Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis
Condition: Knee Pain Chronic
Study type: Interventional

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.
    

Intervention name(s): QMR
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain; physical therapy; QMR; gonarthrosis; synovial fluid; monocytes