Knee Pain ChronicQMRNCT06239805
Quantum Molecular Resonance (QMR) Rehabiltative Treatment of Knee Osteoarthritis
A study testing QMR in people with Knee Pain Chronic, run by G. d'Annunzio University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Pain Chronic
- What is being tested?
- QMR
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "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 .
Read the 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.
- Conditions
- Knee Pain Chronic
- Being tested
- QMR
- Keywords
- pain, physical therapy, QMR, gonarthrosis, synovial fluid, monocytes
- Medical subject headings
- Pain, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QMRDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental intensive group | Experimental | Experimental: intensive treatment Receives: Device: QMR |
| Control extensive group | Active comparator | extensive treatment Receives: Device: QMR |
| control sham group | Sham comparator | sham group Receives: Device: QMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Visual Analogue Scale (VAS)
Measured: T0 - 0 days
Knee pain
Visual Analogue Scale (VAS)
Measured: T1 - 1 mounth of treatment
Knee pain
Visual Analogue Scale (VAS)
Measured: T2 - 1 mounth after the end of treatment
Secondary outcomes (3)
Function
Knee injury and Osteoarthritis Outcome Score (KOOS-I)
- Lysholm Knee Scoring Scale
Measured: T0 - 0 days
Function
Knee injury and Osteoarthritis Outcome Score (KOOS-I)
- Lysholm Knee Scoring Scale
Measured: T1 - 1 mounth of treatment
Function
Knee injury and Osteoarthritis Outcome Score (KOOS-I)
- Lysholm Knee Scoring Scale
Measured: T2 - 1 mounth after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start14 Feb 2023
- Primary completion30 Jun 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Collaborators
- Teresa Paolucci, Mirko Pesce, Roberto Buda, Andrea Pantalone
- Responsible party
- Principal investigator, Antonia Patruno, G. d'Annunzio University
- Investigators
- Antonia Patruno, PhD, Principal investigator, University G. d'Annunzio Chieti Pescara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239805
- Sponsor's protocol ID
- Ud'A Chieti-Pescara
- Acronym
- QMR
- Status last verified
- Jan 2024
- First submitted
- 20 Jan 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Molecular Quantum Resonance (QMR) in the Rehabiltative Treatment of Gonarthrosis"
- ClinicalTrials.gov ID
- NCT06239805
- Acronym / sponsor ID
- QMR / Ud'A Chieti-Pescara
- Conditions
- Knee Pain Chronic
- Keywords
- pain, physical therapy, QMR, gonarthrosis, synovial fluid, monocytes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Collaborators
- Teresa Paolucci, Mirko Pesce, Roberto Buda, Andrea Pantalone
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental intensive group | Experimental | Device: QMRExperimental: intensive treatment |
| Control extensive group | Active comparator | Device: QMRextensive treatment |
| control sham group | Sham comparator | Device: QMRsham group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (17 listed)
- favism, hemolytic anemia
- severe hyperthyroidism - Graves' disease;
- drug treatment with Tapazole;
- thrombocytopenia less than 50,000 and serious coagulation disorders;
- severe cardiovascular instability;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QMRA: 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. | Device | Control extensive group, Experimental intensive group, control sham group |
Primary outcome
Knee pain
Time frame: T0 - 0 days
Visual Analogue Scale (VAS)
Knee pain
Time frame: T1 - 1 mounth of treatment
Visual Analogue Scale (VAS)
Knee pain
Time frame: T2 - 1 mounth after the end of treatment
Visual Analogue Scale (VAS)
3 secondary outcomes
Function
Time frame: T0 - 0 days
Function
Time frame: T1 - 1 mounth of treatment
Function
Time frame: T2 - 1 mounth after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Patruno, PhD principal investigator
University G. d'Annunzio Chieti Pescara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QMR in people with Knee Pain Chronic, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain (time frame: T0 - 0 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.