Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis (QMR)

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

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 .

Study Overview

• Status: Completed
• Conditions: Knee Pain Chronic
• Intervention / Treatment: Device: QMR

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • PE
    • Pescara, PE, Italy, 65128
      • Don Orione Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental intensive group; Experimental: intensive treatment	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.
Active Comparator: Control extensive group; extensive treatment	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.
Sham Comparator: control sham group; sham group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee pain	Visual Analogue Scale (VAS)	T0 - 0 days
Knee pain	Visual Analogue Scale (VAS)	T1 - 1 mounth of treatment
Knee pain	Visual Analogue Scale (VAS)	T2 - 1 mounth after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function	Knee injury and Osteoarthritis Outcome Score (KOOS-I) - Lysholm Knee Scoring Scale	T0 - 0 days
Function	Knee injury and Osteoarthritis Outcome Score (KOOS-I) - Lysholm Knee Scoring Scale	T1 - 1 mounth of treatment
Function	Knee injury and Osteoarthritis Outcome Score (KOOS-I) - Lysholm Knee Scoring Scale	T2 - 1 mounth after the end of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia	Tampa Scale of Kinesiophobia - TSK	T0 - 0 days
Kinesiophobia	Tampa Scale of Kinesiophobia - TSK	T1 - 1 mounth of treatment
Kinesiophobia	Tampa Scale of Kinesiophobia - TSK	T2 - 1 mounth after the end of treatment

Collaborators and Investigators

• Sponsor: G. d'Annunzio University
• Collaborators: Teresa Paolucci; Mirko Pesce; Roberto Buda; Andrea Pantalone
• Investigators: Principal Investigator: Antonia Patruno, PhD, University G. d'Annunzio Chieti Pescara

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: January 20, 2023
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Estimated): February 2, 2024

Study Record Updates

• Last Update Posted (Estimated): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: pain; physical therapy; monocytes; gonarthrosis; synovial fluid; QMR
• Other Study ID Numbers: Ud'A Chieti-Pescara

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No