Ullah, Irfan, Ward, Tyler, Greig, Tom, Lake-Thompson, Gillian, Liu, Meijing, Reeves, Lynn, Dennison, Elaine, Tudor, John and Yang, Kai (2026) A wearable TENS garment for joint pain management: IEC 60601 compliant design and preliminary evaluation. IEEE Journal of Translational Engineering in Health and Medicine, 14, 91-103. (doi:10.1109/JTEHM.2026.3663967).
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.
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