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IRCT20131124015515N6 IRCT 2019-04-13 Shahid Beheshti University of Medical Sciences Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis in patients with knee osteoarthritis Comparison of the effect of intra-articular injection of autologous and hyaluronic acid interleukin-1 (IL-1Ra) antagonist in controlling the pain of knee osteoarthritis in patients with knee osteoarthritis referring to pain clinics of Shohada Tajrish, Taleghani and Akhtar hospitals in 1397 2019-01-15 anticipated 60 Complete https://irct.ir/trial/38033 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: En: The sampling method was sequential; so that, all eligible people referred respectively, and were selected to complete the desired sample size. For randomization of patients into two groups, we used balanced block method and then informed consent has been obtained from the patients, Blinding description: Physicians who do the injections, data collectors, data analyzer and outcome assessors are unaware of the type of injected medication to each patient. 2-3 Knee Osteoarthritis. Intervention 1: Intervention group: Intra-articular injection of IL-1RA group: In order to prepare IL-1RA, 50 ml of venous blood is taken from the patient using the Orthokine syringe (manufacturer country: Germany, the manufacturer: orthokine) containing glass beads coated with CrSO4. Then, to ensure complete mixing and maximal contact of beads and blood, the syringe is rotated gently and stored immediately at 37 ° C and transferred to an Orthogen lab within 24 hours in a deignated incubator. In the laboratory, a blood sample is tested for hepatitis A, B and HIV, and if any of the tests are positive, the test is repeated with a new blood sample. If the test is re-affirmed positive, the patient is excluded from the study. In the event of negative test results, the products of orthokine (IL-1RA) are prepared by the laboratory and returned to the hospital in 2-14 ml vials at -20 ° C within 14-21 days. The injection regime in Orthokine (IL-1RA) group consists of 6 injections, on days 0, 3, 7, 10, 14 and 21 days after the first injection, and is done by physician A. Intervention 2: Intervention group: intra-articular injection of hyaluronic acid group: . Two milliliters of Hyaluronic acid solution (1% Synocrom, manufacturer CROMA, Austria) is injected into the knee joint. These patients receive five injections by physician B at intervals of one week. Yes - There is a plan to make this available What will be shared: The total potential data can be shared after unidentifiable people When: the access starts period 12 months after printing the results To whom: Researchers working in scientific and academic settings Conditions: To perform further studies based on our study protocol Where to obtain: Person responsible for scientific inquiries How to obtain: Sending Email Comments:
public Seyed Masoud Hashemi MD.
Akhtar Hospital, Sharifi Manesh st.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Seyed Masoud Hashemi MD.
Akhtar Hospital, Sharifi Manesh st.
Tehran Iran (Islamic Republic of) 1964714953 +98 21 2261 2252 dr.hashemi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Signed written informed consent to participate in the study Patients 40 years of age and above Patients suffering from knee osteoarthritis for more than 3 months Radiological findings confirming knee osteoarthritis based on the American College of Rheumatology (ACR) 40 years no limit Both Patients' refusal to participate in clinical research Patients with a history of knee surgery Patients with deformity and lower limb contraction, Patients with neuromascular disease of the lower extremity, Patients with acute lumbosacral pathology Patients undergone injection of steroid medications in the last two months Patients with a history of inflammatory rheumatoid arthritis Patients with infection Nursing mothers BMI > 35 patients with knee surgery Patient with knee deviations (verrucous or valgus more than 5 degrees) confirmed by three joint views Patients with knee radicular pain Patients with anticoagulant therapy Patients with post-traumatic arthritis Patient with history of Intra-articular injection or ozone therapy for the past 12 months Patients with allergy to any of the medications will be prescribed in this study Patients with systemic or psychiatric disease Patients with severe osteoarthritis of grade III Patients with intra-articular injection of hyaluronic acid in the past 12 months Patients with hepatitis Patients with HIV Patients with Cytomegalovirus Patient with Syphlis Patient with Osteomyelitis Alcohol or substance abuse Patient with diabetes Pregnancy M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Intervention group: Intra-articular injection of IL-1RA group: In order to prepare IL-1RA, 50 ml of venous blood is taken from the patient using the Orthokine syringe (manufacturer country: Germany, the manufacturer: orthokine) containing glass beads coated with CrSO4. Then, to ensure complete mixing and maximal contact of beads and blood, the syringe is rotated gently and stored immediately at 37 ° C and transferred to an Orthogen lab within 24 hours in a deignated incubator. In the laboratory, a blood sample is tested for hepatitis A, B and HIV, and if any of the tests are positive, the test is repeated with a new blood sample. If the test is re-affirmed positive, the patient is excluded from the study. In the event of negative test results, the products of orthokine (IL-1RA) are prepared by the laboratory and returned to the hospital in 2-14 ml vials at -20 ° C within 14-21 days. The injection regime in Orthokine (IL-1RA) group consists of 6 injections, on days 0, 3, 7, 10, 14 and 21 days after the first injection, and is done by physician A. Intervention group: intra-articular injection of hyaluronic acid group: . Two milliliters of Hyaluronic acid solution (1% Synocrom, manufacturer CROMA, Austria) is injected into the knee joint. These patients receive five injections by physician B at intervals of one week. Pain level. Timepoint: Before treatment, one month, three months and six months after the last injection. Method of measurement: En visual analog scale (VAS) (0 None; 1-3 Mild; 4-7 Moderate; 8-10 Severe). WOMAC Knee Score (Western Ontario & McMaster Universities Osteoarthritis Index ). Timepoint: Before treatment and three months after the last injection. Method of measurement: WOMAC Knee Score (Western Ontario & McMaster Universities Osteoarthritis Index ) Questionnaire. Knee injury and Osteoarthritis Outcome Score (KOOS). Timepoint: Before the intervention and 3 months after the last injection. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. Procedure side effects. Timepoint: 1, 3, 6 months after the injection procedure. Method of measurement: Documentation of the name of complication based on the findings of Pain Fellowship observation. Shahid Beheshti University of Medical Sciences Approved 2019-01-06 Ethics Committee on Biomedical Research Vice-Chancellor for Research in Shahid Beheshti University o Shahid Beheshti University of Medical Siences, Shahid Arabi Str, Velenjak Tehran Tehran Iran (Islamic Republic of)