A Wearable TENS harment for joint pain management: IEC 60601 compliant design and preliminary evaluation
A Wearable TENS harment 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.
Clinical Trial, E-textiles, Electrode, Electrotherapy, Home Usability, IEC 60601 Compliance, Joint Pain, MHRA, Osteoarthritis, Pain Management, Transcutaneous Electrical Nerve Stimulation (TENS), Wearable Medical Devices
91-103
Ullah, Irfan
15653bbb-6bcc-4f9e-b1af-54145ad92cdb
Ward, Tyler
42223a20-f8bd-4299-9e87-5d980dadabf1
Greig, Tom
d54c6aa7-3583-41fa-88b0-d339f06a3fb9
Lake-Thompson, Gillian
34761ab6-f01c-4a0d-949d-aba93910c39f
Liu, Meijing
dd60f1ad-c8c0-482f-bba4-891b3f1f3b0d
Reeves, Lynn
63ffcd8c-34db-4668-8fb3-0dde9e626ace
Dennison, Elaine
ee647287-edb4-4392-8361-e59fd505b1d1
Tudor, John
46eea408-2246-4aa0-8b44-86169ed601ff
Yang, Kai
f1c9b81d-e821-47eb-a69e-b3bc419de9c7
11 February 2026
Ullah, Irfan
15653bbb-6bcc-4f9e-b1af-54145ad92cdb
Ward, Tyler
42223a20-f8bd-4299-9e87-5d980dadabf1
Greig, Tom
d54c6aa7-3583-41fa-88b0-d339f06a3fb9
Lake-Thompson, Gillian
34761ab6-f01c-4a0d-949d-aba93910c39f
Liu, Meijing
dd60f1ad-c8c0-482f-bba4-891b3f1f3b0d
Reeves, Lynn
63ffcd8c-34db-4668-8fb3-0dde9e626ace
Dennison, Elaine
ee647287-edb4-4392-8361-e59fd505b1d1
Tudor, John
46eea408-2246-4aa0-8b44-86169ed601ff
Yang, Kai
f1c9b81d-e821-47eb-a69e-b3bc419de9c7
Ullah, Irfan, Ward, Tyler, Greig, Tom, Lake-Thompson, Gillian, Liu, Meijing, Reeves, Lynn, Dennison, Elaine, Tudor, John and Yang, Kai
(2026)
A Wearable TENS harment for joint pain management: IEC 60601 compliant design and preliminary evaluation.
IEEE Journal of Translational Engineering in Health and Medicine, 14, .
(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.
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.
Text
A_Wearable_TENS_Garment_for_Joint_Pain_Management_IEC_60601_Compliant_Design_and_Preliminary_Evaluation
- Version of Record
More information
Accepted/In Press date: 5 February 2026
Published date: 11 February 2026
Additional Information:
© 2026 The Authors.
Keywords:
Clinical Trial, E-textiles, Electrode, Electrotherapy, Home Usability, IEC 60601 Compliance, Joint Pain, MHRA, Osteoarthritis, Pain Management, Transcutaneous Electrical Nerve Stimulation (TENS), Wearable Medical Devices
Identifiers
Local EPrints ID: 510343
URI: http://eprints.soton.ac.uk/id/eprint/510343
PURE UUID: 53c18754-0375-46d8-a09d-0683152d81be
Catalogue record
Date deposited: 26 Mar 2026 18:01
Last modified: 27 Mar 2026 03:09
Export record
Altmetrics
Contributors
Author:
Irfan Ullah
Author:
Tyler Ward
Author:
Tom Greig
Author:
Gillian Lake-Thompson
Author:
Meijing Liu
Author:
Lynn Reeves
Author:
John Tudor
Download statistics
Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.
View more statistics