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IRCT20160422027520N13 IRCT 2019-08-14 Pishtaz teb zaman Co. Treatment of chronic knee osteoarthritis with Autologous Conditioned Serum OA The effects of Autologous Conditioned Serum therapy on chronic knee osteoarthritis 2019-08-23 anticipated 15 Complete https://irct.ir/trial/41180 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: The study participants were unaware of their placement in the study group (Autologous Conditioned Serum or normal saline). 2 Osteoarthritis. Intervention 1: Intervention group: Fifteen patients with knee osteoarthritis receive Autologous Conditioned Serum as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). In this group of patients, 10 ml of blood was taken by ACS-specific syringe manufactured by Pishtaz teb zaman CO. and after incubation of this syringe according to protocol kit, we separate the ACS. The ACS is then injected by a physician into one of the two knees of the patient with knee osteoarthritis. The injection volume of ACS is 2 cc.Repeat injections twice again 21 days apart.Then, in order to evaluate the effect of ACS on patients in the intervals and Compare it with another patient's knees who received normal saline, 1, 3 and 6 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded. Intervention 2: Control group: Fifteen patients with knee osteoarthritis receive normal saline (NS) as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). Then NS by the physician is injected into another patient's knee. Repeat injections twice again 21 days apart. Then, in order to evaluate the effect of NS on patients in the intervals and Compare it with another patient's knees who received ACS, at 1, 3 and 6 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded. 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 No more information
public Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Mehdi Yousefi
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614766 +98 41 3336 4665 yousefime@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Men and women between the ages of 18 and 75 with OA diagnosis based on the American College of Rheumatology Analog scale of knee pain (VAS) equal to or greater than 2.5 People with at least 4 months of history of pain or swelling in one or both knees Radiological classification scale Kellgren-Lawrence 1 or 2 The availability of individual during the study period BMI Between 20 and 35 18 years 75 years Both People under the age of 18 and over 75 years Pregnant women or women who are breastfeeding People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, rheumatoid arthritis, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome Those linked to acetaminophen or Vicodin or a history of drug misuse History of cortisone injections in the last 6 weeks The use of non-steroidal anti-inflammatory drugs 1 week ago Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ The use of inhibitors of platelet aggregation and anti-coagulation such as heparin History of knee surgery in the last 3 months Extraordinary deformation (varus >5ᵒ, valgus >5ᵒ) M15.4 Erosive (osteo)arthritis Treatment - Other Treatment - Other Intervention group: Fifteen patients with knee osteoarthritis receive Autologous Conditioned Serum as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). In this group of patients, 10 ml of blood was taken by ACS-specific syringe manufactured by Pishtaz teb zaman CO. and after incubation of this syringe according to protocol kit, we separate the ACS. The ACS is then injected by a physician into one of the two knees of the patient with knee osteoarthritis. The injection volume of ACS is 2 cc.Repeat injections twice again 21 days apart.Then, in order to evaluate the effect of ACS on patients in the intervals and Compare it with another patient's knees who received normal saline, 1, 3 and 6 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded. Control group: Fifteen patients with knee osteoarthritis receive normal saline (NS) as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). Then NS by the physician is injected into another patient's knee. Repeat injections twice again 21 days apart. Then, in order to evaluate the effect of NS on patients in the intervals and Compare it with another patient's knees who received ACS, at 1, 3 and 6 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded. Determining knee pain by VAS in all phases of clinical trial. Timepoint: Before injection and 1, 3 and 6 months after the first injection. Method of measurement: Questionnaire (VAS). Determination of knee function by WOMAC and KOOS in all phases of clinical trial. Timepoint: Before injection and 1, 3 and 6 months after the first injection. Method of measurement: Questionnaire (WOMAC), Questionnaire (KOOS). Determine the range of knee motion by manual joiniometry in all phases of clinical trial. Timepoint: Before injection and 1, 3 and 6 months after the first injection. Method of measurement: Range of motion (Degree). Pishtaz teb zaman Co. Approved 2019-07-15 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences , Daneshghah st, Tabriz, Tabriz East Azarbaijan Iran (Islamic Republic of)