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IRCT20210511051258N1 IRCT 2022-02-13 Birjand University of Medical Sciences Comparison of the effect of two types of intra-articular knee injections Comparison of the effect of two types of intra-articular injections including hyaluronic acid and corticosteroids in patients with mild to moderate knee osteoarthritis 2021-07-10 anticipated 50 Complete https://irct.ir/trial/56515 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assignment of patients in two groups will be using the random number table method. In this way, the researcher puts his hand on one of the numbers and starts moving in the right direction and records the numbers and assigns them to different groups. If he reaches an even number on the way, the person goes to the treatment group and if he reaches the number, the patient Will be placed in the control group. Based on the sample size of the research, a number of envelopes with aluminum wrappers are prepared in order to obscure the contents of the envelopes, and each of the random sequences created is recorded on a card, and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface, and finally the letter envelopes are glued and placed in a box, respectively, at the beginning of the registration of participants. According to the order of entry of eligible participants in the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, the first group will be treated with glucocorticoids and the second group will be treated with hyaluronic acid. 2-3 Osteoarthritis. Intervention 1: Intervention group: Injection of hyaluronic acid into the knee joint. Hyaluronic acid will be high molecular weight and will be injected once. The hyaluronic acid used will be of Iranian type and with Viscor brand from Nitka company. All injections will be performed by a physician to reduce any discrepancies in the type of injection to zero . Intervention 2: Control group: Intra-knee corticosteroid injection. The glucocorticoid used to treat these people is triamcinolone acetonide, which is FDA approved. In this group, 1 injection of corticosteroids in the amount of 1ml and 40mg is performed. The corticosteroid used is of the Iranian type and will be from Exir Company. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 3 months after the results are published To whom: Study data will be available to researchers working in academia and in industry, and who can apply for it. Conditions: The use of documents in articles and industry and medical applications will be allowed. Analyzes on data are also allowed. Where to obtain: To receive the required documents and data, you can send your request via the following e-mail: nn.mahdy10@gmail.com alireza.ghoreighi@bums.ac.ir How to obtain: After submitting the application in the announced manner and stating the reason for the request, the applicant must wait for the researcher to respond and obtain permission from the sponsoring body, after which, if agreed, the documents and data will be sent to him. Comments:
public Seyed Alireza ghoreishi
Ghaffari St., Birjand University of Medical Sciences
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ 098 56 32395000 alireza.ghoreishi@bums.ac.ir Birjand University of Medical Sciences scientific Seyed Alireza ghoreishi
Ghaffari St., Birjand University of Medical Sciences
Birjand Iran (Islamic Republic of) ۹۷۱۷۸۵۳۵۷۷ +98 56 3239 5000 alireza.ghoreishi@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Be between 50 and 70 years old. Have a visual acuity scale (VAS) score greater than 4 in the knee joint at the start of treatment. Absence of inflammatory joint disease Proof of osteoarthritis in patients with a WOMAC score of at least 60 out of 96 50 years 70 years Both Withdraw from the study Existence of severe cardiovascular diseases Existence of active infection and immune disorders People who are very young People with chronic diseases such as diabetes and hypertension, secondary osteoarthritis, systemic disorders, coagulopathies M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Injection of hyaluronic acid into the knee joint. Hyaluronic acid will be high molecular weight and will be injected once. The hyaluronic acid used will be of Iranian type and with Viscor brand from Nitka company. All injections will be performed by a physician to reduce any discrepancies in the type of injection to zero . Control group: Intra-knee corticosteroid injection. The glucocorticoid used to treat these people is triamcinolone acetonide, which is FDA approved. In this group, 1 injection of corticosteroids in the amount of 1ml and 40mg is performed. The corticosteroid used is of the Iranian type and will be from Exir Company. The amount of pain in the knee joints. Timepoint: Visual analog scale score measurement at the beginning of the study and 6 weeks later. Method of measurement: visual analog scale. Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Timepoint: WOMAC score set at the beginning of the study and 6 weeks later. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index questionnaire (WOMAC). Pain intensity score. Timepoint: Pain intensity measurement at the beginning of the study and 6 weeks later. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Intensity of joint stiffness. Timepoint: Measurement of joint stiffness at the beginning of the study and 6 weeks later. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Ability to perform daily activities score. Timepoint: Scoring the ability to perform daily activities at the beginning of the study and 6 weeks later. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC). Birjand University of Medical Sciences Approved 2021-03-01 Research Ethics Committees of Birjand University of Medical Sciences Ghaffari blvd, birjand medical university Birjand South Khorasan Iran (Islamic Republic of)