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IRCT20171017036837N1 IRCT 2018-09-18 Vice Chancellery of Research and Technology The effect of continues and every another day physical therapy on pain and function in subjects with knee osteoarthritis. Evaluation of the effect of continues and intermittent physical therapy on amount of pain and function in subjects with moderate knee osteoarthritis (pilot randomized clinical trial) 2018-08-22 anticipated 30 Complete https://irct.ir/trial/32713 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Tools used in randomization (throwing coin), Blinding description: Treatments are done by the researcher and evaluations are done by another assessor. The assessor doesn't know about patients grouping.The patients don't know about their group and other groups. since the treatment component was exactly the same in both groups except the frequency of sessions. the participants knew that they will receive standard physical therapy to determine its effect in Iranian subjects. Both groups truly receive standard intervention. N/A Osteoarthritis. Intervention 1: Intervention group: 3 times a week, for 10 sessions every another day will be done. Conventional physiotherapy treatment includes these: 1. Transcutaneous electrical nerve stimulation(TENS): 10HZ, 250 microsecond, 20 minutes, four electrodes medial and lateral to the superior and inferior poles of the patella 2. Hot moist pack for 20 minute 3. Ultrasound: 1 MHz, 2 Watt, 5 minutes, continuous(1-2 minute per 10 cm2) with circular motion covering medial, lateral and anterior aspects of the target knee joint. 4. Quadriceps setting 5. VMO setting. Intervention 2: Control group: 6 times a week, for 10 sessions every day will be done. Conventional physiotherapy treatment includes these: 1. Transcutaneous electrical nerve stimulation(TENS): 10HZ, 250 microsecond, 20 minutes, four electrodes medial and lateral to the superior and inferior poles of the patella 2. Hot moist pack for 20 minute 3. Ultrasound: 1 MHz, 2 Watt, 5 minutes, continuous(1-2 minute per 10 cm2) with circular motion covering medial, lateral and anterior aspects of the target knee joint. 4. Quadriceps setting 5. VMO setting. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Sayed Mohsen Mirbod
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3669 3089 mirbod@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Sayed Mohsen Mirbod
Hezar Jerib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3669 3089 mirbod@rehab.mui.ac.i Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with primary knee osteoarthritis Having criteria of knee osteoarthritis according to American college of rheumatology Patients with grade 2 or 3 Kellgren-lawrence scale of moderate knee osteoarthritis Age more than 40 years Not being in the acute phase of the disease Able to write and read Men and women with moderate knee osteoarthritis Body mass index less than 35 40 years no limit Both Systemic rheumatoid arthritis Secondary knee osteoarthritis Active knee synovitis Severe knee trauma Surgery intervention on knee during 1 year ago Intra-articular injection of corticosteroids or hyaluronic acid for at least the last 6 months Performing a physiotherapy treatment in the last 3 months Taking of Non steroidal anti-inflammatory drug from a week before entering the study Musculoskeletal disorders in lower extrimities Disorders in lumbopelvic and hip region Bilateral involvement of knees which one of them is grade 4 Kellgren-lawrence scale M17.9 Osteoarthritis of knee, unspecified Rehabilitation Rehabilitation Intervention group: 3 times a week, for 10 sessions every another day will be done. Conventional physiotherapy treatment includes these: 1. Transcutaneous electrical nerve stimulation(TENS): 10HZ, 250 microsecond, 20 minutes, four electrodes medial and lateral to the superior and inferior poles of the patella 2. Hot moist pack for 20 minute 3. Ultrasound: 1 MHz, 2 Watt, 5 minutes, continuous(1-2 minute per 10 cm2) with circular motion covering medial, lateral and anterior aspects of the target knee joint. 4. Quadriceps setting 5. VMO setting Control group: 6 times a week, for 10 sessions every day will be done. Conventional physiotherapy treatment includes these: 1. Transcutaneous electrical nerve stimulation(TENS): 10HZ, 250 microsecond, 20 minutes, four electrodes medial and lateral to the superior and inferior poles of the patella 2. Hot moist pack for 20 minute 3. Ultrasound: 1 MHz, 2 Watt, 5 minutes, continuous(1-2 minute per 10 cm2) with circular motion covering medial, lateral and anterior aspects of the target knee joint. 4. Quadriceps setting 5. VMO setting Pain. Timepoint: One day before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Visual Analogue Scale. Function. Timepoint: One day before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Get up and go test. Pain. Timepoint: One day before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Knee injury and osteoarthritis outcome score. Pain. Timepoint: One day before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Intermittent and constant osteoarthritis pain. Function. Timepoint: One day before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Six minute walk test. Function. Timepoint: One day before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Knee injury and osteoarthritis outcome score. Vice Chancellery of Research and Technology Approved 2017-09-11 Ethics committee of Isfahan University of Medical Sciences. Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street Isfahan Isfehan Iran (Islamic Republic of)