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Study aim
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Determine the average of the VAS score for the initial visit and before starting the treatment in both groups.
Determine the average VAS score after the last injection and in weeks 2 and 4 in each group.
Comparison of average VAS score in both groups before and after treatment.
Determine the average WOMAC score for joint pain in various routine activities in the initial visit and before starting treatment in both groups.
Determine the average WOMAC score for joint stiffness in the initial visit and before starting treatment in each group.
Determine the average score of WOMAC for the daily functions in the initial visit and before starting treatment in both groups.
Determine the average WOMAC score for joint stiffness after the last injection and in weeks 2 and 4 in both groups.
Determine the average score of WOMAC for the daily functions after the last injection and in weeks 2 and 4 in both groups.
Comparison of the average WOMAC score for joint pain in various routine activities in both groups before and after the last injection and at weeks 2 and 4.
Comparison of average WOMAC score of joint stiffness in both groups before and after the last injection and in weeks 2 and 4.
Comparison of the average WOMAC score of the daily functions in both groups before and after the last injection and at weeks 2 and 4.
Determine the average of the OKS score. Ability to perform various activities in the initial visit and before starting treatment in both groups.
Determine the average of the OKS score. Ability to perform various activities after the last injection and in weeks 2 and 4 in both groups.
Comparison of the average of the OKS score. Ability to perform different activities in both groups before and after the last injection and in weeks 2 and 4.
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Design
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The study population consisted of 112 patients with a history of knee pain due to osteoarthritis that causes pain and fatigue, functional limitation, decrease range of motion , which was detected by plain radiography, were randomly divided into two groups: A and B (56 People in each group). Demographic characteristics of both groups in terms of age, sex, type and joint destruction (on The basis of radiological standards is similar). To randomize the study, a randomized block method is used.
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Settings and conduct
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This is a randomized clinical trial that was conducted on referrals to physicians and rehabilitation clinics of Shiraz University of Medical Sciences - Imam Reza Clinic (AS) and Shahid Chamran and Shahid Rajaee Hospitals.
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Participants/Inclusion and exclusion criteria
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The criteria for entering the study were: completing informed consent; the presence of pain and other clinical symptoms of knee osteoarthritis in the last month; age between 45-70 years old; and the absence of any disease around the relevant joint.
Exclusion criteria: diabetes, rheumatic diseases and collagen and vascular disease, gout and lupus, radiculopathy, nerve injury and neuropathy; Brucella infection; BMI> 42; history of knee replacement on the affected side; bleeding disorder; inability to communicate and complete questionnaires; history of allergy and allergic reaction to used drugs; history of significant liver, kidney and cardiovascular disorders; history of injections inside or around the joint in the last 3 months; pregnant women; people who have cancer; people who are on the go use of anticoagulants.
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Intervention groups
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Treatment in group A includes intra-articular and periarticular injection of 3 ml saline 5% plus 3 ml Lidocaine 2% along with advice on observing the correct way of life and exercising proper knee pain that is help to them. Group B treatment includes intra-articular injection of 3 ml of saline 5% plus 3 ml of lidocaine 2% plus recommendation to Observing the right way of life and doing proper knee pain exercises that are help to them. For each of the two groups, 3 injection steps are performed within 2 weeks.
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Main outcome variables
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More possible improvements in the symptoms of osteoarthritis in patients with intra-articular and periarticular prolotherapy in comparision intra-articular prolotherapy alone, in knee osteoarthritis with effusion.