Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04183673 |
| Other study ID # |
2200 CE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 29, 2018 |
| Est. completion date |
February 28, 2019 |
Study information
| Verified date |
March 2022 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective To investigate the effectiveness of the use of the QMD Helios Laser device in
association with standard rehabilitation therapy in reducing inflammatory symptoms in
patients following total knee replacement.
Design Randomized controlled trial. Setting Rehabilitation structure, inpatient Main outcome
measures Pain subscale of the WOMAC and Lequesne's Algo-Functional Index (LIKERT scale), knee
circumference (measured at the middle line of the knee joint space) and knee flexion
/extension range of motion by goniometer.
Description:
As life expectancy increases, more and more people are afflicted with degenerative joint
diseases. Knee osteoarthritis is a pathology typical of old age (over 60 years), but it can
also occur in younger people (aged 40-50 years) and is more prevalent in women (11%) than men
(7%). Total knee replacement surgery is becoming increasingly frequent.In the immediate
post-operative period, the main problems encountered by patients are: inflammation, edema
and, above all, pain. These can strongly influence the restoring of a correct muscle-joint
function and hence the time needed for a return to normal activities of daily living
(ADLs).Post-operative rehabilitation is now a fundamental part of the functional recovery of
patients after knee replacement surgery. Traditional rehabilitation programs are mainly
focused on improving joint mobility, reducing musculotendinous retractions, increasing muscle
strength and establishing a correct gait pattern. Over the years, in addition to the manual
rehabilitative techniques, the use of instrumental methods to stimulate the healing processes
and speed up recovery times has become a frequent practice, especially for the management of
post-operative pain and inflammation. One of these methods is laser therapy, which consists
of light radiation composed of a beam of photons with specific physical characteristics that
interacts with living tissue to produce an anti-inflammatory, analgesic and biostimulation
effect. Another form of instrumental therapy used in rehabilitation for the management of
pain/edema resulting from an inflammatory process is the application of cold (cryotherapy) or
heat (thermotherapy) or both together in combination (contrast therapy). Cryotherapy is a
type of physical therapy that produces temporary anesthesia of the part undergoing
treatment.Thermotherapy consists of the application of heat to stimulate a biological process
inducing the release of chemotactic substances and growth factors, which have a powerful
regenerative and reparative action. An innovative device that combines the therapeutic
advantages of these different forms of physical therapy is QMD Helios (Hakomed, Egna, BZ,
Italy), designed to provide cryo-thermal and laser treatment. The device is equipped with a
high-power diode laser. This therapeutic laser can work at 3 different wavelengths (808
nm,1064 nm, 1120 nm). The wavelengths are each individually controlled and can be delivered
in various modes: continuous wave, pulsed mode, super pulse, and Harmonic pulsation (laser
wave emission with a variable frequency - determined by means of a scan performed by the
device - suited to the tissue to be treated). This innovative triple-wavelength emission
represents the most versatile solution when one wishes to obtain different therapeutic
effects at the same time. In addition to the use of laser, the device allows the application
of cryo-thermal therapy, simultaneously or separately. Simultaneous administration promotes
thermal shock, a basic principle of contrast therapy characterized by a marked variation of
temperature (30-40 degrees) within a short space of time (30-60 seconds) inducing
vasodilation through the heat and vasoconstriction through the cold. Thermal shock is
effective in the early stages of rehabilitation for a rapid resolution of pain and
swelling.Although in recent years instrumental therapy has come to play a very important role
in rehabilitation medicine in the management of pain/inflammation in the acute patient, there
is lack of reported evidence in the literature on the use of laser therapy in patients after
knee replacement surgery. The aim of this study is to evaluate the effectiveness of the use
of the QMD Helios laser device in association with standard rehabilitation therapy in
reducing edema and pain symptoms in patients following total knee replacement.
