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Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery

Primary Purpose

Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Laser therapy-cryo thermal therapy
Usual care
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthropathy focused on measuring Laser Therapy, Cryotherapy, Thermotherapy, Rehabilitation, knee replacement

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • good general physical conditions
  • first total knee replacement

Exclusion Criteria:

  • diabetic neuropathy
  • renal or hearth disease
  • allergic reactions
  • Reynaud's disease
  • lupus
  • rheumatoids arthritis
  • peripheral vascular disease

Sites / Locations

  • ICS Maugeri, Montescano Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Laser-cryo-usual care

usual care

Arm Description

Sessions 5 days a week for 3 weeks. Each session includes laser therapy+ cryo-thermal followed by standard rehabilitation program

Sessions 5 days a week for 3 weeks. Each session includes only standard rehabilitation program

Outcomes

Primary Outcome Measures

Change in Womac Pain subscale
Pain subscale of the Western Ontario and McMaster Universities Activity Index (scored on a five point (0-4) LIKERT scale)
Change in knee circumference
Knee circumference measured at the middle line of the knee joint space
Change in Lequesne's algo Functional Index
Lequesne's algo Functional Index (scored on a five point (0-4) LIKERT scale)

Secondary Outcome Measures

Full Information

First Posted
November 19, 2019
Last Updated
March 31, 2022
Sponsor
Istituti Clinici Scientifici Maugeri SpA
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1. Study Identification

Unique Protocol Identification Number
NCT04183673
Brief Title
Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery
Official Title
Efficacy of Laser + Cryo-thermal Therapy in Rehabilitation Following Total Knee Replacement Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy
Keywords
Laser Therapy, Cryotherapy, Thermotherapy, Rehabilitation, knee replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser-cryo-usual care
Arm Type
Experimental
Arm Description
Sessions 5 days a week for 3 weeks. Each session includes laser therapy+ cryo-thermal followed by standard rehabilitation program
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
Sessions 5 days a week for 3 weeks. Each session includes only standard rehabilitation program
Intervention Type
Procedure
Intervention Name(s)
Laser therapy-cryo thermal therapy
Intervention Description
5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
5 days per week, 3 weeks, sessions of usual rehabilitation
Primary Outcome Measure Information:
Title
Change in Womac Pain subscale
Description
Pain subscale of the Western Ontario and McMaster Universities Activity Index (scored on a five point (0-4) LIKERT scale)
Time Frame
Before treatment (admission) and after treatment (3 weeks after admission)
Title
Change in knee circumference
Description
Knee circumference measured at the middle line of the knee joint space
Time Frame
Before treatment (admission) and after treatment (3 weeks after admission)
Title
Change in Lequesne's algo Functional Index
Description
Lequesne's algo Functional Index (scored on a five point (0-4) LIKERT scale)
Time Frame
Before treatment (admission) and after treatment (3 weeks after admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: good general physical conditions first total knee replacement Exclusion Criteria: diabetic neuropathy renal or hearth disease allergic reactions Reynaud's disease lupus rheumatoids arthritis peripheral vascular disease
Facility Information:
Facility Name
ICS Maugeri, Montescano Rehabilitation Center
City
Montescano
State/Province
Pavia
ZIP/Postal Code
27040
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser + Cryo-thermal Therapy Following Total Knee Replacement Surgery

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