc Scheltinga, Rudi Roumen, Frank Wille, Ismail Gültuna, Jan-Willem Kallewaard, Lars Elzinga, Johan van de Minkelis, Harold Nijhuis, Dirk L Stronks, Frank J P M Huygen
OBJECTIVES: Approximately 10% of patients who undergo inguinal hernia repair or Pfannenstiel incision develop chronic (> three months) postsurgical inguinal pain (PSIP). If medication or peripheral nerve blocks fail, a neurectomy is the treatment of choice. However, some patients do not respond to this treatment. In such cases, stimulation of the dorsal root ganglion (DRG) appears to significantly reduce chronic PSIP in selected patients. MATERIALS AND METHODS: In this multicenter, randomized controlled study, DRG stimulation was compared with conventional medical management (CMM) (noninvasive treatments, such as medication, transcutaneous electric neurostimulation, and rehabilitation therapy) in patients with PSIP that was resistant to a neurectomy...
November 28, 2022: Neuromodulation: Journal of the International Neuromodulation Society
#30
JOURNAL ARTICLE
Martijn R Mons, Kenneth B Chapman, Chris Terwiel, Elbert A Joosten, Jan-Willem Kallewaard
INTRODUCTION: Chronic discogenic low back pain (CD-LBP) is caused by degeneration of the disc due to trauma to the annulus or by unprovoked degeneration, resulting in chronic pain. Spinal cord stimulation (SCS) employing the BurstDR™ waveform has been shown to be an effective treatment in a variety of chronic pain conditions. The aim of this prospective case study was to determine the effect of BurstDR™ SCS on pain relief, disability, and patient satisfaction in a population with CD-LBP...
March 2023: Pain Practice: the Official Journal of World Institute of Pain
#31
JOURNAL ARTICLE
Martijn R Mons, Caro Edelbroek, Xander Zuidema, Katja Bürger, Lars Elzinga, Jessica de Vries, Sander van Kuijk, Elbert A Joosten, Jan-Willem Kallewaard
BACKGROUND: Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Within burst stimulation, a recharge pattern is used to prevent buildup of charge in stimulated tissues. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It has been suggested that differences exist between active and passive recharge paradigms related to both efficacy of pain relief and their underlying mechanism of action...
September 5, 2022: Trials
#32
JOURNAL ARTICLE
Simon Thomson, Nicky Helsen, Simon Prangnell, Mery Paroli, Ganesan Baranidharan, Hayat Belaïd, Bart Billet, Sam Eldabe, Giuliano De Carolis, Laura Demartini, Kliment Gatzinsky, Jan Willem Kallewaard, Matthias Winkelmüller, Frank Huygen, Herman Stoevelaar
BACKGROUND: A previously developed educational e-health tool considers both clinical and psychosocial factors when selecting patients with chronic pain for spinal cord stimulation (SCS). The validity of the composite recommendations was evaluated in a retrospective study, demonstrating a strong relationship with patient outcomes after SCS. METHODS: An additional retrospective analysis was performed to determine the added value of a psychosocial evaluation as part of the decision-making process on SCS...
October 2022: European Journal of Pain: EJP
#33
RANDOMIZED CONTROLLED TRIAL
Robert J Benschop, Jay L Tuttle, Lin Zhang, Josh Poorbaugh, Nicole L Kallewaard, Peter Vaillancourt, Melissa Crisp, Thi Ngoc Vy Trinh, Joshua J Freitas, Stephanie Beasley, Montanea Daniels, Natalie Haustrup, Richard E Higgs, Ajay Nirula, Myron S Cohen, Mary Marovich
As the coronavirus disease 2019 (COVID-19) pandemic evolves and vaccine rollout progresses, the availability and demand for monoclonal antibodies for the prevention and treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are also accelerating. This longitudinal serological study evaluated the magnitude and potency of the endogenous antibody response to COVID-19 vaccination in participants who first received a COVID-19 monoclonal antibody in a prevention study. Over the course of 6 months, serum samples were collected from a population of nursing home residents and staff enrolled in a clinical trial who were randomized to either bamlanivimab treatment or placebo...
July 27, 2022: Science Translational Medicine
#34
JOURNAL ARTICLE
Rod S Taylor, Nicole Soliday, Angela Leitner, Corey W Hunter, Peter S Staats, Sean Li, Simon Thomson, Jan W Kallewaard, Marc Russo, Rui V Duarte
OBJECTIVES: Pain score, functional disability, and health-related quality of life (HRQoL) are core outcome domains for chronic pain clinical trials. Although greater levels of pain reduction have been shown to be linked to larger gains in HRQoL, little is known of the association between HRQoL and disability in the setting of chronic pain. The aims of this study were to 1) investigate the association between functional disability and HRQoL and 2) estimate the utility values associated with levels of functional disability in patients treated with evoked compound action potential (ECAP) spinal cord stimulation (SCS) for chronic pain...
