NCT06239805

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 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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
25 days until next milestone

Study Start

First participant enrolled

February 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 20, 2023

Last Update Submit

January 25, 2024

Conditions

Knee Pain Chronic

Keywords

painphysical therapyQMRgonarthrosissynovial fluidmonocytes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Function

    T0 - 0 days

  • Function

    T1 - 1 mounth of treatment

  • Function

    T2 - 1 mounth after the end of treatment

Other Outcomes (3)

  • Kinesiophobia

    T0 - 0 days

  • Kinesiophobia

    T1 - 1 mounth of treatment

  • Kinesiophobia

    T2 - 1 mounth after the end of treatment

Study Arms (3)

Experimental intensive group

EXPERIMENTAL

Experimental: intensive treatment

Device: QMR

Control extensive group

ACTIVE COMPARATOR

extensive treatment

Device: QMR

control sham group

SHAM COMPARATOR

sham group

Device: QMR

Interventions

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.

Control extensive groupExperimental intensive groupcontrol sham group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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:
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Don Orione Foundation

Pescara, PE, 65128, Italy

Location

MeSH Terms

Conditions

PainOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Antonia Patruno, PhD

    University G. d'Annunzio Chieti Pescara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 20, 2023

First Posted

February 2, 2024

Study Start

February 14, 2023

Primary Completion

June 30, 2023

Study Completion

November 30, 2023

Last Updated

February 2, 2024

Record last verified: 2024-01

Locations

IT(1)