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

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.