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

November 27, 2025 updated by: noiVita Srls

EVALUATION OF THE TOLERABILITY OF A T-SHIRT CONTAINING PRINTED CERAMICS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Alessandria, Italy
        • DAIRI, Alessandria, 15121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DZero
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.
Device: DZero
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measuring quality of life
Time Frame: - T0: baseline - T1: after 7 days - T2: after 30 days
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.
- T0: baseline - T1: after 7 days - T2: after 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measuring the patient's state of well-being
Time Frame: - T0: baseline - T1: after 7 days - T2: after 30 days
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.
- T0: baseline - T1: after 7 days - T2: after 30 days
Perceived comfort when wearing DZero
Time Frame: - T0: baseline - T1: after 7 days - T2: after 30 days
The thermal comfort perceived by the occupants of the environment will also be described, using the ASHRAE (American Society of Heating, Refrigerating and Air-Conditioning Engineers) scale.This scale is a standardized and internationally recognized tool for assessing the subjective thermal comfort of people in a given environment. It is based on a personal assessment expressed on a 7-point scale (from +3, very hot, to -3, very cold, with 0 indicating neither hot nor cold), ranging from a feeling of extreme cold to a feeling of extreme heat.
- T0: baseline - T1: after 7 days - T2: after 30 days
Measurement of pain perception and its sensory dimensions
Time Frame: -T0: baseline - T1: after 7 days; - T2: after 30 days
Measurement of pain perception and its sensory dimensions, which were quantified and described using the Short Form-McGill Pain Questionnaire (SF-MPQ). The scale consists of 78 words, each of which describes a painful sensation in detail, divided into four main categories: sensory (sections 1-10), affective (sections 11-15), evaluative (section 16), and miscellaneous (sections 17-20). These 20 sections contain between 3 and 6 descriptive words. The subject to whom it is administered must then highlight the words that best describe their pain. Within each section, the words are assigned a score in ascending order of severity, ranging from 0 (no pain) to 3 (severe), and it is possible to choose more than one word per section; the word corresponding to the highest score will be chosen to define the final score. The words with the highest scores for each section will be added together and used to determine the Pain Rating Index (PRI). The questionnaire only gives a score and not
-T0: baseline - T1: after 7 days; - T2: after 30 days
Assess your perception of fatigue during normal daily activities
Time Frame: -T0: baseline -T1: after 7 days -T2: after 30 days
Measurement of perceived fatigue and exertion using the Borg scale CR 10. This tool is used to assess the perceived intensity of physical exercise on a numerical scale ranging from 0 (no exertion) to 10 (maximum exertion perceived in one's life). The assessment of perceived exertion is carried out at the end of a daily activity involving at least 30 minutes of movement .This is to avoid the influence of the most recent exertion. It is essential to educate the subject on how to collect data on perceived exertion, avoiding confusion between perceived exertion and perceived pain.
-T0: baseline -T1: after 7 days -T2: after 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
noiVita Srls

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Eastern Piedmont

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1115/CE
  • University of Eastern Piedmont (Other Identifier: University of Eastern Piedmont)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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