A Wearable TENS Garment for Joint Pain Management: IEC 60601 Compliant Design and Preliminary Evaluation

IF 4.4 3区医学 Q2 ENGINEERING, BIOMEDICAL

IEEE Journal of Translational Engineering in Health and Medicine-Jtehm Pub Date : 2026-02-11 DOI:10.1109/JTEHM.2026.3663967

Irfan Ullah;Tyler Ward;Tom Greig;Gillian Lake-Thompson;Meijing Liu;Lynn Reeves;Elaine Dennison;John Tudor;Kai Yang

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引用次数: 0

Abstract

Objectives: To develop and evaluate a wearable, garment-integrated transcutaneous electrical nerve stimulation (TENS) system for relieving osteoarthritis knee pain, emphasizing safety, usability, and readiness for home and clinical deployment.Methods: We designed an IEC 60601 compliant TENS system that embeds flexible electrodes into a close-fitting, machine-washable textile. A seven-day, home-based usability evaluation was conducted with 11 participants with osteoarthritis. Outcomes included self-reported pain (baseline vs. post-use) and usability metrics (ease of setup and comfort). The system received Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) approvals for a subsequent clinical investigation.Results: Participants reported strong user acceptance, ease of use and comfort. Average pain decreased by 54.79% over the evaluation period, indicating a meaningful short-term analgesic benefit in a home setting. No serious adverse events were observed.Conclusion: Integrating electrodes into a wearable garment addresses key limitations of conventional adhesive-pad TENS, improving placement consistency, comfort, and ease of use while supporting safe operation under IEC 60601. These preliminary findings support the feasibility of garment-based TENS for osteoarthritis management at home and justify a follow-on clinical trial to rigorously quantify pain relief, functional outcomes, and user satisfaction in a larger cohort. Clinical Impact: The use of a washable TENS garment, compliant with IEC 60601, resulted in reduced osteoarthritis pain in a home setting. Its integration into home care is facilitated by an easy to use device with reusable textile electrodes

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用于关节疼痛管理的可穿戴TENS服装：符合IEC 60601的设计和初步评估

目的：开发和评估一种可穿戴的、服装集成的经皮神经电刺激（TENS）系统，用于缓解骨关节炎膝关节疼痛，强调安全性、可用性，并为家庭和临床部署做好准备。方法：我们设计了一个符合IEC 60601标准的TENS系统，该系统将柔性电极嵌入到贴身的可机洗纺织品中。对11名患有骨关节炎的参与者进行了为期7天的家庭可用性评估。结果包括自我报告的疼痛（基线与使用后）和可用性指标（安装的便利性和舒适度）。该系统获得了药品和保健产品监管机构（MHRA）和健康研究管理局（HRA）的批准，可以进行后续的临床研究。结果：参与者报告了较强的用户接受度、易用性和舒适性。在评估期间，平均疼痛减少了54.79%，表明在家庭环境中有意义的短期镇痛效益。未观察到严重不良事件。结论：将电极集成到可穿戴服装中，解决了传统黏贴式TENS的主要局限性，提高了放置的一致性、舒适性和易用性，同时支持IEC 60601标准下的安全操作。这些初步研究结果支持了基于服装的TENS用于骨关节炎家庭治疗的可行性，并证明了后续临床试验的合理性，以严格量化更大队列的疼痛缓解、功能结果和用户满意度。临床影响：使用符合IEC 60601标准的可洗TENS服装，减少了家庭环境中的骨关节炎疼痛。它集成到家庭护理是由一个易于使用的设备与可重复使用的纺织电极

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来源期刊

IEEE Journal of Translational Engineering in Health and Medicine-Jtehm Engineering-Biomedical Engineering

CiteScore

7.40

自引率

2.90%

发文量

审稿时长

27 weeks

期刊介绍： The IEEE Journal of Translational Engineering in Health and Medicine is an open access product that bridges the engineering and clinical worlds, focusing on detailed descriptions of advanced technical solutions to a clinical need along with clinical results and healthcare relevance. The journal provides a platform for state-of-the-art technology directions in the interdisciplinary field of biomedical engineering, embracing engineering, life sciences and medicine. A unique aspect of the journal is its ability to foster a collaboration between physicians and engineers for presenting broad and compelling real world technological and engineering solutions that can be implemented in the interest of improving quality of patient care and treatment outcomes, thereby reducing costs and improving efficiency. The journal provides an active forum for clinical research and relevant state-of the-art technology for members of all the IEEE societies that have an interest in biomedical engineering as well as reaching out directly to physicians and the medical community through the American Medical Association (AMA) and other clinical societies. The scope of the journal includes, but is not limited, to topics on: Medical devices, healthcare delivery systems, global healthcare initiatives, and ICT based services; Technological relevance to healthcare cost reduction; Technology affecting healthcare management, decision-making, and policy; Advanced technical work that is applied to solving specific clinical needs.