Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06239805
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2023-01-20
Brief Title:
Quantum Molecular Resonance QMR Rehabiltative Treatment of Knee Osteoarthritis
Sponsor:
G dAnnunzio University
Organization:
G dAnnunzio University
Study Overview
Official Title:
Effectiveness of Molecular Quantum Resonance QMR in the Rehabiltative Treatment of Gonarthrosis
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QMR
Brief 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 effectThe 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 srl 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 proanti-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 proanti-inflammatory macrophage phenotype
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None