The DZero product is a new smart fabric containing nanoceramic particles printed on non-compressive elastic fabric, with valuable biomedical and biophysical properties designed to improve human health. It is a non-commercialized, non-invasive medical device that does not release substances onto or into the human body, but achieves its intended use by exploiting body energy. DZero, associated with the manufacturer Noivita s.r.l.s. falls within the category of Class I Medical Devices and is also included in the section ("Miscellaneous Equipment for Physiotherapy and Rehabilitation") in the official database of the Italian Ministry of Health. As a Class I medical device, the manufacturer does not need to involve a notified body for CE marking in the process of demonstrating compliance with the requirements of the MDR, but is itself responsible for issuing the EC declaration of conformity in accordance with Article 19 of the MDR 2017/745, after carrying out the appropriate checks.

Each person who agreed to participate was given a DZero garment in the form of a T-shirt suitable for their size, so that the garment would fit snugly to the patient's body. The delivery was made by the principal investigator or a specially designated collaborator, who were directly supplied with T-shirts by the Promoter in collaboration with the study manufacturer, who is the direct supplier. The T-shirt was worn for 8 consecutive hours to best express the intrinsic properties related to its components, namely reducing inflammatory conditions and improving muscle tone using body heat. The innovation lies in the engineering of a new smart fabric that, for the first time, integrates nanoceramics and postural structure, exploiting the characteristics of both materials (bioceramics and fabric) to provide significant benefits for improving health and quality of life on a daily basis.

Measuring quality of life, described with the EURO-QoL-5D-5L or EQ-5D-5L. The instrument consists of: a 5-dimensional descriptive system (mobility, self-care ability, habitual activities, pain/discomfort, and anxiety/depression), each of which involves a three-point rating scale (no problem=1 point; some problem=2 points; persistent problem=3 points); and a VAS that requires the subject to answer the question, "How healthy do you feel today?" A score of 0 corresponds to the worst health status ever, while 100 equals the best perceived health level. It is possible to combine the scores of the two sections and determine an overall score.

Measurement of well-being described through the Well-Being Index (WHO-5) [23], a self-report tool consisting of 5 statements, to which the subject can respond using a 5-point scale (always=5 points; never=0 points). The total score (from 0 to 25 points) is multiplied by 4 to obtain a score from 0 to 100, where 0 is the worst possible level of well-being and 100 is the best possible level of well-being.