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临床试验/NCT07274293
NCT07274293已完成不适用

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

noiVita Srls1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年5月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Measuring quality of life

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Measuring quality of life

时间窗: - 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.

次要结局

  • Measuring the patient's state of well-being(- T0: baseline - T1: after 7 days - T2: after 30 days)
  • Perceived comfort when wearing DZero(- T0: baseline - T1: after 7 days - T2: after 30 days)
  • Measurement of pain perception and its sensory dimensions(-T0: baseline - T1: after 7 days; - T2: after 30 days)
  • Assess your perception of fatigue during normal daily activities(-T0: baseline -T1: after 7 days -T2: after 30 days)

研究者

发起方
noiVita Srls
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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