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IRCT20101228005486N7 IRCT 2020-02-06 Iran University of Medical Sciences Exercise ‎therapy and NMES in knee osteoarthritis Comparative study of the efficacy of three protocols of Neuromuscular Electrical Stimulation (NMES), exercise ‎therapy and NMES combined with exercise therapy on pain, quadriceps muscle thickness, and physical function of patients with knee osteoarthritis: A controlled randomized trial with a three-month follow-up 2020-04-20 anticipated 75 Complete https://irct.ir/trial/43822 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will randomly be assigned to three treatment groups employing a block randomization method with blocks of size three, produced by PASS software, Blinding description: In this study, the assessor is going to be blinded to the study groups. The outcomes will be evaluated pre and post-intervention by a sports medicine assistant who will be blind about the presence of patients within the groups. Furthermore, the sonography of thigh muscles is done by a sports medicine specialist who won't be aware of the patient groups. Similarly, the data obtained from the study are going to be analyzed by a statistician who isn't aware of the patient groups. N/A Primary knee osteoarthritis. Intervention 1: First intervention group: The Patients in Neuromuscular Electrical Stimulation (NMES) will be treated with Interferential Therapy for 12 sessions (three sessions per week) to strengthen their quadriceps muscle. In this study, Pre-Modulated IF two-pole currents will be used by BTL-4825 S Topline combined electrotherapy system . Intervention 2: Second intervention group: The Patients in this group in addition to Neuromuscular Electrical Stimulation (NMES) similar to the first intervention group will also receive the therapeutic exercises program of the control group . Intervention 3: Control group: Exercise protocol for the patients in the control group consisted of five exercises:1.Static contraction of the quadriceps femoris in a supine position - The patient is asked to lie in the supine position and statically contract the thigh muscles. It will be done for each leg in three sets of 10 repetitions and the duration of static contraction is 10 seconds. 2. Straight legs raising (SLR) in a supine position - The patient is asked to lie in the supine position with one knee in flexed position and raise the other leg straightly. It will be done for each leg in three sets of 10 repetitions and keeping SLR with a ten- second hold. 3.Terminal knee extension n a supine position - The patient is asked to lie in the supine position with one pillow under one of the knees; then the patient should try to extend the flexed knee at the terminal range. In the first two weeks, it will be done in three sets of 10 repetitions with a ten- second hold. 4.Static contraction of hip adductors- The patient is asked to lie in the supine position with the knee flexed and one pillow between the thighs. The patient is asked to press the thighs into the pillow.The exercise will be done in three sets of 10 repetitions for the legs in the first two weeks with a 10-second hold. 5.Wall-sit-The patient is asked to lean against the wall and spread his legs as wide as his shoulders. Then bend your knees slowly to 90 degrees flexion and hold this position for 10 seconds. This exercise will be done in three sets of 10. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical standards, The participants have been promised that the information of this research will remain confidential in their written consent form.
public Dr Soheila Masoudi
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan street
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 saba.17302@yahoo.com Iran University of Medical Sciences scientific Dr Azar Moezy
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan street
Tehran Iran (Islamic Republic of) 14455613131 +98 21 6435 2446 moezy.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale Female gender Age between 50-75 years old Knee pain for at least six months and with intensity 3 on the VAS scale in activities such as getting up and downstairs, sitting and squat No history of knee intra-articular injection in the past six months Referral from a specialist No history of acute traumatic injuries approved by the referral physician No history of previous surgery or injury in the knee joints and lower extremities BMI equal or less than 30 Patient's consent to participate in the research Normal mental state 50 years 75 years Female History of neuromuscular disease Bone implants History of new fractures in lower limbs Participating in exercise therapy and physical therapy programs in the recent three months History of chronic disease and generally any disease or conditions that known to affect the investigation Malignant tumors M17 Osteoarthritis of knee Rehabilitation Rehabilitation Rehabilitation First intervention group: The Patients in Neuromuscular Electrical Stimulation (NMES) will be treated with Interferential Therapy for 12 sessions (three sessions per week) to strengthen their quadriceps muscle. In this study, Pre-Modulated IF two-pole currents will be used by BTL-4825 S Topline combined electrotherapy system . Second intervention group: The Patients in this group in addition to Neuromuscular Electrical Stimulation (NMES) similar to the first intervention group will also receive the therapeutic exercises program of the control group . Control group: Exercise protocol for the patients in the control group consisted of five exercises:1.Static contraction of the quadriceps femoris in a supine position - The patient is asked to lie in the supine position and statically contract the thigh muscles. It will be done for each leg in three sets of 10 repetitions and the duration of static contraction is 10 seconds. 2. Straight legs raising (SLR) in a supine position - The patient is asked to lie in the supine position with one knee in flexed position and raise the other leg straightly. It will be done for each leg in three sets of 10 repetitions and keeping SLR with a ten- second hold. 3.Terminal knee extension n a supine position - The patient is asked to lie in the supine position with one pillow under one of the knees; then the patient should try to extend the flexed knee at the terminal range. In the first two weeks, it will be done in three sets of 10 repetitions with a ten- second hold. 4.Static contraction of hip adductors- The patient is asked to lie in the supine position with the knee flexed and one pillow between the thighs. The patient is asked to press the thighs into the pillow.The exercise will be done in three sets of 10 repetitions for the legs in the first two weeks with a 10-second hold. 5.Wall-sit-The patient is asked to lean against the wall and spread his legs as wide as his shoulders. Then bend your knees slowly to 90 degrees flexion and hold this position for 10 seconds. This exercise will be done in three sets of 10. Pain. Timepoint: Pre-intervention and Post-intervention. Method of measurement: VAS pain scale. Active knee range of flexion. Timepoint: Pre-intervention and Post-intervention. Method of measurement: Goniometery. The circumference of the thigh. Timepoint: Pre-intervention and Post-intervention. Method of measurement: With centimeter tape. Muscle strength of knee extensors. Timepoint: Pre-intervention and Post-intervention. Method of measurement: Manual Muscle Testing. Thickness of Vastus Medialis muscle. Timepoint: Pre-intervention and Post-intervention. Method of measurement: Sonography. Functional Activity. Timepoint: Pre -intervention and Post -intervention. Method of measurement: Timed Up & Go Test and Six-Minute Walk Test. Iran University of Medical Sciences Approved 2019-11-17 Ethics Committee of Iran University of Medical Sciences Iran University Of Medical Sciences, next to Milad Tower, Hemat highway Tehran Tehran Iran (Islamic Republic of)