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Completed

NCT Number: NCT06239805

Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis

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 .

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Don Orione Foundation

Pescara, PE, 65128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QMR

Device

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.

Primary outcomes

  1. Knee pain

    Time frame: T0 - 0 days

    Visual Analogue Scale (VAS)

  2. Knee pain

    Time frame: T1 - 1 mounth of treatment

    Visual Analogue Scale (VAS)

  3. Knee pain

    Time frame: T2 - 1 mounth after the end of treatment

    Visual Analogue Scale (VAS)

Secondary outcomes

  1. Function

    Time frame: T0 - 0 days

    Knee injury and Osteoarthritis Outcome Score (KOOS-I)

    • Lysholm Knee Scoring Scale
  2. Function

    Time frame: T1 - 1 mounth of treatment

    Knee injury and Osteoarthritis Outcome Score (KOOS-I)

    • Lysholm Knee Scoring Scale
  3. Function

    Time frame: T2 - 1 mounth after the end of treatment

    Knee injury and Osteoarthritis Outcome Score (KOOS-I)

    • Lysholm Knee Scoring Scale

Other outcomes

  1. Kinesiophobia

    Time frame: T0 - 0 days

    Tampa Scale of Kinesiophobia - TSK

  2. Kinesiophobia

    Time frame: T1 - 1 mounth of treatment

    Tampa Scale of Kinesiophobia - TSK

  3. Kinesiophobia

    Time frame: T2 - 1 mounth after the end of treatment

    Tampa Scale of Kinesiophobia - TSK

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Collaborators

  • Andrea Pantalone
  • Mirko Pesce
  • Roberto Buda
  • Teresa Paolucci

Registry information

Official study title

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

Acronym: QMR

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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