Clinical trial NCT06239805: Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis
Official title: "Effectiveness of Molecular Quantum Resonance (QMR) in the Rehabiltative Treatment of Gonarthrosis"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Pain Chronic
Keywords: pain
physical therapy
QMR
gonarthrosis
synovial fluid
monocytes
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: Teresa Paolucci
name: Mirko Pesce
name: Roberto Buda
name: Andrea Pantalone
First posted: 2024-02-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 .

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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

Primary outcomes:
measure: Knee pain
timeFrame: T0 - 0 days
measure: Knee pain
timeFrame: T1 - 1 mounth of treatment
measure: Knee pain
timeFrame: T2 - 1 mounth after the end of treatment
Secondary outcomes:
measure: Function
timeFrame: T0 - 0 days
measure: Function
timeFrame: T1 - 1 mounth of treatment
measure: Function
timeFrame: T2 - 1 mounth after the end of treatment
Other outcomes:
measure: Kinesiophobia
timeFrame: T0 - 0 days
measure: Kinesiophobia
timeFrame: T1 - 1 mounth of treatment
measure: Kinesiophobia
timeFrame: T2 - 1 mounth after the end of treatment
Locations:
city: Pescara
country: Italy
facility: Don Orione Foundation
state: PE
Study officials:
affiliation: University G. d'Annunzio Chieti Pescara
name: Antonia Patruno, PhD
role: PRINCIPAL_INVESTIGATOR
References: