Seyed Ahmad Raeissadat1,2, Parsa Ghazi Hosseini1,2, Mohammad Hasan Bahrami2,3, Reza Salman Roghani2,4, Mohammad Fathi5,6, Azadeh Gharooee Ahangar7,8, Mahtab Darvish1,2. 1. Clinical Development Research Center of Shahid Modarres Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 2. Physical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 3. Shohada-e-Tajrish Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 4. Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Stockholm, Sweden. 5. Critical Care Fellowship, Department of Anesthesiology, Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 6. Critical Care Quality Improvement Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. 7. Clinical Development Research Center of Shahid Modarres Hospital, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. dr.azadeh.g.ahangar@gmail.com. 8. Physical Medicine and Rehabilitation Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. dr.azadeh.g.ahangar@gmail.com.
Abstract
BACKGROUND: Our study compare the short and long-term efficacy of the intra articular injections (IAIs) of hyaluronic acid (HA), platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), and ozone in patients with knee osteoarthritis (OA). METHODS: In this randomized clinical trial, 238 patients with mild to moderateknee OA were randomized into 4 groups of IAIs: HA (3 doses weekly), PRP (2 doses with 3 weeks interval), PRGF (2 doses with 3 weeks interval), and Ozone (3 doses weekly). Our outcome measures were the mean changes from baseline (immediately from the first injections) until 2,6, and 12 months post intervention in scores of visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. RESULTS: A total of 200 patients enrolled in the final analysis. The mean age of patients was 56.9 ± 6.3 years, and 69.5% were women. In 2 months follow up, significant improvement of pain, stiffness, and function were seen in all groups compared to the baseline, but the ozone group had the best results (P < 0.05). In 6 month follow up HA, PRP, and PRGF groups demonstrated better therapeutic effects in all scores in comparison with ozone (P < 0.05). At the end of the 12th month, only PRGF and PRP groups had better results versus HA and ozone groups in all scores (P < 0.05). Despite the fact that ozone showed better early results, its effects begin to wear off earlier than other products and ultimately disappear in 12 months. CONCLUSIONS:Ozone injection had rapid effects and better short-term results after 2 months, but its therapeutic effects did not persist after 6 months and at the 6-month follow up, PRP,PRGF and HA were superior to ozone. Only patients in PRP and PRGF groups improved symptoms persisted for 12 months. Therefore, these products could be the preferable choices for long-term management. TRIAL REGISTRATION: Registered in the Iranian Center of Clinical Trials ( www.irct.ir ) in 11/11/2017 with the following code: IRCT2017082013442N17.
RCT Entities:
BACKGROUND: Our study compare the short and long-term efficacy of the intra articular injections (IAIs) of hyaluronic acid (HA), platelet-rich plasma (PRP), plasma rich in growth factors (PRGF), and ozone in patients with knee osteoarthritis (OA). METHODS: In this randomized clinical trial, 238 patients with mild to moderate knee OA were randomized into 4 groups of IAIs: HA (3 doses weekly), PRP (2 doses with 3 weeks interval), PRGF (2 doses with 3 weeks interval), and Ozone (3 doses weekly). Our outcome measures were the mean changes from baseline (immediately from the first injections) until 2,6, and 12 months post intervention in scores of visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Lequesne index. RESULTS: A total of 200 patients enrolled in the final analysis. The mean age of patients was 56.9 ± 6.3 years, and 69.5% were women. In 2 months follow up, significant improvement of pain, stiffness, and function were seen in all groups compared to the baseline, but the ozone group had the best results (P < 0.05). In 6 month follow up HA, PRP, and PRGF groups demonstrated better therapeutic effects in all scores in comparison with ozone (P < 0.05). At the end of the 12th month, only PRGF and PRP groups had better results versus HA and ozone groups in all scores (P < 0.05). Despite the fact that ozone showed better early results, its effects begin to wear off earlier than other products and ultimately disappear in 12 months. CONCLUSIONS:Ozone injection had rapid effects and better short-term results after 2 months, but its therapeutic effects did not persist after 6 months and at the 6-month follow up, PRP,PRGF and HA were superior to ozone. Only patients in PRP and PRGF groups improved symptoms persisted for 12 months. Therefore, these products could be the preferable choices for long-term management. TRIAL REGISTRATION: Registered in the Iranian Center of Clinical Trials ( www.irct.ir ) in 11/11/2017 with the following code: IRCT2017082013442N17.
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