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IRCT20190309042989N1 IRCT 2019-04-19 Artesh University of Medical Sciences Comparison of the effect of intra-articular hypertonic saline, intra-articular HIALGAN and physiotherapy in patients with knee arthritis Comparisonof the effectiveness of intra-articular injection of hypertonic saline, intra-articular injection of HIALGAN and knee physiotherapy in pain and function of patients with knee osteoarthritis 2019-05-05 anticipated 90 Complete https://irct.ir/trial/38223 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients with knee osteoarthritis will be recruited from the waiting list of an outpatient Department of Physical Medicine and Rehabilitation at Imam Reza Hospital. The Hospital is a large referral subspecialty center in Tehran affiliated withَ Artesh University of Medical Sciences. We are going to use block randomization with variable block size to provide four samples of equal size and patients are assigned to one of the arms using random blocks (90 samples are included in the study and divided into 3 groups with equal number, the first group :30 samples underwent intra-articular injection of hyper-saline, the second group : 30 samples underwent HYALGAN intra-articular injection and the third group: 30 samples underwent 10-session physiotherapy.). Random numbers will be generated with a computer in an independent statistical office, Blinding description: Due to different treatments and the number of different treatment sessions in each patient group, the patients and physician( was responsible to prescribing and explaining the treatment) was not blinded . The person responsible for evaluating the patients with the pre and post questionnaire (who was the main researcher ) had no information on the treatment process and the patient group, so that the questionnaire was completed before the determination of the treatment method and after beginning of the treatment, every questionnaire depending on treatment method, a code ( 1. 2 or 3 ) is assigned and was in charge for re-evaluation. After completion of the questionnaires, it is available to the data analyst and analyzed using the same allocation code to each data group. 3 Knee osteoarthritis. Intervention 1: First intervention group: Intra-articular injection of 5cc from Hypertonic Saline solution 5%(solution with a concentration of sodium chloride) at one time .Hypersalin brand medication from Shahid Ghazi pharmaceutical company. The method of intra-articular injection of the knee is determined according to the common methods and the amount of access to joint space in the plane radiography (inferomedial or medial, lateral approach). Prescribing 500 mg acetaminophen for use in pain situations and prescribing strengthening exercise for Quadriceps, hip adductors and hip abductors and stretching exercise for calf and hamstring muscles. Intervention 2: Second intervention group: intra-articular injection of 2 cc from HYALGAN (Pre-filled syringe for intra-articular use , contain 20 milligram Hyaluronic acid sodium salt, with 2 miligram volume, From Fidia-Italy pharmaceutical company)inject 3 times with 1 week interval . The method of intra-articular injection of the knee is determined according to the common methods and the amount of access to joint space in the plane radiography (inferomedial or medial, lateral approach) .Prescribing 500 mg acetaminophen for use in pain situations and prescribing strengthening exercise for Quadriceps, hip adductors and hip abductors and stretching exercise for calf and hamstring muscles. Intervention 3: Control group: Knee physiotherapy involves using an infrared device for 20 minutes at a distance of 1 m from the body and perpendicularly, using a transcutaneous electrical nerve stimulation (TENS) device for 20 minutes (with a high TENS protocol that includes a frequency of 100 to 150 Hz , A pulse duration of 150 microseconds and at tolerance level) and the use of an ultrasound device for 3 to 5 minutes (1 MHz frequency, 1.5 Watts per square centimeter and palsed protocol).Prescribing 500 mg acetaminophen for use in pain situations and prescribing strengthening exercise for Quadriceps, hip adductors and hip abductors and stretching exercise for calf and hamstring muscles. 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 Need to make a decision at the University Research Council
public Dr. Ensieh Taftian
Emam Reza Hospital , Etemadzade Ave. ,Fatemi Blvd.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 6653 5399 ensieh.taftian@gmail.com Artesh University of Medical Sciences scientific Dr. Ensieh Taftian
Emam Reza Hospital, Etemadzade Ave., West Fatemi Blvd.
Tehran Iran (Islamic Republic of) 1411718541 +98 21 6653 5399 ensieh.taftian@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) ACR criteria (age more than 50 years old / cryptasion or morning stiffness less than 30 minutes / presence of radiographic evidence / presence of symptoms for more than three months) K-L radiographic criteria : grade 2-4 50 years 80 years Both Patient dissatisfaction Other joint arthritis in the knee joint including rheumatoid arthritis and gout or systemic neuromuscular disorders such as Myasthenia Gravis, Eton-Lambert syndrome and ALS. History of total Knee arthroplasty History of fracture in the knee bones Intra-articular corticosteroid injection over the past 2 weeks, history of hyaluronic acid injection or proletherapy over the past one year Any contraindication for intra-articular injection such as thrombocytopenia , coagulation disorder, joint infections, skin infections at the injection site Dysfunction of the lower extremity due to neurological or internal diseases such as stroke, traumatic brain injury, and diabetic foot disease Severe knee joint effusion BM I> 35 Acute exacerbation of knee pain (less than 1 month) M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Treatment - Devices First intervention group: Intra-articular injection of 5cc from Hypertonic Saline solution 5%(solution with a concentration of sodium chloride) at one time .Hypersalin brand medication from Shahid Ghazi pharmaceutical company. The method of intra-articular injection of the knee is determined according to the common methods and the amount of access to joint space in the plane radiography (inferomedial or medial, lateral approach). Prescribing 500 mg acetaminophen for use in pain situations and prescribing strengthening exercise for Quadriceps, hip adductors and hip abductors and stretching exercise for calf and hamstring muscles. Second intervention group: intra-articular injection of 2 cc from HYALGAN (Pre-filled syringe for intra-articular use , contain 20 milligram Hyaluronic acid sodium salt, with 2 miligram volume, From Fidia-Italy pharmaceutical company)inject 3 times with 1 week interval . The method of intra-articular injection of the knee is determined according to the common methods and the amount of access to joint space in the plane radiography (inferomedial or medial, lateral approach) .Prescribing 500 mg acetaminophen for use in pain situations and prescribing strengthening exercise for Quadriceps, hip adductors and hip abductors and stretching exercise for calf and hamstring muscles. Control group: Knee physiotherapy involves using an infrared device for 20 minutes at a distance of 1 m from the body and perpendicularly, using a transcutaneous electrical nerve stimulation (TENS) device for 20 minutes (with a high TENS protocol that includes a frequency of 100 to 150 Hz , A pulse duration of 150 microseconds and at tolerance level) and the use of an ultrasound device for 3 to 5 minutes (1 MHz frequency, 1.5 Watts per square centimeter and palsed protocol).Prescribing 500 mg acetaminophen for use in pain situations and prescribing strengthening exercise for Quadriceps, hip adductors and hip abductors and stretching exercise for calf and hamstring muscles. Pain intensity based on the Visual Analogue Scale. Timepoint: Measuring pain intensity before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Visual Analogue Scale. Symptoms. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Pain. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Function, daily living. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Function, sports and recreational activities. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Quality of Life. Timepoint: Before the intervention, 1 month, 3 months and 6 months after the end of the intervention. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS). Artesh University of Medical Sciences Approved 2019-04-13 Ethics committee of Artesh University of Medical Sciences Emam Reza Hospital , Etemadzade Ave. , West Fametemi Blvd. Tehran Tehran Iran (Islamic Republic of)