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IRCT201701025486N5 IRCT 2017-06-19 Vice chancellor for research, Iran University of Medical Sciences The Effect of High Power Laser Therapy on Knee Osteoarthritis . High Power Laser Therapy & Knee Osteoarthritis The Effect of High Power Laser Therapy on Pain and Physical Performance of Patient with Knee Osteoarthritis in comparison with conventional physical therapy. 2016-09-22 anticipated 62 Complete https://irct.ir/trial/5891 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization: Random allocation of the subjects was done by using a random number table and block random sampling; A: HPLT & B: CT (a block size of 4). Block 1: AABB Block 2: ABAB Block 3: BBAA Block 4: BABA Block 5: ABBA Block 6: BAAB In this study the patient, the therapist, as well as the assessor will be blinded to the study groups.The exact type of physical modalities will not be inserted in the consent form so the patient will be blind to treatment. In this study, the patients in HPLT group will be treated on even days and the other group patients will receive their treatment on odd days, to be unaware of treatment programs. The exact type of physical modalities will not be written in the consent form so the patients of each group will be blind to treatment. It should be noted that the exercise therapy protocol will be individually trained to the patient in the first day and an exercise therapy pamphlet with necessary pictures and explanations will be given to the patient to do exercises at home. In addition to the therapists who are responsible for doing therapeutic interventions are different in even and odd days, thus they will be blind to the intervention of the groups. Also, the assessor, a sports medicine assistant, who will evaluate the outcomes pre and post intervention in sports medicine clinic , will be blind to the patients in groups. 2-3 Primary knee osteoarthritis. Intervention 1: Intervention 1 (for HPLT group): The patients will be treated by high-power laser through PYSIOMED system (Belgium ) while the patient lying supine with the knee at 30 ° flexion three times a week for 10 sessions. The applicator (size:6 cm) will be placed vertically in contact with the joint and the knee in longitudinal and perpendicular direction will be scanned and irradiated with HPLT for 8 minutes with a power of 5 watts, duty cycle of 70%, frequency of 30 Hz and energy density 60 joules per square centimeter. Intervention 2: Intervention 2( for the control group): The patients will be treated by Combined BTL-4825 S Topline including High-frequency TENS( Duration: 50 microseconds, pulse rate :100 Hz with a maximum intensity tolerable for the patient , two electrodes on either side of the knee ,the treatment time : 20 minutes ) and Ultrasound (frequency: 1 MHz, mode: Continuous, probe size: 5 cm, treatment time: 8 minutes in the medial and lateral parts of knee in the supine position and with acoustic gel.) three times a week for 10 sessions. Intervention 3: Intervention 3- Common protocol for both groups: Exercise therapy: Also, both groups receive the same, standardized exercise therapy for knee osteoarthritis as follows: 1. Warm-up exercises: slow walking for 5 minutes, hamstring stretch and calf stretch. 2. Major exercises for knee osteoarthritis: SLR (Straight Leg Raise), quadriceps setting, pillow squeeze, heel raise, one leg balance, step ups, quadriceps strengthening exercise. Medication: In order to unify the participants’ medications, all patients will be asked to stop taking their medications one week before the beginning the study and Acetaminophen will prescribe for them at a dose of two grams per day.
public Dr Azar Moezy
Sports Medicine Clinic, Hazrat Rasool Akram Hospital- Sattarkhan Ave, Niayesh St,
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 azarmoezy@yahoo.com Iran University of Medical Sciences scientific Dr Azar Moezy
Sports Medicine Department, Hazrat Rasool Akram Hospital- Sattarkhan Ave, Niayesh St,
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 azarmoezy@yahoo.com Iran University of Medical Sciences. Iran (Islamic Republic of) Inclusion criteria: primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale; age between 50-75; suffering from knee pain for at least six months and with intensity 3 on the VAS scale in activities such as going up and down stairs, sitting and squat; no history of knee intra-articular injection in the past six months; no history of acute traumatic injuries; no history of previous surgery or injury in the knee joints and lower extremities; having a referral from a doctor; BMI equal to or less than 30; patient's consent to participate in the research; lack of neuromuscular disease; normal mental state; absence of bone implants; no history of new fractures; lack of cancerous tumors; no history of chronic disease such as epilepsy, migraine, acute hernia and generally any disease or condition that is known to affect the investigation; participate in sports programs and physical therapy in the recent three months. Exclusion criteria: unwillingness to participate in the study; uncompleted evaluation programs; uncompleted treatment programs; any damage in the knee joint during the study; using any other treatment except for the treatment prescribed in the research project. 50 years 75 years Both M17.0 ,M17 Gonarthrosis [arthrosis of knee] Rehabilitation Rehabilitation Other Intervention 1 (for HPLT group): The patients will be treated by high-power laser through PYSIOMED system (Belgium ) while the patient lying supine with the knee at 30 ° flexion three times a week for 10 sessions. The applicator (size:6 cm) will be placed vertically in contact with the joint and the knee in longitudinal and perpendicular direction will be scanned and irradiated with HPLT for 8 minutes with a power of 5 watts, duty cycle of 70%, frequency of 30 Hz and energy density 60 joules per square centimeter. Intervention 2( for the control group): The patients will be treated by Combined BTL-4825 S Topline including High-frequency TENS( Duration: 50 microseconds, pulse rate :100 Hz with a maximum intensity tolerable for the patient , two electrodes on either side of the knee ,the treatment time : 20 minutes ) and Ultrasound (frequency: 1 MHz, mode: Continuous, probe size: 5 cm, treatment time: 8 minutes in the medial and lateral parts of knee in the supine position and with acoustic gel.) three times a week for 10 sessions. Intervention 3- Common protocol for both groups: Exercise therapy: Also, both groups receive the same, standardized exercise therapy for knee osteoarthritis as follows: 1. Warm-up exercises: slow walking for 5 minutes, hamstring stretch and calf stretch. 2. Major exercises for knee osteoarthritis: SLR (Straight Leg Raise), quadriceps setting, pillow squeeze, heel raise, one leg balance, step ups, quadriceps strengthening exercise. Medication: In order to unify the participants’ medications, all patients will be asked to stop taking their medications one week before the beginning the study and Acetaminophen will prescribe for them at a dose of two grams per day. Pain. Timepoint: pre / post intervention and three months after the intervention. Method of measurement: VAS pain scale. Active knee range of motion. Timepoint: Pre / post intervention and three months after the intervention. Method of measurement: Goniometer. Joint stiffness and functional state. Timepoint: Pre/Post and three months after Intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index. Functional Activity. Timepoint: Pre/Post and three months after Intervention. Method of measurement: Timed Up & Go Test / Six-Minute Walk Test. Vice chancellor for research, Iran University of Medical Sciences Approved 2016-10-18 Ethics committee of Iran University of Medical Sciences Sports Medicine Department, Hazrat Rasool Akram Hospital- Sattarkhan Ave, Niayesh St. Tehran Iran (Islamic Republic of)