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IRCT20140907019073N7 IRCT 2023-10-12 Iran University of Medical Sciences Comparison of the effect of platelet-rich plasma injection activated by light radiation with platelet-rich plasma injection in the treatment of arthritis Comparative Study of The Effectiveness of The Injection of photo-activated Platelet Rich Plasma Compared with Platelet Rich Plasma on The Pain, Range of Motion and Function of Patients with Knee Osteoarthritis a double blind randomized control trial 2023-10-23 anticipated 40 Complete https://irct.ir/trial/71686 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients in treatment groups will be done randomly using blocks with 4 blocks in one of the treatment groups as follows: A: PRP B: PAPRP -Block1: AABB -Block2: ABAB -Block3: BBAA -Block 4: BABA, Blinding description: In this research, the following people will be compared to the treatment groups of blind patients: - The patients present in the research only know that they will be injected and will not know about the type of PRP used. Also, in this research, injection interventions will be performed under the supervision of a sports medicine specialist who does not know about the type of PRP and only injects the solution obtained with a glass syringe into the joint. - Assessor Clinician: Evaluations before and after interventions in the sports medicine assessment clinic are performed by the sports medicine resident who is not aware of the presence of patients in the groups. - Statistical Consultant and Analyzer: The analysis of the research data will be done by a statistical consultant who is not aware of the patient groups. 3 Knee osteoarthritis. Intervention 1: Control group: They are injected with platelet-rich plasma and this injection is repeated after one month. Preparation of solution and injection of PRP will be done in sports medicine clinic of Hazrat Rasool Akram (PBUH) hospital. Patients are asked to stop taking anticoagulants and aspirin (if used) a week before the injection with the permission of their doctor. To prepare PRP, kits (Arya Mabna Tashkis Corporation, RN: 312569, Rooyagen Kit) are used, which have a completely sterile pack. In order to prepare the injection solution, 35 cc of venous blood from the upper limb is taken from the patients by a 50 cc syringe, which has already drawn 5 cc of anticoagulant solution, and with the help of a blood transfusion adapter with an 18 G needle head and without any pressure on the piston, it is taken into the four A sterile tube is transferred. At the same time, about 0.5 cc of the patient's blood will be sent to the laboratory of Hazrat Rasool Akram Hospital to check the amount of his blood cells. All 4 tubes are filled in a balanced manner and placed inside the centrifuge and rotated at a speed of 1600 RPM for 10 minutes. placed and then the tubes are removed. Then the plasma separated by the first centrifuge in the tubes is drawn and poured into two other sterile 10 cc tubes inside the box that contain 0.6 cc of preservative with anti-platelet aggregation effect. Then it is put back into the machine and centrifuged at 3500RPM for 6 minutes. Then, after removing the upper plasma, 3 cc from the ends of each 2 tubes are drawn by a 5 cc syringe with a 14G needle and about 0.5 cc is separated to send to the laboratory. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients avoid weight bearing and heavy activities for 48 hours after injection. One of the most important ways to treat patients with knee osteoarthritis is the use of therapeutic exercises. A common exercise protocol will be prescribed for knee osteoarthritis patients participating in this study. Intervention 2: Intervention group: Under the injection of platelet-rich plasma that is irradiated with light before the injection for activation, and this injection is repeated after one month. In the PAPRP group, PRP is prepared like the first group and put into a sterile glass tube. transferred (the tubes of the kits used for PRP, including the kit we used in this study, are mainly made of compressed PVC and to prevent the absorption of light by these tubes and the possible interference with the effect of light on the activation of platelets for the radiation of solution light Sterile glass tubes are used) and the pre-injection glass tube is placed at a distance of 10 cm from the light source, which is a Bioptron PRO1 device with a wavelength of 3400-480 nm, for 5 minutes and then in the same way as before. It is ready to be injected. During the injection, the patient lies in a quiet environment and in the supine arch position, and the injected knee is placed in a 45 degree flexion position. The prepared PRP solution drawn into the syringe is slowly injected from the Infero Lateral area of the knee with a G14 needle head. After a 30-minute rest under the supervision of a sports medicine specialist, the patient is allowed to leave the clinic using a wheelchair. In case of pain, Yemar can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients avoid weight bearing and heavy activities for 48 hours after injection. One of the most important ways to treat patients with knee osteoarthritis is the use of therapeutic exercises. A common exercise protocol will be prescribed for knee osteoarthritis patients participating in this study. Yes - There is a plan to make this available What will be shared: IPD collection for the primary and secondary outcomes When: Immediately after publication To whom: People working in academic institution Conditions: The result of further analysis may not be presented to public without permission. Where to obtain: Mazaherinezhad.a@iums.ac.ir How to obtain: A reasonable request from an academic source will be responded within 10 working days Comments:
public Ali Mazaherinezhad
Hazrate-rasool-Hospital
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2446 mazaherinezhad.a@iums.ac.ir Iran University of Medical Sciences scientific Ali Mazaherinezhad
Hazrate-rasool-Hospital
