EVALUATION OF THE TOLERABILITY AND BIOMEDICAL POTENTIAL OF A GARMENT CONTAINING PRINTED CERAMICS IN MUSCULAR PAIN (DZero)

noiVita Srls

Status: Completed

Conditions: Chronic Pain (Back / Neck); Pain Management; Muscular; Cervical Pain; Lumbar Pain

Treatments: Device: DZero

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07274293

1115/CE

University of Eastern Piedmont (Other Identifier)

Details and patient eligibility

About

Today, a new revolution is underway in the textile industry with the introduction of new technologies that add special functions and properties to fabrics. This innovative revolution will see clothing used not only to protect the body from atmospheric changes or for aesthetic purposes, but also to positively influence health. In this sense, nanoparticles play a key and significant role in this technological evolution as they exhibit exceptional surface properties that allow their effect to be multiplied in comparison to bulky additives and traditional materials. With the development of better technology to deliver pure far infrared radiation (FIR), the benefits of its effects have expanded. The main source of energy needed to power FIR emission from clothing comes from the human body, as it has a higher temperature than the surrounding air. Therefore, energy from the human body is transferred to these ceramic particles, which act as "perfect absorbers," maintaining their temperature at a sufficiently high level and emitting FIR back to the body. At the application level, these fabrics have a wide range of uses, depending on the target of FIR therapy, allowing even in specific conditions to level the concentration of lactic acid, a biological marker associated with cardiovascular diseases and toxins. Other potential benefits include an increase in blood oxygen concentration, improved oxygen and nutrient transport to soft tissues, and muscle relaxation. This potentially prevents contractures while improving muscle tone and alleviating muscle soreness and spasms. This type of tissue approach is a more efficient and less invasive way to provide relief in the area affected by pain, so that it can quickly alleviate muscle pain, cramps, and fatigue, and reduce inflammation.

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 18 and 55;
• Presence of neck or lower back pain for at least 3 months;
• Use of paracetamol in the last 3 months;
• Self-sufficient patients, able to carry out normal daily activities even after wearing the shirt;
• Patients who agree to sign the informed consent form.

Exclusion criteria

• Pregnant or breastfeeding patients;
• Presence of chronic malignant diseases;
• Presence of mild/moderate spasticity;
• Use of pharmacological treatments for neuropathic pain (e.g., nicetile, tricyclic antidepressants, opioids, antiepileptics);
• Presence of known severe concomitant brain damage;
• Presence of known concomitant severe brain damage;
• Presence of psychiatric or neurological disorders;
• Presence of tumors or terminal illnesses;
• Alcohol or substance abuse;
• Hypersensitivity to the product;
• Lack of knowledge of the Italian language;
• Participation in other clinical trials in the last 3 months.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 1 patient group

DZero

Experimental group

Description:

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.

Treatment:

Device: DZero