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Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06239805
Acronym
QMR
Enrollment
30
Registered
2024-02-02
Start date
2023-02-14
Completion date
2023-11-30
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Pain Chronic

Keywords

pain, physical therapy, QMR, gonarthrosis, synovial fluid, monocytes

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.

Interventions

DEVICEQMR

A: Treated group (active medical device): intensive protocol B: Treated Group (active medical device): extensive protocol C: Sham/Control group (medical device off) Patients will be treated as follows: A- Treated Group: three sessions a week, for a total of 6 sessions, with one session lasting of 30 minutes. The session involves the application of electrodes (adhesive plates), and Q- glove Touch (frequency/intensity) B- Treated Group: two sessions a week, for a total of 8 sessions, lasting a 20 minute session. The session involves the application of electrodes (adhesive plates), e Q-Touch glove (frequency/intensity) C- Control/Sham group: three sessions a week, for a total of 6 sessions, lasting a 30 minute session. The session involves the application of electrodes (adhesive plates), e Q-Touch glove with device off.

Sponsors

Teresa Paolucci
CollaboratorUNKNOWN
Mirko Pesce
CollaboratorUNKNOWN
Roberto Buda
CollaboratorUNKNOWN
Andrea Pantalone
CollaboratorUNKNOWN
G. d'Annunzio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Knee painT0 - 0 daysVisual Analogue Scale (VAS)

Secondary

MeasureTime frameDescription
FunctionT0 - 0 daysKnee injury and Osteoarthritis Outcome Score (KOOS-I) \- Lysholm Knee Scoring Scale

Other

MeasureTime frameDescription
KinesiophobiaT0 - 0 daysTampa Scale of Kinesiophobia - TSK

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026