Wayville

This research aims to evaluate a new delivery method of spinal cord stimulation using the Evoke System for patients with chronic pain in the trunk andor limbs. The study focuses on a novel approach called ECAP-controlled closed-loop spinal cord stimulation, which includes new software and hardware features to better manage pain. The trial is designed as a prospective, multicenter, single-arm feasibility study sponsored by Saluda Medical Pty Ltd. Participants will receive treatment with the Evoke Spinal Cord Stimulation SCS System, which continuously measures and records evoked compound action potentials ECAPs and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. This closed-loop system aims to provide a more personalized and controlled pain management experience. The study includes only one experimental treatment group using this device. During the study, participants will be closely monitored for changes in ECAPs as measured by the Evoke SCS System through the completion of the study, which can last up to two years. Assessments will focus on the devices performance in controlling pain signals, with ongoing evaluations to track the stability and effectiveness of the stimulation. Participants will provide informed consent and comply with study requirements throughout their involvement.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

Researchers are conducting a global, prospective, multi-center observational study to gather real-world data on the long-term effectiveness, economic value, and technical performance of Boston Scientifics commercially approved neurostimulation systems for pain management. The study focuses on patients using these neurostimulation devices according to their approved instructions for use in routine clinical practice. Participants will first undergo a neurostimulation trial period using any commercially approved Boston Scientific neurostimulator for pain. Those who experience a positive outcome from this trial may then receive a permanent implant of the neurostimulation system. Treatment customization will be guided by the investigators judgment and routine care practices at each site. During the study, participants will be observed to collect information on clinical outcomes, technical device performance, and economic factors related to neurostimulation therapy. The research team will monitor participants over the long term to assess how well the therapy manages pain and its associated benefits. The study is expected to continue until May 2035, with ongoing follow-up and data collection throughout this period.

Researchers are evaluating whether Ultra Low Frequency ULF neuromodulation can reduce chronic nociceptive low back pain in adults and assessing its safety compared to conventional medical management CMM. This prospective, multi-center, randomized controlled trial focuses on adults with chronic, intractable axial low back pain with prominent nociceptive features, aiming to understand if ULF therapy offers better pain relief and any unexpected medical issues over 24 months. Participants will be randomly assigned in a 21 ratio to either receive ULF therapy combined with CMM or CMM alone. Those in the ULF group will first undergo a temporary trial phase and may receive a permanent implant if they experience at least 50% pain relief. At six months, participants can choose to switch to the other treatment if eligible. The primary outcome, back pain relief measured by a visual analog scale VAS, will be evaluated at three months with continued follow-up for a total of 24 months. During the study, participants will attend regular clinic visits for checkups and data collection. Researchers will assess pain levels, functional improvement, disability, opioid use, and quality of life using various tools including VAS and the Oswestry Disability Index ODI. Safety and treatment effects will be monitored over the entire two-year period to provide comprehensive information about ULF neuromodulation compared to standard care.