May 25, 2022: Neuromodulation: Journal of the International Neuromodulation Society
#35
JOURNAL ARTICLE
Kathryn Westendorf, Stefanie Žentelis, Lingshu Wang, Denisa Foster, Peter Vaillancourt, Matthew Wiggin, Erica Lovett, Robin van der Lee, Jörg Hendle, Anna Pustilnik, J Michael Sauder, Lucas Kraft, Yuri Hwang, Robert W Siegel, Jinbiao Chen, Beverly A Heinz, Richard E Higgs, Nicole L Kallewaard, Kevin Jepson, Rodrigo Goya, Maia A Smith, David W Collins, Davide Pellacani, Ping Xiang, Valentine de Puyraimond, Marketa Ricicova, Lindsay Devorkin, Caitlin Pritchard, Aoise O'Neill, Kush Dalal, Pankaj Panwar, Harveer Dhupar, Fabian A Garces, Courtney A Cohen, John M Dye, Kathleen E Huie, Catherine V Badger, Darwyn Kobasa, Jonathan Audet, Joshua J Freitas, Saleema Hassanali, Ina Hughes, Luis Munoz, Holly C Palma, Bharathi Ramamurthy, Robert W Cross, Thomas W Geisbert, Vineet Menachery, Kumari Lokugamage, Viktoriya Borisevich, Iliana Lanz, Lisa Anderson, Payal Sipahimalani, Kizzmekia S Corbett, Eun Sung Yang, Yi Zhang, Wei Shi, Tongqing Zhou, Misook Choe, John Misasi, Peter D Kwong, Nancy J Sullivan, Barney S Graham, Tara L Fernandez, Carl L Hansen, Ester Falconer, John R Mascola, Bryan E Jones, Bryan C Barnhart
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-neutralizing monoclonal antibodies (mAbs) can reduce the risk of hospitalization from coronavirus disease 2019 (COVID-19) when administered early. However, SARS-CoV-2 variants of concern (VOCs) have negatively affected therapeutic use of some authorized mAbs. Using a high-throughput B cell screening pipeline, we isolated LY-CoV1404 (bebtelovimab), a highly potent SARS-CoV-2 spike glycoprotein receptor binding domain (RBD)-specific antibody. LY-CoV1404 potently neutralizes authentic SARS-CoV-2, B...
April 25, 2022: Cell Reports
#36
REVIEW
Caro T M Edelbroek, Jan Willem Kallewaard, Inge D'eer, Erkan Kurt, Harold J A Nijhuis, Chris T M Terwiel, Tom W G van de Voort, Gusta M de Vries-Fennis, Jitske Tiemensma, Frank Huygen
INTRODUCTION: After an interpretation trajectory, the Dutch Quality of Healthcare Institute recommended that for five indications, spinal cord stimulation, dorsal root ganglion stimulation, or occipital nerve stimulation, together referred to as neurostimulation, can be considered effective and be reimbursed in the Netherlands. These five indications are the well and largely studied, accepted neurostimulation indications in scientific literature. As an extension of this, all the scientific societies involved in the Netherlands were required to reach a consensus about the diagnosis and treatment of these five formulated indications to describe the place of neurostimulation within the treatment algorithm...
May 10, 2022: Neuromodulation: Journal of the International Neuromodulation Society
#37
JOURNAL ARTICLE
Merlijn Smits, Harry van Goor, Jan-Willem Kallewaard, Peter-Paul Verbeek, Geke D S Ludden
Value Sensitive Design (VSD) is the most well-known method to consider values in design. It consists of three iterative phases of investigation: conceptual, empirical, and technical. Although the approach is promising, the role of empirical research remains unclear. We address two opportunities for extending the role of empirical research in VSD. First, we argue that empirical research enables us to identify values in context. Second, we explain that empirical research enables us to anticipate how technology mediates the values of users...
April 29, 2022: Health and Technology
#38
JOURNAL ARTICLE
Kenneth B Chapman, Ajax Yang, Alon Y Mogilner, Nataniel Mandelberg, Kiran V Patel, Timothy Lubenow, Timothy Deer, Jan Willem Kallewaard, Noud van Helmond
INTRODUCTION: Dorsal root ganglion stimulation (DRG-S) is a relatively new neuromodulation modality. Therefore, data on long-term device explantation rates is limited. This investigation aimed to assess DRG-S device explantation rates at long-term follow-up. METHODS: We retrospectively reviewed individuals implanted with DRG-S in four pain centers from different continuous periods between April 2016 to September 2020. We recorded patient demographics, diagnoses, duration to explantation or last follow-up, treatment complications, and failure etiologies...
April 16, 2022: Pain Practice: the Official Journal of World Institute of Pain
#39
JOURNAL ARTICLE
Kenneth B Chapman, Noud van Helmond, Jan Willem Kallewaard, Kris C Vissers, Kiran V Patel, Soriaya Motivala, Jonathan M Hagedorn, Timothy R Deer, David M Dickerson
OBJECTIVE: A heightened and organized understanding of sacral anatomy could potentially lead to a more effective and safe method of dorsal root ganglion stimulation (DRG-S) lead placement. The aim of this technical note is to describe a standardized access method for S1 DRG-S lead placement. DESIGN: Technical note. METHODS: The described approach utilizes alignment of the lumbosacral prominence and is measurement-based, allowing for standardized sacral access, even when visualization is suboptimal...
September 30, 2022: Pain Medicine
#40
JOURNAL ARTICLE
Eva Koetsier, Sander M J van Kuijk, Paolo Maino, Jasmina Dukanac, Luca Scascighini, Alessandro Cianfoni, Pietro Scarone, Dominique E Kuhlen, Markus W Hollman, Jan-Willem Kallewaard
INTRODUCTION: Discogenic pain is the cause of pain in 26%-40% of patients with for low back pain. Consensus about treatment of chronic discogenic low back pain is lacking and most treatment alternatives are supported by limited evidence. The percutaneous implantation of hydrogels into the nucleus pulposus represents a promising regenerative intradiscal therapy. The hydrogel 'GelStix' is composed primarily of hydrolyzed polyacrylonitrile and acts as a reservoir of hydration, producing increased pressure and improved pH balance, potentially leading to disc preservation...
March 30, 2022: BMJ Open
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