跳至主要内容
临床试验/NCT06239805
NCT06239805已完成不适用

"Effectiveness of Molecular Quantum Resonance (QMR) in the Rehabiltative Treatment of Gonarthrosis"

G. d'Annunzio University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Knee pain

研究概览

简要总结

Gonarthrosis (osteoarthritis of the knee (OA) is a chronic-degenerative disease, characterized by progressive joint damage up to disability that affects about 40% of people over 65 years of age. Its typical pathological changes, articular cartilage degradation, synovial inflammation and subchondral bone thickening, are responsible for the pain and disability of patients. It is now known that "biophysical stimulation" techniques represent a non-invasive therapy used in orthopedic practice to enhance the reparative and anabolic activities of the tissues through an anti-inflammatory and chondro-protective effect.The aim of the study will be to evaluate the anti-inflammatory effects and the relative mechanisms of action of the therapeutic interventions of the QMR technology (Molecular Quantum Resonance) in the treatment of gonarthrosis through the use of in vivo and in vitro models. This technology, supplied by Telea Electronic Engineering s.r.l., exploits non-ionizing high-frequency waves in the range between 4 and 64 MHz at low intensity delivered through alternating electric fields. For the in vivo study, a double-blind randomized controlled clinical trial will be conducted. Both male and female subjects, aged between 40 and 80 years, with knee pain both in the acute and chronic phase of gonarthosis, diagnosed on standard radiography, will be enrolled. Patients will be randomized into 2 groups treated with an intensive or extensive protocol, and a third untreated control group. They will be evaluated at T0 (before treatment), at T1 (end of QMR treatment), and at T2 (one month after the end of treatment (follow-up)). All patients will be assessed for pain and functionality, furthermore synovial fluid and blood sampling will be performed, for the quantitative assessment of the inflammatory state considering the levels of the main pro-inflammatory cytokines and the pro/anti-inflammatory macrophage phenotype. In parallel, in order to delineate the molecular and cellular mechanism of action of QMR stimulation in vitro, a monocyte cell model (THP-1 cell line) will be used to evaluate the response of QMR treatment after treatment with known pro-inflammatory stimuli .

详细描述

For the in vivo study, a double-blind randomized controlled clinical trial will be conducted. Both male and female subjects, aged between 40 and 80 years, with knee pain both in the acute and chronic phase of gonarthosis, diagnosed on standard radiography, will be enrolled. Patients will be randomized into 2 groups treated with an intensive or extensive protocol, and a third untreated control group. They will be evaluated at T0 (before treatment), at T1 (end of QMR treatment), and at T2 (one month after the end of treatment (follow-up). All patients will be assessed for pain and functionality, furthermore synovial fluid and blood sampling will be performed, for the quantitative assessment of the inflammatory state considering the levels of the main pro-inflammatory cytokines and the pro/anti-inflammatory macrophage phenotype.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both male and female subjects, aged between 40 and 80 years, with knee pain both in acute and chronic phase due to gonarthosis diagnosed on standard radiography will be enrolled.
  • Diagnosis of gonarthrosis with VAS >3
  • Presence of acute or chronic pain (the sample will be stratified in one phase next)
  • Radiographic picture of gonarthrosis and staging score according to Kellegren-Lawrence classification (I-II-III)

排除标准

  • favism, hemolytic anemia
  • severe hyperthyroidism - Graves' disease;
  • drug treatment with Tapazole;
  • thrombocytopenia less than 50,000 and serious coagulation disorders;
  • severe cardiovascular instability;
  • coagulation defects;
  • alcohol abuse;
  • hemochromatosis;
  • patients being treated with food-nutraceutical supplements;
  • pregnancy and bed rest;
  • psychiatric pathologies;
  • less than three months from previous knee infiltrations
  • septic arthritis and/or febrile states
  • anamnestic contraindications to the instrumental physical therapy in use (tumor pathologies past)
  • Furthermore, the following subjects will be excluded from the study:
  • with rheumatic and autoimmune diseases
  • patients with recent history of trauma and/or knee (ligament) sprain injuries

结局指标

主要结局

Knee pain

时间窗: T2 - 1 mounth after the end of treatment

Visual Analogue Scale (VAS)

次要结局

  • Function(T2 - 1 mounth after the end of treatment)

研究者

发起方
G. d'Annunzio University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonia Patruno

Associate Professor

G. d'Annunzio University

研究点 (2)

Loading locations...

相似试验