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IRCT20180106038229N1 IRCT 2018-11-27 Shiraz University of Medical Sciences Investigation of the Effect of Concomitant Intraarticular and Periarticular Prolotherapy in Comparison to Intraarticular Prolotherapy in Knee Osteoarthritis without effusion Investigation of the Effect of Concomitant Intraarticular and Periarticular Prolotherapy in Comparison to Intraarticular Prolotherapy in Knee Osteoarthritis without effusion on Pain and Functional Limitation. 2018-06-22 anticipated 112 Complete https://irct.ir/trial/28700 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the randomization process, the envelopes containing letters A and B are used so that the letters inside the envelopes are not recognizable from the outside, as well as the manner in which the envelopes are placed randomly in succession and the person present at the time The randomization of content and the ordering of information in envelopes is not known, Blinding description: Participants, assessing the outcome and analyzing the data, do not know which patient is in the treatment group and only the patients are known under the names of groups A and B. 3 Osteoarthritis, effusion, knee, prolotherapy. Intervention 1: In intervention group number 1, intra-articular injection was performed alone in patients with knee osteoarthritis. In this intervention, 3 cc saline solution 5% and 2 cc of lidocaine 2% were used as a prothotelapy technique Intra-articular injection is performed once a week, and in general, 3 injections are performed within 1 week intervals. Before the intervention, standard variables were evaluated by the Persian standard questionnaire and then 2 weeks after the last Injection of different variables is evaluated again by standard Farsi questionnaires. Intervention 2: In the intervention group number 2, intra-articular and peri-articular injection was performed in patients with knee osteoarthritis. In this intervention, 3 cc of 5% saline solution with 2 cc of lidocaine 2% was used as a orolotherapy technique. Intra-articular and peri-articular injections are performed once a week, and in general, three injections are performed within 1 week intervals. Before the intervention, standard variables were evaluated by the fasi standard questionnaire and then 2 The week after the last injection of different variables was again re-examined by standard Farsi questionnaires Is evaluated. No - There is not a plan to make this available Justification or reason for not sharing IPD is En The forced publication law relates to plans for the year 97. Regarding the fact that our plan will be implemented in year 96, it will be editorial according to the editor's request only if the editor of the journal publishes the paper.
public Sharareh Roshanzamir
Shiraz-Zand St.-Shahid Faghihi Hospital, Department of Rehabilitation
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3231 9040 salmani_r@sums.ac.ir Shiraz University of Medical Sciences scientific Reza Soleymani Asl
Department of Rehabilitation, Shahid Faghihi Hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3231 9040 salmani_r@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Completing informed consent Presence of pain and other clinical symptoms of knee osteoarthritis in the last month 45 years 70 years Both 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 M15.9 Generalized osteoarthritis NOS Treatment - Other Treatment - Other In intervention group number 1, intra-articular injection was performed alone in patients with knee osteoarthritis. In this intervention, 3 cc saline solution 5% and 2 cc of lidocaine 2% were used as a prothotelapy technique Intra-articular injection is performed once a week, and in general, 3 injections are performed within 1 week intervals. Before the intervention, standard variables were evaluated by the Persian standard questionnaire and then 2 weeks after the last Injection of different variables is evaluated again by standard Farsi questionnaires. In the intervention group number 2, intra-articular and peri-articular injection was performed in patients with knee osteoarthritis. In this intervention, 3 cc of 5% saline solution with 2 cc of lidocaine 2% was used as a orolotherapy technique. Intra-articular and peri-articular injections are performed once a week, and in general, three injections are performed within 1 week intervals. Before the intervention, standard variables were evaluated by the fasi standard questionnaire and then 2 The week after the last injection of different variables was again re-examined by standard Farsi questionnaires Is evaluated. Individuals with knee joint osteoarthritis without effusion accopmpanied by pain. Timepoint: In both groups before treatment and 2 weeks after the last injection. Method of measurement: The standard questionnaire of VAS, WOMAC, OKS, which is one of the most commonly used outcome measures in the treatment of knee osteoarthritis, was completed. VAS For pain levels, WOMAC is used to check the pain in everyday activities. OKS is also used to assess the amount of pain and the ability to perform various activities. Individuals with knee joint osteoarthritis without effusion accopmpanied by limitation of motion of knee joint. Timepoint: In both groups before treatment and 2 weeks after the last injection. Method of measurement: The standard questionnaire of VAS, WOMAC, OKS, which is one of the most commonly used outcome measures in the treatment of knee osteoarthritis, was completed. VAS For pain levels, WOMAC is used to check the pain in everyday activities. OKS is also used to assess the amount of pain and the ability to perform various activities. Individuals with knee joint osteoarthritis without effusion accopmpanied by knee joint stiffness. Timepoint: In both groups before treatment and 2 weeks after the last injection. Method of measurement: The standard questionnaire of VAS, WOMAC, OKS, which is one of the most commonly used outcome measures in the treatment of knee osteoarthritis, was completed. VAS For pain levels, WOMAC is used to check the pain in everyday activities. OKS is also used to assess the amount of pain and the ability to perform various activities. Shiraz University of Medical Sciences Approved 2018-05-18 Ethics committee of Shiraz University of Medical Sciences Central Building of Shiraz University of Medical Sciences, opposite Palestine Street, Zand Ave., Shiraz Shiraz Fars Iran (Islamic Republic of)