Abstract / Summary
Background: Iliotibial band syndrome (ITBS) is a frequent cause of lateral knee pain among physically active individuals and is typically managed with activity modification, non-steroidal anti-inflammatory drugs, and structured physiotherapy. Although most patients respond to conservative treatment, a subset remains symptomatic and may require alternative therapeutic strategies. Platelet-rich plasma (PRP) has gained attention as a biologic therapy for various tendinopathies; however, evidence regarding its efficacy in ITBS is limited. Purpose: To evaluate the effectiveness of ultrasound-guided PRP injection compared with placebo in patients with refractory ITBS. Study design: Prospective, randomized, double-blind, placebo-controlled clinical trial; Level I evidence. Methods: Sixty patients aged 18–50 years with clinically and radiologically confirmed ITBS refractory to at least 12 weeks of conservative treatment were randomly assigned in a 1:1 ratio to receive either leukocyte-poor PRP (n = 30) or placebo saline injection (n = 30). Injections were performed under ultrasound guidance at the distal iliotibial band near the lateral femoral epicondyle. Randomization was conducted using a computer-generated block sequence with concealed allocation. Patients and outcome assessors were blinded to treatment allocation. The primary outcome was change in Visual Analog Scale (VAS) pain score at 6 months. Secondary outcomes included the Lower Extremity Functional Scale (LEFS), return-to-sport rate, and patient satisfaction. Sample size was calculated based on a clinically meaningful difference of 2 points in VAS, with a power of 80% and α = 0.05, accounting for an estimated 20% dropout. Results: At 6 months, the PRP group demonstrated a significantly greater reduction in VAS pain scores compared with the placebo group (mean difference 2.2 points; p < 0.001). Functional outcomes also improved significantly in the PRP group, with higher LEFS scores and a greater proportion of patients returning to sport. Patient satisfaction rates were higher in the PRP group. No serious adverse events were reported. Conclusion: Ultrasound-guided leukocyte-poor PRP injection resulted in significantly greater pain reduction and functional improvement compared with placebo in patients with refractory ITBS. PRP may represent a promising minimally invasive treatment option for patients who fail conservative management.