Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery
Condition: Knee Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Laser therapy-cryo thermal therapy; Usual care
Intervention type(s): Procedure; Procedure
Intervention description(s): 5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation; 5 days per week, 3 weeks, sessions of usual rehabilitation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laser Therapy; Cryotherapy; Thermotherapy; Rehabilitation; knee replacement