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Cervical PainDZeroNCT07274293

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

A study testing DZero in people with Cervical Pain and Lumbar Pain, run by noiVita Srls at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Cervical Pain, Lumbar Pain, Muscular
What is being tested?
DZero
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
6 May 2025to 13 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • DAIRI, Alessandria, 15121

    Alessandria

Other trials in Italy

About this study

Official title: 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.

Being tested
DZero
Medical subject headings
Neck Pain, Low Back Pain, Chronic Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DZeroDevice

    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.

Study groups in NCT07274293
Study groupRoleWhat they receive
DZeroExperimentalThe 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.
Receives: Device: DZero

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measuring quality of life

    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.

    Measured: - T0: baseline - T1: after 7 days - T2: after 30 days

Secondary outcomes (4)

  1. Measuring the patient's state of well-being

    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.

    Measured: - T0: baseline - T1: after 7 days - T2: after 30 days

  2. Perceived comfort when wearing DZero

    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.

    Measured: - T0: baseline - T1: after 7 days - T2: after 30 days

  3. Measurement of pain perception and its sensory dimensions

    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

    Measured: -T0: baseline - T1: after 7 days; - T2: after 30 days

  4. Assess your perception of fatigue during normal daily activities

    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.

    Measured: -T0: baseline -T1: after 7 days -T2: after 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2025
  2. Study start6 May 2025
  3. Primary completion12 Jun 2025
  4. Study completion13 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07274293
Sponsor's protocol ID
1115/CE
Other IDs
University of Eastern Piedmont
Acronym
DZero
Status last verified
Oct 2025
First submitted
27 Nov 2025
Last updated
10 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing DZero in people with Cervical Pain and Lumbar Pain, run by noiVita Srls at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring quality of life (time frame: - T0: baseline - T1: after 7 days - T2: after 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07274293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.

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