Evaluation of safety and efficacy of Urtica dioica cataplasm in the Management of Osgood-Schlatter Disease in Young Athletes: A study protocol for randomized, double-blind, placebo controlled clinical trial

Background Osgood-Schlatter disease (OSD) is a common cause of knee pain in young athletes, often requiring rest and standard care for symptom relief. Urtica dioica , a medicinal plant traditionally used for musculoskeletal conditions, may offer a natural alternative. This study aims to evaluate the clinical efficacy and safety of Urtica dioica cataplasm (UDC) for the management of OSD in comparison to standard care. Methods This is a single-center, phase II, randomized, double-blind, placebo-controlled clinical trial. A total of 180 young athletes diagnosed with OSD will be randomly assigned in a 1:1:1 ratio to receive either UDC, placebo, or standard care consisting of rest and vitamin D supplementation. Participants in the UDC and placebo groups will receive topically applied cataplasms twice weekly for six weeks. Functional outcomes will be assessed using the KOOS-Child questionnaire, encompassing five subscales: pain, symptoms, daily living activities, sports and recreation, and knee-related quality of life. Pain intensity will be measured using the Visual Analogue Scale (VAS). Assessments will be performed at baseline, at 6 weeks (end of intervention), and at 3 months post-treatment to evaluate both short- and mid-term effects. Adverse events will be recorded at each follow-up visit. Discussion This is the first randomized clinical trial to investigate the use of UDC in pediatric OSD management. It is hypothesized that UDC will improve knee function, reduce pain severity, and enhance quality of life in affected individuals. Furthermore, it may shorten the rest period required before returning to sports activities, providing a promising complementary option for young athletes. The outcomes of this study could support the integration of safe, plant-based therapeutics into pediatric musculoskeletal care. Trial Registration The trial is prospectively approved and registered by the Human Research Ethics Committee of the Faculty of Medicine of Sousse, Tunisia [CEFMSo_0061_2025, 28/05/2025] and registered at ClinicalTrials.gov under the identifier NCT07096037 (https://clinicaltrials.gov/study/NCT07096037, 30/07/2025).