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IRCT20230603058371N1 IRCT 2023-06-07 Tarbiat Modares University Evaluation of Mechanical Traction and Simultaneous High Intensity Laser Irradiation Effects on Pain, Lower Extremity Muscles Activity, and Functional Balance in People with Knee Osteoarthritis Evaluation of Mechanical Traction and Simultaneous High Intensity Laser Irradiation Effects on Pain, Lower Extremity Muscles Activity, and Functional Balance in People with Knee Osteoarthritis 2023-07-06 anticipated 28 Complete https://irct.ir/trial/70470 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation list will be created by a person who is not involved in the evaluation and treatment using Excel 2016 software in such a way that in a two-column table, the right column contains the number of all participants in the order of entry and the left column contains the random letters A (high intensity laser group) and B (high intensity laser and mechanical traction group) which determines the order of random placement of patients in one of the two intervention groups. Concealment of random allocation will be based on opaque, thick, sealed envelopes numbered consecutively. The numbered envelopes with consecutive numbers according to the order of subjects entering the study, determine which of the treatment groups each patient will be placed in, Blinding description: The outcome assessor and the therapist are two different people, and the assessor is not aware of the placement of the patients in the treatment groups. N/A Knee osteoarthritis. Intervention 1: Intervention group: Group 1:The first group is treated with high intensity laser. High intensity laser is applied using the American K LASER device with the following parameters: Wavelengths of 660, 800, 906 and 970 nm, variable maximum power up to 20 watts and average power of 9 watts, 2277 joules of total energy, during 11 phases of 23 seconds (the first and last phase are continuous wave and the other phases are pulse), frequency of the device (10-20000 Hz) and the total duration of the treatment is 4 minutes and 13 seconds. continuous circular movements of the probe on the anterior, medial and external surface of the knee joint line between the epicondyles of the femur and tibia (2000 J) and around the patella (277 J) will be applied. Patients will receive 10 treatment sessions in two weeks. Intervention 2: Intervention group: For group 2, at the same time as applying a high intensity laser with the same parameters as group 1, the continuous traction force is applied equal to 10% of the patient's body weight for 20 minutes through an adjustable weight cuff around the patient's distal leg in a sitting position with the knee in 90 degree flexion. Patients will receive 10 treatment sessions in two weeks. 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 There is no further information
public Pardis Norouzi
Jalal Al Ahmad Ave
Tehran Iran (Islamic Republic of) 14115111 +98 21 82880 pardis.norouzi.pt@gmail.com Tarbiat Modares University scientific Roya Ravanbod
Jalal Al Ahmad Ave
Tehran Iran (Islamic Republic of) 14115111 +98 21 82880 ravanbod@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) People who are symptomatically and radiologically suffering from grade 3 tibiofemoral osteoarthritis based on the Kellgren-Lawrence radiological grading scale and meet the criteria of the American College of Rheumatology Moderate pain range (score 45-74 on the 100 mm VAS scale) Body mass index 25≤BMI<30 Lower limb muscle strength equal to or greater than grade 4 based on Kendall and Daniel 45 years 75 years Both Other rheumatological conditions, recent fracture around the knee, lower limb deformity, osteoporosis, bone tumors Varus knee deformity more than 5 degrees, valgus more than 15 degrees History of cancer Presence of bone implant People with a history of surgery on the knee joint Infection Open wounds or skin disease around the knee joint Injections or physiotherapy on the knee in the last three months, using steroidal or non-steroidal anti-inflammatory drugs in the last 15 days Other causes of pain in the lower limbs (such as polyneuropathy, restless leg syndrome, fibromyalgia, hip joint pathology, spine root compression, central nervous system diseases), mental disorders M17 Osteoarthritis of knee Treatment - Devices Treatment - Devices Intervention group: Group 1:The first group is treated with high intensity laser. High intensity laser is applied using the American K LASER device with the following parameters: Wavelengths of 660, 800, 906 and 970 nm, variable maximum power up to 20 watts and average power of 9 watts, 2277 joules of total energy, during 11 phases of 23 seconds (the first and last phase are continuous wave and the other phases are pulse), frequency of the device (10-20000 Hz) and the total duration of the treatment is 4 minutes and 13 seconds. continuous circular movements of the probe on the anterior, medial and external surface of the knee joint line between the epicondyles of the femur and tibia (2000 J) and around the patella (277 J) will be applied. Patients will receive 10 treatment sessions in two weeks. Intervention group: For group 2, at the same time as applying a high intensity laser with the same parameters as group 1, the continuous traction force is applied equal to 10% of the patient's body weight for 20 minutes through an adjustable weight cuff around the patient's distal leg in a sitting position with the knee in 90 degree flexion. Patients will receive 10 treatment sessions in two weeks. Pain. Timepoint: Before treatment, 48 hours after 10 treatment sessions. Method of measurement: 100 millimeter visual analog scale. Knee function. Timepoint: Before treatment, 48 hours after 10 treatment sessions. Method of measurement: WOMAC questionnaire. The electrical activity of lower extremity muscles includes: Mean root mean square, Median root mean square, Median frequency, Co-contraction index. Timepoint: Before treatment, 48 hours after 10 treatment sessions. Method of measurement: Surface Electromyography signal analysis. Functional balance index include: Center of pressure sway velocity, Rising index, Weight transfer time, Mean absolute error, Standard deviation of absolute error, Root mean square error, Area, Normalized error. Timepoint: Before treatment, 48 hours after 10 treatment sessions. Method of measurement: Kistler MARS device data analysis. Tarbiat Modares University Approved 2023-05-29 Ethics Committee of Tarbiat Modares Faculty of Medical Sciences Jalal Al Ahmad Ave Tehran Tehran Iran (Islamic Republic of)