]>
IRCT20230823059241N1 IRCT 2023-09-27 Ardabil University of Medical Sciences Ozone injection combined with hyaluronic acid compared to hyaloronic injection in the treatment of knee osteoarthritis Investigating the effects of ozone injection combined with hyaluronic acid compared to hyaluronic injection in the treatment of knee osteoarthritis in patients referred to the orthopedic clinic and the pain clinic of Fatemi Ardabil Hospital. 2023-10-23 anticipated 60 Complete https://irct.ir/trial/72414 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two groups receiving hyaluronic acid and ozone with hyaluronic acid. Simple randomization and lottery will be used for randomization. Cards and envelopes are prepared according to the number of the research sample and an equal number of names of groups A and B are recorded on each card. The cards are placed inside the letter envelopes. The lid of the letter envelopes is glued and placed inside a box. At the start of the study, according to the order of entry of the participants, the patient will take one of the envelopes from the box and will be placed in one of the two study groups based on the group written on the card, Blinding description: Patients in one group will receive hyaluronic acid and patients in the other group will receive ozone along with hyaluronic acid. Patients and doctors who evaluate the outcome will be unaware of the type of drug received. 3 Osteoartritis in knee. Intervention 1: Intervention group: 2 cc of intra-articular hyaluronic acid (Nitca company, 2 mg) on three occasions with an interval of one week. Intervention 2: Intervention group: 2 cc of intra-articular hyaluronic acid (Nitca company, 2 mg) and 10 cc of 25% ozone in three sessions with an interval of one week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The results are not yet known
public Maryam Asayeshi
Fatemi hospital, Imam Khomeini street, Ardabil
Ardabil Iran (Islamic Republic of) 5614733775 +98 45 3323 2520 maryamasayeshi88@gmail.com Ardabil University of Medical Sciences scientific Maryam Asayeshi
Fatemi hospital, Imam Khomeini street, Ardabil
Ardabil Iran (Islamic Republic of) 5614733775 +98 45 3323 2520 maryamasayeshi88@gmail.com Ardabil University of Medical Sciences Iran (Islamic Republic of) Osteoartitis grade 1&2 no limit no limit Both Pregnancy or breastfeeding Taking anticoagulants Intra-articular drug use during the last 6 months History of knee surgery M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: 2 cc of intra-articular hyaluronic acid (Nitca company, 2 mg) on three occasions with an interval of one week Intervention group: 2 cc of intra-articular hyaluronic acid (Nitca company, 2 mg) and 10 cc of 25% ozone in three sessions with an interval of one week. Pain. Timepoint: The moment of entry, the second week, the second month and the sixth month after the intervention. Method of measurement: Visual Analog Scale. Quality of Life. Timepoint: The moment of entry, the second week, the second month and the sixth month after the intervention. Method of measurement: SF-36 questionnaire. Sleep quality. Timepoint: The moment of entry, the second week, the second month and the sixth month after the intervention. Method of measurement: Pittsburgh Questionnaire. Ardabil University of Medical Sciences Approved 2023-07-22 Ethics committee of Ardabil University of Medical Sciences Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil Ardabil Ardabil Iran (Islamic Republic of)