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

Comparison of the effect of intra-articular injection of hypertonic saline and HIALGAN and knee physiotherapy on pain (with Visual analog state(VAS)) and performance (with Knee injury and Osteoarthritis Outcome Score(KOOS)) in knee osteoarthritis patients Implementation of a uncomplicated and low-cost treatment for knee osteoarthritis

Phase 3 clinical trial , with two intervention groups and one control group in parallel, one blind, randomized with blocks 3 or 6 , with 90 sample

The patients who come to the Physical Medicine Clinic of Imam Reza Hospital. Main variables analysis before, 1 month, 3 months and 6 months after treatment The researcher, outcome evaluator, and data analyzer are blinded by assigning code to each patient, depending on the group being treated.

Inclusion criteria: Patients with knee pain and dysfunction who have the American College of Rheumatology criteria and whose illness is subacute or chronic. Patients with secondary arthritis or diseases that affect the joints and muscles are excluded. Patients who have had joint replacement or recent intra-articular injections are excluded from the study.

1.The patient undergoing intra-articular injection of 5 mililiter Hypertonic saline, 5%, at one time. 2. The patient undergoes HYALGAN intra-articular injection three times 3. The patient undergoes knee physiotherapy (IR, TENS, US (Palsed)) in 10 sessions. For all patients, acetaminophen 500 mg tablets are prescribed for use in the event of pain.Strengthening exercises of quadriceps, hip abductor and hip adductor muscle groups , and hamstring stretching exercises, are prescribed.

Pain severity based on VAS score Severity of symptoms of osteoarthritis, severity of pain, severity of daily activities, joint stiffness and quality of life based on KOOS criteria

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.

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.