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2446 mazaherinezhad.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Having primary knee osteoarthritis grade 2 and 3 according to the doctor's diagnosis and based on the Kellgren and Lawrence criteria (the presence of knee pain, morning dryness for less than 30 minutes, crypts during movement and radiological signs of osteoarthritis including joint space reduction, subchondral bone sclerosis and osteophyte formation in the knee ) Age 50-75 years Having persistent knee pain for at least six months with a severity of at least 4 based on the VAS scale in activities such as going up and down the stairs, sitting for a long time and squatting Ability to walk independently for at least 30 meters Body mass index equal to or less than 35 Complete consent of the patient to participate in the research Balanced mental state 50 years 75 years Both History of intra-articular injections in the knee during the last six months Having neuromuscular diseases Presence of acute traumatic injury in other ligaments and structures of the knee joint as confirmed by a specialist doctor History of previous surgery or injury in the knee and other joints of the lower limbs during the last year Presence of bone implants The presence of new fractures in the lower limbs during the last year Getting malignant tumors Participation in sports therapy and physiotherapy programs during the last three months M17 Osteoarthritis of knee Treatment - Drugs Treatment - Drugs Control group: They are injected with platelet-rich plasma and this injection is repeated after one month. Preparation of solution and injection of PRP will be done in sports medicine clinic of Hazrat Rasool Akram (PBUH) hospital. Patients are asked to stop taking anticoagulants and aspirin (if used) a week before the injection with the permission of their doctor. To prepare PRP, kits (Arya Mabna Tashkis Corporation, RN: 312569, Rooyagen Kit) are used, which have a completely sterile pack. In order to prepare the injection solution, 35 cc of venous blood from the upper limb is taken from the patients by a 50 cc syringe, which has already drawn 5 cc of anticoagulant solution, and with the help of a blood transfusion adapter with an 18 G needle head and without any pressure on the piston, it is taken into the four A sterile tube is transferred. At the same time, about 0.5 cc of the patient's blood will be sent to the laboratory of Hazrat Rasool Akram Hospital to check the amount of his blood cells. All 4 tubes are filled in a balanced manner and placed inside the centrifuge and rotated at a speed of 1600 RPM for 10 minutes. placed and then the tubes are removed. Then the plasma separated by the first centrifuge in the tubes is drawn and poured into two other sterile 10 cc tubes inside the box that contain 0.6 cc of preservative with anti-platelet aggregation effect. Then it is put back into the machine and centrifuged at 3500RPM for 6 minutes. Then, after removing the upper plasma, 3 cc from the ends of each 2 tubes are drawn by a 5 cc syringe with a 14G needle and about 0.5 cc is separated to send to the laboratory. In case of pain, the patient can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients avoid weight bearing and heavy activities for 48 hours after injection. One of the most important ways to treat patients with knee osteoarthritis is the use of therapeutic exercises. A common exercise protocol will be prescribed for knee osteoarthritis patients participating in this study. Intervention group: Under the injection of platelet-rich plasma that is irradiated with light before the injection for activation, and this injection is repeated after one month. In the PAPRP group, PRP is prepared like the first group and put into a sterile glass tube. transferred (the tubes of the kits used for PRP, including the kit we used in this study, are mainly made of compressed PVC and to prevent the absorption of light by these tubes and the possible interference with the effect of light on the activation of platelets for the radiation of solution light Sterile glass tubes are used) and the pre-injection glass tube is placed at a distance of 10 cm from the light source, which is a Bioptron PRO1 device with a wavelength of 3400-480 nm, for 5 minutes and then in the same way as before. It is ready to be injected. During the injection, the patient lies in a quiet environment and in the supine arch position, and the injected knee is placed in a 45 degree flexion position. The prepared PRP solution drawn into the syringe is slowly injected from the Infero Lateral area of the knee with a G14 needle head. After a 30-minute rest under the supervision of a sports medicine specialist, the patient is allowed to leave the clinic using a wheelchair. In case of pain, Yemar can take acetaminophen without codeine and is not allowed to take aspirin for 10 days. It is recommended that patients avoid weight bearing and heavy activities for 48 hours after injection. One of the most important ways to treat patients with knee osteoarthritis is the use of therapeutic exercises. A common exercise protocol will be prescribed for knee osteoarthritis patients participating in this study. Feeling knee pain by Visual Analogue Scale (VAS). Timepoint: The time of follow-up of patients is zero months (first visit), one and six months. Method of measurement: with the VAS questionnaire. Knee function with WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) scale. Timepoint: The time of follow-up of patients is zero months (first visit), one and six months. Method of measurement: with WOMAC questionnaire. Knee range of motion. Timepoint: The time of examination of patients is in zero months (initial visit), one and six months. Method of measurement: Goniometry. Timed Up & Go test: The ability of a person to get up from a chair over a distance of 3 meters and return to the chair. Timepoint: The time of examination of patients is in zero months (initial visit), one and six months. Method of measurement: Stopwatch (seconds). Six Minute Walk test: The person's ability to walk for 6 minutes. Timepoint: The time of examination of patients is in zero months (initial visit), one and six months. Method of measurement: Distance measurement (meter). Stair climbing test: The ability of a person to climb stairs to reach the stage of pain or fatigue. Timepoint: The time of examination of patients is in zero months (initial visit), one and six months. Method of measurement: The number of steps taken. Iran University of Medical Sciences Approved 2023-10-07 Iran University of Medical Sciences Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)