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IRCT20190912044756N1 IRCT 2020-08-24 Shiraz University of Medical Sciences Evaluation of efficacy of intra articular injection of mannitol in patient with knee osteoarthritis Evaluation of efficacy of intra articular injection of mannitol versus hypertonic dextrose prolotherapy on decreasing pain and improvement of functions in patients with knee osteoarthritis 2020-05-20 anticipated 60 Complete https://irct.ir/trial/47109 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Complete randomize block design with SSPP software is used for randomization and then sealed non-transparent envelopes are used to hide the random sequence, Blinding description: Participant: The participant is explained that if they are interested, they can join our research project. two methods used to reduce patient pain input study are explained to the patient. Benefits and possible complications of both methods are described to the patient and the patient is told to randomly fall into one of the intervention groups. If the patient is accepted to admit the study, by random allocation soft ware, the patient falls in to one of two groups. Clinical car giver: we teach the caregiver how to complete the questionnaier. This person is not aware of receiving patient intervention. Researcher: In this study does not have the ability to blind the reseacher because the researcher performs both intervention himself and is aware of receiving each intervention in the group. The outcome assessor of the complete questionnaires is given to person who is not aware of the interventions performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Date analyzer: questionnaire are finally given to a person to review the information. This person doesn't know any of the steps of the work, how to classify and the intervention performed. 3 Osteoarthritis of knee. Intervention 1: Intervention group: the group that receive 5cc mannitol 5%, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group. Intervention 2: Control group: group who received knee intra articular injection of hypertonic dextrose. Yes - There is a plan to make this available What will be shared: All available data can be shared after making people unidentifiable. When: Start access period one year after publishing the results. To whom: everyone can access to this information. Conditions: if the information in this study helps to improve the science process. Where to obtain: dr.nasrin.barzegar1975@gmail.com 00989173092357 How to obtain: After sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of three weeks if permitted. Comments:
public Nasrin Barzegar
No.11 , Ansar Ave., koohbor Blvd., Zerehi
Shiraz Iran (Islamic Republic of) 7184747811 +98 71 3648 6787 Dr.nasrin.barzegar1975@gmail.com Shiraz University of Medical Sciences scientific Nasrin Barzegar
No.11., Ansar Avn., koohbor Blvd., Zerehi
Shiraz Iran (Islamic Republic of) 7184747811 00986486787 Dr.nasrin.barzegar1975@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age: 38 to70 years old Gender: male or female Knee radiography anterior standing view have been for the last three month Have symptoms of osteoartritis include pain, crepitation for at least a month without any extra articular involvment 38 years 75 years Both Any injection of the knee joint during the last three of months sensitivity reaction to test drug The patient have done total knee arthroplasty The patient have diseases mimicking the symptoms of knee pain such as neuropathy and radiculopathy Diseases such as rheumatoid arthritis, Reiter's syndrom, gout Uncontrolled diabetes,HBA1c more than7.5, BMI more than 40 History of knee trauma,fracture Patient's mental disorder M17 Osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: the group that receive 5cc mannitol 5%, knee intra articular injection ,in three doses as the first dose and two weeks, four weeks , weeks after first dose and control group that receive 5cc of dextrose 25%,inter articular injection,as sequence of intervention group. Control group: group who received knee intra articular injection of hypertonic dextrose Knee pain. Timepoint: Two weeks ,foure weeks, eight weeks. Method of measurement: Visual Analogue Scale. Function of patient. Timepoint: two weeks, four weeks, eight weeks. Method of measurement: Oxford knee score. Shiraz University of Medical Sciences Approved 2019-07-28 Ethics committee of Shiraz School of Medicin No.11, Ansar Ave., Koohbor Blvd., Zerehi Shiraz Fars Iran (Islamic Republic of)