Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis

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 .

Conditions

• Knee Pain Chronic

Interventions

DEVICE

QMR

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 & Collaborators

• Teresa Paolucci

  collaborator UNKNOWN

• Mirko Pesce

  collaborator UNKNOWN

• Roberto Buda

  collaborator UNKNOWN

• Andrea Pantalone

  collaborator UNKNOWN

• G. d'Annunzio University

  lead OTHER

Principal Investigators

• Antonia Patruno, PhD · University G. d'Annunzio Chieti Pescara

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-14

Primary Completion

2023-06-30

Completion

2023-11-30

Countries

• Italy

Study Locations