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IRCT20140810018754N9 IRCT 2018-11-03 Iran University of Medical Sciences The effects of high intensity laser therapy on knee ostoarthrosis The effects of High Intensity Laser Therapy(HILT) in comparison with Intra Articular Hyaluronic Acid(IAHA) injection on the pain and function of knee ostoarthrosis 2018-09-15 anticipated 75 Complete https://irct.ir/trial/33711 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization Unit of randomization: personal Using the SPSS program, Blinding description: Examiner did not know that each simple present in witch group. N/A Knee ostoarthrosis. Intervention 1: Intervention group 1: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, whom received weekly (more accurately, for times a week) hyaluronic acid injection. The patients are to be undergone physiotherapy simultaneous with their getting the injections. the physiotherapy treatment comprises 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, IR for 15 minutes, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions. Intervention 2: Intervention group 2: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, receiving physiotherapy treatment as well as High Intensity Laser Therapy(HILT) . the laser's treatment protocol in the first three sessions is as follows: duty cycle:50%, frequency: 5000 Hz, Power density2.04 W, Energy density 10 J/cm2, treatment duration: 3 minute, the approximate treatment area : 100cm2 round the knee and the total apleid energy is 1000 J. However, the laser's treatment protocol in the next seven sessions is as follows:Power density 4.09 W, Energy density 50 J/cm2, treatment duration: 7 minute, the approximate treatment area : 100cm2 round the knee, the total apleid energy is 5000 J. and the laser's wavelength is 980 nm. The physiography treatment of this group comprises, as does the invention group 1, 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, IR for 15 minutes, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions. Intervention 3: Control group: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, receiving physiotherapy treatment as well as placebo High Intensity Laser Therapy (HILT), that is to say, the treatment is performed in a similar manner as to intervention group 2 ,though the laser fluency is lacking. As was the case for intervention group 1 and 2, the physiography treatment of this group comprises 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions. Yes - There is a plan to make this available What will be shared: All data or results of the present study will be presented in an article or some articles that will be published after completing the study. When: After completing the present study and publishing the resulting article or articles. To whom: All researchers in the field of the present study. Conditions: With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences. Where to obtain: The corresponding author of the article or articles derived from this study. How to obtain: Written request from the author responsible for the present review after the publication of the resulting article or articles. Comments:
public Javad Sarrafzadeh
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences scientific Javad Sarrafzadeh
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Madar squ., Mirdamad street.
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 8051 sarrafzadeh.j@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Grade 1 or 2 knee osteoarthritis according to the Kellgren-Lawrence classification had a knee painā‰„4 on the visual analog scale (VAS) do not injection corticostroid or hyaluronic acid in last six mount the gain 25 number in minimum condition from the WOMAC scale BMI < 30 45 years 75 years Both existence RA, malignancy, knee surgery, fracture, menisqe or ligament tearing, genu varum or valgum above 20 degree, referal pain from hip or lumbar region doing physiotherapy in last six mount M17 Osteoarthritis of knee Treatment - Other Treatment - Other Treatment - Other Intervention group 1: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, whom received weekly (more accurately, for times a week) hyaluronic acid injection. The patients are to be undergone physiotherapy simultaneous with their getting the injections. the physiotherapy treatment comprises 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, IR for 15 minutes, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions. Intervention group 2: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, receiving physiotherapy treatment as well as High Intensity Laser Therapy(HILT) . the laser's treatment protocol in the first three sessions is as follows: duty cycle:50%, frequency: 5000 Hz, Power density2.04 W, Energy density 10 J/cm2, treatment duration: 3 minute, the approximate treatment area : 100cm2 round the knee and the total apleid energy is 1000 J. However, the laser's treatment protocol in the next seven sessions is as follows:Power density 4.09 W, Energy density 50 J/cm2, treatment duration: 7 minute, the approximate treatment area : 100cm2 round the knee, the total apleid energy is 5000 J. and the laser's wavelength is 980 nm. The physiography treatment of this group comprises, as does the invention group 1, 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, IR for 15 minutes, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions. Control group: This group constitutes patients with knee arthrosis, on the basis of Kellgren- Lawrence classification grade 1 or 2, receiving physiotherapy treatment as well as placebo High Intensity Laser Therapy (HILT), that is to say, the treatment is performed in a similar manner as to intervention group 2 ,though the laser fluency is lacking. As was the case for intervention group 1 and 2, the physiography treatment of this group comprises 20-minute IF current , US applied continuous for 5 minutes with 1 W/cm2 intensity, as well as the exercise training. The physiotherapy treatment must be performed weekly (triple a week) for 10 sessions. Intensity of pain. Timepoint: before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session. Method of measurement: Visual analog scale (VAS). Function and quality of life. Timepoint: before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session. Method of measurement: persian WOMAC scal. Rang of motion of knee FLX and EXT. Timepoint: before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session. Method of measurement: KROM device (degree). Amount of knee odema. Timepoint: before starting the first treatment session, after the end of treatment session and one mount after the last of treatment session. Method of measurement: tape measure according in CM. Iran University of Medical Sciences Approved 2018-08-25 Ethics committee of Iran University of Medical Sciences 5th floor, Iran University of Medical Sciences, Hemmat highway, between Sheikh Fazlollah Nuri and Chamran highways. tehran Tehran Iran (Islamic Republic of)