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IRCT20170131032338N3 IRCT 2018-01-29 Tehran University of medical sciences, Research and Technology Dept. Effect of High power Laser in Knee Osteoarthritis Comparing the short-term Effects of Continues, Pulsed and Super pulsed High power Laser irradiation on Pain and Function in Patient with Knee Osteoarthritis 2018-01-31 anticipated 52 Complete https://irct.ir/trial/25226 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are simply randomized to three experimental groups (Pulsed and Super pulsed High power Laser ) through random number table; received a special code and are treated with own group treatment, Blinding description: treatments are done by the researcher and; evaluations are done by another evaluator; none of them doesn't understand about patients grouping. moreover, analysis of data is done by a statistician who doesn't know about grouping. Also, the patients don't know about their group and other groups. N/A Knee Osteoarthritis. Intervention 1: The first group: 5 treatment sessions with continuous high power laser according to the Knee-arthrosis protocol of the Lumix 3 ultra device produced by Fisioline, Italy on the 8 points of the knee joint during 10 minutes with the total energy dose of 251.2 J accompanied by 3 routine exercise for knee osteoarthritis include: 1- Quadriceps setting, 2- Straight Leg Raising (SLR) and 3- Hamstring muscle stretching exercises. Intervention 2: The second group: 5 treatment sessions with pulsed high power laser according to the Analgesic protocol of the Lumix 3 ultra device produced by Fisioline, Italy on the 8 points of the knee joint during 10 minutes with the total energy dose of 199 J accompanied by 3 routine exercise for knee osteoarthritis include: 1- Quadriceps setting, 2- Straight Leg Raising (SLR) and 3- Hamstring muscle stretching exercises. Intervention 3: The third group: 5 treatment sessions with super-pulsed high power laser according to the Knee-arthrosis protocol of the Lumix 3 ultra device produced by Fisioline, Italy on the 8 points of the knee joint during 10 minutes with the total energy dose of 565 J accompanied by 3 routine exercise for knee osteoarthritis include: 1- Quadriceps setting, 2- Straight Leg Raising (SLR) and 3- Hamstring muscle stretching exercises. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Rahimpour Nadia
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Shiraz Iran (Islamic Republic of) 7144984765 +98 71 3228 6628 n-rahimpour@student.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age ≥ 50 Osteoarthritic knee of grade 2-3 based on radiographic diagnosis in the Kellegren and Lawrence grading of osteoarthritis by orthopedist physician. The minimum score of 25 on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score Knee pain ≥ 4 on the visual analog scale (VAS) 50 years no limit Both History of physiotherapy and/or intra-articular injections during last 6 months. Any history of knee surgery History of fracture in knee History of tearing of tendons, ligaments and menisci in knee joint Central or peripheral neuropathy Romatoid Arthritis Malignancy in knee joint Psychologic problems Metabolic disease such as Diabetes, Thyroid, and Kidney problems Infective disease Ankylosis Sever Synovitis Sever valgus or Varus deformity Incomplete treatment for any reasons Osteoarthritic knee of grade 1,4 based on radiographic diagnosis in the Kellegren and Lawrence grading of osteoarthritis M17 Gonarthrosis [arthrosis of knee] Rehabilitation Rehabilitation Rehabilitation The first group: 5 treatment sessions with continuous high power laser according to the Knee-arthrosis protocol of the Lumix 3 ultra device produced by Fisioline, Italy on the 8 points of the knee joint during 10 minutes with the total energy dose of 251.2 J accompanied by 3 routine exercise for knee osteoarthritis include: 1- Quadriceps setting, 2- Straight Leg Raising (SLR) and 3- Hamstring muscle stretching exercises. The second group: 5 treatment sessions with pulsed high power laser according to the Analgesic protocol of the Lumix 3 ultra device produced by Fisioline, Italy on the 8 points of the knee joint during 10 minutes with the total energy dose of 199 J accompanied by 3 routine exercise for knee osteoarthritis include: 1- Quadriceps setting, 2- Straight Leg Raising (SLR) and 3- Hamstring muscle stretching exercises. The third group: 5 treatment sessions with super-pulsed high power laser according to the Knee-arthrosis protocol of the Lumix 3 ultra device produced by Fisioline, Italy on the 8 points of the knee joint during 10 minutes with the total energy dose of 565 J accompanied by 3 routine exercise for knee osteoarthritis include: 1- Quadriceps setting, 2- Straight Leg Raising (SLR) and 3- Hamstring muscle stretching exercises. Pain Score. Timepoint: Evaluating the pain score before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: (Visual Analog Scale) VAS and (MCQ) (Mc-gill Questionnaire). Knee Function Score. Timepoint: Evaluating the knee function score before the first and immediately after the fifth treatment sessions. Method of measurement: WOMAC Questionnaire. Edema of knee joint, 10 cm above and 10 cm belong that. Timepoint: Evaluating the knee joint edema before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: Measuring tape. Active Knee Extension ROM. Timepoint: Evaluating Active Knee Extension ROM before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: Goniometer. Active Knee Flexion ROM. Timepoint: Evaluating Active Knee Flexion ROM before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: Goniometer. Passive Knee Flexion ROM. Timepoint: Evaluating Passive Knee Flexion ROM before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: Goniometer. Measuring Active Popliteal Angle. Timepoint: Measuring Active Popliteal Angle before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: Goniometer. Measuring Passive Popliteal Angle. Timepoint: Measuring Passive Popliteal Angle before the first session and immediately after the first and the fifth treatment sessions. Method of measurement: Goniometer. Tehran University of medical sciences, Research and Technology Dept. Approved 2017-08-06 Ethics Committee of Tehran University of Medical Sciences Official Building, Medicine Faculty of Tehran University of Medical Sciences, Poorsina Ave., 16 Azar Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)