Comparison of intra-articular platelet-rich plasma injection versus placebo for clinical outcomes in patients with knee osteoarthritis; a double-blind, randomized trial

Introduction: Osteoarthritis (OA) is a progressively debilitating condition that leads to musculoskeletal pain, particularly in the knee joint. Most clinical guidelines recommend platelet-rich plasma (PRP) for knee OA. However, the use of PRP in knee OA is increasing. Objectives: This study aimed to investigate the effects of intra-articular administration of PRP on the symptoms, lower limb function, and daily living activities in patients with knee OA. Patients and Methods: A double-blind, randomized, controlled clinical trial was conducted and 34 patients with grade 2 or 3 knee OA were enrolled. The knees of each participant were randomly allocated to receive either 3cc PRP injection (PRP knees) or needling only (control knees). Patients were evaluated by a general practitioner before, three, and six months after the intervention using the EuroQol-visual analog scales (EQ-VAS), the International Knee Documentation Committee (IKDC), the Western Ontario and McMaster Universities Arthritis Index (WOMAC), and the Tegner Activity Score (TAS). Results: The mean (±SD) age of patients with knee OA was 56.6 ± 10.2 years. Seventy-point-six percent of patients were female. 67.6% and 32.4% of patients were in stages 2 and 3 of the disease, respectively. IKDC, WOMAC, TAS, and EQ-VAS scores in knees under PRP injection and control of knees, three and six months after injection showed significant improvement. Three and six months after the intervention, IKDC, WOMAC, TAS, and EQ-VAS scores in the PRP and control knees were not significant (P > 0.05). Inter-group comparison indicated that the IKDC score significantly increased six months in comparison to three months (P = 0.048) in PRP knees, but not significant in the control knees (P = 0.133). TAS score in PRP and control knees significantly increased six months compared to three months after injection. WOMAC and EQ-VAS score in PRP and control knees was not significant at six months in comparison to three months after the intervention. Conclusion: Our findings could suggest safety and feasibility data for the intra-articular administration of PRP in patients with knee OA that may help to appraise a larger clinical trial. Findings show that PRP injection improves IKDC, WOMAC, TAS, and EQ-VAS scores, however, there was no significant difference with needling only (control knees). Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trial (identifier: IRCT2015010112823N2; https://en.irct.ir/trial/12827, Ethics committee reference number: 93/551664) and Research Registry (Research Registry Unique Identifying Number: researchregistry9843).

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