]>
IRCT20221111056470N1 IRCT 2022-12-10 Shiraz University of Medical Sciences Comparison between the efficacy of ultrasound-guided dextrose 25% hypertonic prolotherapy and intraarticular normal saline injection on pain, functional limitation and range of motion; in knee osteoarthritis patients Comparison between the efficacy of ultrasound-guided dextrose 25% hypertonic prolotherapy and intraarticular normal saline injection on pain, functional limitation and range of motion; in knee osteoarthritis patients 2022-11-16 anticipated 50 Complete https://irct.ir/trial/66819 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To match patients in the intervention and control groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation blocks randomization method with 4 samples in each block and a random list of data will be obtained by using Random Allocation software. We will have two lists of 25patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups, 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. N/A knee osteoarthritis. Intervention 1: Intervention group: The group that received 25% dextrose hyper-tonic intra-articularly under ultrasound guidance. Intervention 2: Control group: The group that received normal saline intra-articularly under ultrasound guidance. 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: nafis_bg@yahoo.com 00989132052155 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 Nafiseh Birang
No. 103., Sadi Dead End., Bijan Alley., Hakim Nezami Ave
Esfahan Iran (Islamic Republic of) 8175979967 +98 31 3624 1170 nafis_bg@yahoo.com Shiraz University of Medical Sciences scientific Nafiseh Birang
No. 103., Sadi Dead End., Bijan Alley., Hakim Nezami Ave
Esfahan Iran (Islamic Republic of) 8175979967 +98 31 3624 1170 nafis_bg@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: aged 55 to75 years; both genders; knee radiography anterior standing view have been for the last one month; have symptoms of osteoarthritis include pain, limitation in knee range of motion , and knee joint dryness for at least a month without any extra-articular involvement. 55 years 75 years Both Inflammatory and vascular collagen diseases such as lupus and suspected knee infection, patients with coagulation disorders, patients with active lumbosacral radiculopathy and severe deformity of the spine and lower limbs, peripheral and central nervous system disorders, pregnancy, diabetes, history of surgery on the knee, injection of steroid drugs in the last two months or intra-articular injection of hyaluronic acid in the last 12 months or replacement of the knee joint, use of opioid drugs, body mass index over 40 M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: The group that received 25% dextrose hyper-tonic intra-articularly under ultrasound guidance. Control group: The group that received normal saline intra-articularly under ultrasound guidance. Pain scale. Timepoint: Just before the intervention & 2,4,8 weeks later. Method of measurement: Visual Analogue Scale,Western Ontario and McMaster Universities Arthritis Index (WOMAC). Knee flexion degree. Timepoint: Just before the intervention & 2,4,8 weeks later. Method of measurement: goniometry. Functional limitation. Timepoint: Just before the intervention & 2,4,8 weeks later. Method of measurement: Oxford knee score and Western Ontario and McMaster Universities Arthritis Index (WOMAC). Shiraz University of Medical Sciences Approved 2022-11-12 Ethics committee of Shiraz University of Medical Sciences No. 103., Sadi Dead End., Bijan Alley., Hakim Nezami Ave Esfahan Isfehan Iran (Islamic Republic of)