In routine clinical care, up to 50% of patients with neuropathic pain fail to obtain pain relief from analgesic medicines. Health-related quality of life is significantly poorer in people with chronic pain than in those without, and poorer in people with neuropathic pain than in those with non-neuropathic pain. Registered on 15 August 2017.Īpproximately 20% of the adult European population has significant chronic pain, and 7–8% of the population has chronic pain with neuropathic features. The nested qualitative study will seek to explore the patient’s view of the screening trials, implantation and overall use of SCS. The TRIAL-STIM Study is a randomised controlled trial with a nested qualitative study and economic evaluation aiming to determine the clinical utility of screening trials of SCS as well as their cost-effectiveness. The economic evaluation will take the form of a cost–utility analysis. A nested qualitative study will be carried out in parallel for a total of 30 of the patients recruited in each centre (10 at each centre) to explore their views of the screening trial, implantation and overall use of the SCS device. Secondary outcome measures will include diagnostic accuracy, the proportion of patients achieving at least 50% and 30% pain relief at 6 months as measured on the NRS, health-related quality-of-life (EQ-5D), function (Oswestry Disability Index), patient satisfaction (Patients’ Global Impression of Change) and complication rates. The primary outcome measure is the numerical rating scale (NRS) at 6 months compared between the screening trial and implantation strategy and the implantation-only strategy. Allocation will be stratified by centre and minimised on patient age (≥ 65 or < 65 years), gender, presence of failed back surgery syndrome (or not) and use of high frequency (HF10™) (or not). Subjects will be recruited from the outpatient clinics of the three participating sites and randomised to undergo a screening trial prior to SCS implant or an implantation-only strategy in a 1:1 ratio. A total of 100 adults undergoing SCS implantation for the treatment of neuropathy will be included. The study will take place in three UK centres: South Tees Hospitals NHS Foundation Trust (The James Cook University Hospital) Basildon and Thurrock University Hospitals NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust. The TRIAL-STIM Study is a superiority, parallel-group, three-centre, randomised controlled trial in patients with chronic neuropathic pain with a nested qualitative study and economic evaluation. Peripheral Neuropathy: Nerve damage leading to pain and numbness in the extremities.The TRIAL-STIM Study aims to assess the diagnostic performance, clinical outcomes and cost-effectiveness of a screening trial prior to full implantation of a spinal cord stimulation (SCS) device. Ischemic Pain: Pain resulting from inadequate blood supply to tissues. Neuropathic Pain: Pain caused by damage or dysfunction of the nervous system. Some of the common conditions include:įailed Back Surgery Syndrome (FBSS): A condition characterized by persistent pain following spinal surgery.Ĭomplex Regional Pain Syndrome (CRPS): A chronic pain condition affecting limbs, often triggered by injury or surgery. Medtronic Spinal Cord Stimulators are primarily used to treat chronic pain conditions that have not responded well to other conservative treatments. This mechanism helps patients manage their pain and improve their overall quality of life. When activated, the stimulator sends electrical pulses to the spinal cord, modifying or blocking pain signals before they reach the brain. The stimulator is a small, implantable device resembling a pacemaker, while the leads are thin wires connected to the stimulator and placed along the spinal cord. The device consists of two main components: the stimulator and the leads. This process, known as neurostimulation, disrupts the pain signals traveling to the brain, providing relief to individuals suffering from persistent pain conditions. In this page, we will explore what a SCS is, its purpose, the conditions it treats, and address some frequently asked questions about the procedure and its functionality.Ī Spinal Cord Stimulator is a medical device designed to alleviate chronic pain by delivering mild electrical impulses to the spinal cord. Fortunately, advancements in medical technology have paved the way for innovative solutions, and one such breakthrough is the Spinal Cord Stimulator (SCS). Living with chronic pain can be a debilitating experience, affecting every aspect of one's life. Empowering Lives: Understanding Spinal Cord Stimulators and Their Impact on Chronic Pain
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