Wearable Textile with Integrated Electrotherapy and Sensing for Joint Pain Management

骨关节炎（OA）是最常见的肌肉骨骼疾病，膝关节OA是最常见的。预计到2035年，英国膝关节OA患者将从470万增加到830万。膝关节疼痛通常会降低身体活动、独立性和生活质量。目前，膝关节OA疼痛是通过药物（非甾体抗炎药/阿片类药物）治疗的，每年花费1.953亿英镑。然而，药物可能会导致严重的副作用。无法控制的疼痛最终可能需要关节置换术。2019年进行了106572例膝关节置换术，其中98%是由于膝关节OA，在英国每年花费约8亿英镑。该项目旨在开发一种基于可穿戴服装的电疗产品，通过经皮神经电刺激（TENS）缓解膝关节OA疼痛，并通过肌肉电刺激（EMS）锻炼肌肉。集成在服装中的传感纱线将准确监测关节运动，为用户提供实时反馈。TENS/EMS电极和传感纱线将集成到日常使用的谨慎和美观的服装中。该产品将由无线控制器单元控制。一个应用程序将允许用户访问他们的治疗数据，监控进度，记录反馈，并与医疗保健专业人员远程沟通。该产品将允许用户随时随地管理他们的疼痛和锻炼肌肉。这将带来更好的患者治疗结果，同时降低医疗成本。这个项目建立在我们之前成功的可行性研究的基础上，包括一种集成电极的纺织品，用于缓解疼痛和肌肉刺激，以及一种用于运动监测的传感纺织品以及相关的电子设备。早期阶段的TENS原型已经与膝关节OA患者和医疗保健专业人员共同设计和测试。用户测试结果表明，疼痛减轻，易于使用和用户舒适。通过公众和患者参与以及用户测试收集的反馈为本提案中针对产品的设计提供了信息。产品将与最终用户共同开发，最终用户将迭代地反馈他们的用户需求和测试原型。分包商将支持以用户为中心的设计和可扩展制造工艺的开发，以实现市场适应和批量生产。将进行家庭可用性测试，以确保产品适合在家庭环境中独立使用。将进行一项试点随机对照试验（RCT），以确定疼痛管理的有效性，并为未来的最终RCT提供信息。将开发ISO13485质量管理体系和技术文件，以证明符合英国和欧盟医疗器械法规。我们将传播研究成果，并与利益相关者合作，促进技术的采用，以获得产品的经济和社会效益。

Osteoarthritis (OA) is the most common musculoskeletal condition, with knee OA being the most prevalent. People with knee OA in the UK are predicted to increase from 4.7 to 8.3 million by 2035. Knee joint pain typically reduces physical activity, independence, and quality of life. Currently knee OA pain is managed by medication (NSAIDs/opioids) which costs £195.3 million per annum. However, medication may cause serious side effects. Uncontrolled pain ultimately may necessitate joint arthroplasty. 106,572 primary knee replacements were performed in 2019, 98% of which resulted from knee OA, costing ~£800 million per annum in the UK. This project aims to develop an electrotherapy product, based on a wearable garment, to relieve knee OA pain through transcutaneous electrical nerve stimulation (TENS), and exercise muscles through electrical muscle stimulation (EMS). Sensing yarns integrated into the garment will accurately monitor joint movements providing users with real-time feedback. The TENS/EMS electrodes and sensing yarn will be integrated into a discreet and aesthetic garment for everyday use. The product will be controlled by a wireless controller unit. An app will allow the user to access their treatment data and monitor progress, record feedback, and communicate with healthcare professionals remotely. The product will allow users to manage their pain and exercise muscles wherever and whenever required. This will lead to better patient outcomes while reducing healthcare costs. This project builds on our previous successful feasibility studies of a textile with integrated electrodes for pain relief and muscle stimulation, and a sensing textile for movement monitoring together with the associated electronics. Early-stage TENS prototypes have been co-designed and tested with people with knee OA and healthcare professionals. User test results have demonstrated pain reduction, ease of use and user comfort. The feedback collected through public and patient engagement and user testing has informed the design of the product targeted in this proposal. The product will be co-developed with end users who will iteratively feedback their user requirements and test prototypes. Subcontractors will support user-centred design and the development of scalable manufacturing process to achieve market fit and volume production. A home usability test will be conducted to ensure the product is suitable for independent use in the home environment. A pilot Randomized Controlled Trial (RCT) will be conducted to establish efficacy in pain management and inform a future definitive RCT. An ISO13485 Quality Management System and technical documentation will be developed to demonstrate compliance with UK and EU Medical Device Regulations. We will disseminate the research outcomes and engage stakeholders to promote technology uptake in order to capture the economic and societal benefits of the product.