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.